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    T A B L E O F C O N T E N T S

    1HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    1 ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    2PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    3BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    4METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    8RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

    Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

    13DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    14 AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    14 ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    14REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    18CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    47DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

     Analysis 1.1. Comparison 1 Methods of performing the uterine incision: auto stapler versus conventional, Outcome 1

    Febrile morbidity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 Analysis 1.2. Comparison 1 Methods of performing the uterine incision: auto stapler versus conventional, Outcome 2

    Mean blood loss. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

     Analysis 1.3. Comparison 1 Methods of performing the uterine incision: auto stapler versus conventional, Outcome 3

    Duration of surgery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

     Analysis 1.4. Comparison 1 Methods of performing the uterine incision: auto stapler versus conventional, Outcome 4

    Duration of postnatal stay. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

     Analysis 1.5. Comparison 1 Methods of performing the uterine incision: auto stapler versus conventional, Outcome 5

     Wound complications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

     Analysis 1.6. Comparison 1 Methods of performing the uterine incision: auto stapler versus conventional, Outcome 6 Need

    for blood transfusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

     Analysis 1.7. Comparison 1 Methods of performing the uterine incision: auto stapler versus conventional, Outcome 7

    Endometritis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

     Analysis 2.1. Comparison 2 Methods of performing the uterine incision: blunt versus sharp dissection, Outcome 1Postoperative febrile morbidity (including endometritis). . . . . . . . . . . . . . . . . . . . 52

     Analysis 2.2. Comparison 2 Methods of performing the uterine incision: blunt versus sharp dissection, Outcome 2 Mean

    blood loss. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

     Analysis 2.3. Comparison 2 Methods of performing the uterine incision: blunt versus sharp dissection, Outcome 3 Need

    for blood transfusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

     Analysis 2.4. Comparison 2 Methods of performing the uterine incision: blunt versus sharp dissection, Outcome 4 Maternal

    death or serious morbidity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

     Analysis 2.5. Comparison 2 Methods of performing the uterine incision: blunt versus sharp dissection, Outcome 5

    Duration of surgery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

     Analysis 3.1. Comparison 3 Methods of performing the uterine incision: transverse versus cephalad-caudad blunt extension,

    Outcome 1 Mean blood loss. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

     Analysis 3.2. Comparison 3 Methods of performing the uterine incision: transverse versus cephalad-caudad blunt extension,

    Outcome 2 Need for blood transfusion. . . . . . . . . . . . . . . . . . . . . . . . . . 56 Analysis 3.3. Comparison 3 Methods of performing the uterine incision: transverse versus cephalad-caudad blunt extension,

    Outcome 3 Duration of surgery. . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

     Analysis 4.1. Comparison 4 Single layer uterine closure versus double layer uterine closure, Outcome 1 Postoperative febrile

    morbidity (including endometritis). . . . . . . . . . . . . . . . . . . . . . . . . . . 57

     Analysis 4.2. Comparison 4 Single layer uterine closure versus double layer uterine closure, Outcome 2 Blood loss greater

    than 500 mL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

     Analysis 4.3. Comparison 4 Single layer uterine closure versus double layer uterine closure, Outcome 3 Need for blood

    transfusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

    iSurgical techniques for uterine incision and uterine closure at the time of caesarean section (Review)

    Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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     Analysis 4.4. Comparison 4 Single layer uterine closure versus double layer uterine closure, Outcome 4 Wound infection. 59

     Analysis 4.5. Comparison 4 Single layer uterine closure versus double layer uterine closure, Outcome 5 Operative procedure

    on wound. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

     Analysis 4.6. Comparison 4 Single layer uterine closure versus double layer uterine closure, Outcome 6 Postoperative

    anaemia. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

     Analysis 4.7. Comparison 4 Single layer uterine closure versus double layer uterine closure, Outcome 7 Complication of future pregnancy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

     Analysis 4.8. Comparison 4 Single layer uterine closure versus double layer uterine closure, Outcome 8 Postoperative pain

    present. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

     Analysis 4.9. Comparison 4 Single layer uterine closure versus double layer uterine closure, Outcome 9 Complications post-

    op requiring re-laparotomy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

     Analysis 4.10. Comparison 4 Single layer uterine closure versus double layer uterine closure, Outcome 10 Length of hospital

    stay. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

     Analysis 4.11. Comparison 4 Single layer uterine closure versus double layer uterine closure, Outcome 11 Death or serious

    maternal morbidity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

     Analysis 4.12. Comparison 4 Single layer uterine closure versus double layer uterine closure, Outcome 12 Maternal

    readmission. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

     Analysis 5.1. Comparison 5 Techniques for closing the uterus: chromic catgut versus polygactin-910, Outcome 1

    Postoperative febrile morbidity (including endometritis). . . . . . . . . . . . . . . . . . . . 65 Analysis 5.2. Comparison 5 Techniques for closing the uterus: chromic catgut versus polygactin-910, Outcome 2 Need for

    blood transfusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

     Analysis 5.3. Comparison 5 Techniques for closing the uterus: chromic catgut versus polygactin-910, Outcome 3 Wound

    infection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

     Analysis 5.4. Comparison 5 Techniques for closing the uterus: chromic catgut versus polygactin-910, Outcome 4 Operative

    procedure on wound. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

     Analysis 5.5. Comparison 5 Techniques for closing the uterus: chromic catgut versus polygactin-910, Outcome 5

    Postoperative pain present. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

     Analysis 5.6. Comparison 5 Techniques for closing the uterus: chromic catgut versus polygactin-910, Outcome 6

    Complications post-op requiring re-laparotomy. . . . . . . . . . . . . . . . . . . . . . . 68

     Analysis 5.7. Comparison 5 Techniques for closing the uterus: chromic catgut versus polygactin-910, Outcome 7 Death or

    serious maternal morbidity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

     Analysis 5.8. Comparison 5 Techniques for closing the uterus: chromic catgut versus polygactin-910, Outcome 8 Maternalreadmission. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

    69 APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    70 WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    70HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    70CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    71DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    71DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . . .

    71INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    iiSurgical techniques for uterine incision and uterine closure at the time of caesarean section (Review)

    Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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    [Intervention Review]

    Surgical techniques for uterine incision and uterine closure atthe time of caesarean section

     Jodie M Dodd1 , Elizabeth R Anderson2, Simon Gates3, Rosalie M Grivell1

    1School of Paediatrics and Reproductive Health, Discipline of Obstetrics and Gynaecology, The University of Adelaide, Women’s and

    Children’s Hospital, Adelaide, Australia.   2Department of Genito-urinary Medicine, Royal Liverpool University Hospital, Liverpool,

    UK. 3 Warwick Clinical Trials Unit, Division of Health Sciences, Warwick Medical School, The University of Warwick, Coventry, UK 

    Contact address: Jodie M Dodd, School of Paediatrics and Reproductive Health, Discipline of Obstetrics and Gynaecology, The

    University of Adelaide, Women’s and Children’s Hospital, 72 King William Road, Adelaide, South Australia, 5006, Australia.

     [email protected].

    Editorial group: Cochrane Pregnancy and Childbirth Group.

    Publication status and date: New search for studies and content updated (conclusions changed), published in Issue 7, 2014.

    Review content assessed as up-to-date:  1 September 2013.

    Citation:   Dodd JM, Anderson ER, Gates S, Grivell RM. Surgical techniques for uterine incision and uterine closure at the time of cae-

    sarean section. CochraneDatabase of SystematicReviews 2014,Issue 7. Art. No.: CD004732. DOI:10.1002/14651858.CD004732.pub3.

    Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

    A B S T R A C T

    Background

    Caesarean section is a common operation. Techniques vary depending on both the clinical situation and the preferences of the operator.

    Objectives

    To compare the effects of 1) different types of uterine incision, 2) methods of performing the uterine incision, 3) suture materials and

    technique of uterine closure (including single versus double layer closure of the uterine incision) on maternal health, infant health, and

    healthcare resource use.

    Search methods

     We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (1 September 2013) and reference lists of all identified

    papers.

    Selection criteria 

     All published, unpublished, and ongoing randomised controlled trials comparing various types and closure of uterine incision during 

    caesarean section.

    Data collection and analysis

    Two review authors evaluated trials for inclusion and methodological quality without consideration of their results according to the

    stated eligibility criteria and extracted data independently.

    Main results

    Our search strategy identified60 studies for consideration, of which27 randomisedtrials involving17,808 womenundergoing caesarean

    section were included in the review. Overall, the methodological quality of the trials was variable, with 12 of the 27 included trials

    adequately describing the randomisation sequence, with less than half describing adequately methods of allocation concealment, and

    only six trials indicating blinding of outcome assessors.

    1Surgical techniques for uterine incision and uterine closure at the time of caesarean section (Review)

    Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

    mailto:[email protected]:[email protected]

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    Two trials compared auto-suture devices with traditional hysterotomy involving 300 women. No statistically significant difference in

    febrile morbidity between the stapler and conventional incision groups was apparent (risk ratio (RR) 0.92; 95% confidence interval

    (CI) 0.38 to 2.20).

    Five studies were included in the review that compared blunt versus sharp dissection when performing the uterine incision involving 

    2141 women. There were no statistically significant differences identified for the primary outcome febrile morbidity following blunt

    or sharp extension of the uterine incision (four studies; 1941 women; RR 0.86; 95% CI 0.70 to 1.05). Mean blood loss (two studies;1145 women; average mean difference (MD) -55.00 mL; 95% CI -79.48 to -30.52), and the need for blood transfusion (two studies;

    1345 women; RR 0.24; 95% CI 0.09 to 0.62) were significantly lower following blunt extension.

     A single trial compared transverse with cephalad-caudad blunt extension of the uterine incision, involving 811 women, and while mean

    blood loss was reported to be lower following transverse extension (one study; 811 women; MD 42.00 mL; 95% CI 1.31 to 82.69),

    the clinical significance of such a small volume difference is of uncertain clinical relevance. There were no other statistically significant

    differences identified for the limited outcomes reported.

     A single trial comparing chromic catgut with polygactin-910, involving 9544 women reported that catgut closure versus closure with

    polygactin was associated with a significant reduction in the need for blood transfusion (one study, 9544 women, RR 0.49, 95% CI

    0.32 to 0.76) and a significant reduction in complications requiring re-laparotomy (one study, 9544 women, RR 0.58, 95% CI 0.37

    to 0.89).

    Nineteen studies were identified comparing single layer with double layer closure of the uterus, with data contributed to the meta-analyses from 14 studies. There were no statistically significant differences identified for the primary outcome, febrile morbidity (nine

    studies; 13,890 women; RR 0.98; 95% CI 0.85 to 1.12). Although the meta-analysis suggested single layer closure was associated with

    a reduction in mean blood loss, heterogeneity is high and this limits the clinical applicability of the result. There were no differences

    identified in risk of blood transfusion (four studies; 13,571 women; average RR 0.86; 95% CI 0.63 to 1.17; Heterogeneity: Tau² =

    0.15; I² = 49%), or other reported clinical outcomes.

     Authors’ conclusions

    Caesarean section is a common procedure performed on women worldwide. There is increasing evidence that for many techniques,

    short-term maternal outcomes are equivalent. Until long-term health effects are known, surgeons should continue to use the techniques

    they prefer and currently use.

    P L A I N L A N G U A G E S U M M A R Y

    Surgical techniques involving the uterus at caesarean section

    Caesarean section is a common abdominal operation for surgical delivery of a baby and the placenta. Techniques vary depending 

    on the clinical situation and surgeon preferences. Safe delivery is important for mother and infant. Any potential reduction of birth

    trauma to the infant has to be balanced against increased ill-health for the mother. Factors include not only the duration of the surgical

    procedure and maternal blood loss but also maternal postoperative pain, continuing blood loss and development of anaemia, fever and

     wound infection. Additional complications can include problems with breastfeeding, passing urine, longer-term fertility problems, and

    complications in future pregnancies (uterine rupture) or increased risks associated with future surgery.

    The review authors searched the medical literature for randomised controlled trials to inform the most appropriate surgical techniques

    to use. Twenty-seven trials involving 17,808 women from a number of different countries contributed to the review. None of these

    trials assessed the type of uterine incision (side to side (transverse) lower uterine segment incision versus other types of uterine incision).

    Results from 18 randomised trials contributed to reports that single layer closure of the uterine incision was associated with a reductionin blood loss, and duration of the procedure. In these studies the surgical procedure for entering the abdominal cavity also differed and

    could have contributed to blood loss and duration of surgery.

    Five trials compared blunt with sharp dissection at the time of the uterine incision (2141 women) and a further two trials auto-suture

    devices with standard hysterotomy (300 women). Blunt surgery was associated with a reduction in mean blood loss at the time of 

    the procedure. The use of an auto-suture instrument did not clearly reduce procedural blood loss but increased the duration of the

    procedure. Overall, trials focused on blood loss and duration of the operative procedure rather than clinical outcomes for the women.

    The methodological quality of the trials was variable.

    2Surgical techniques for uterine incision and uterine closure at the time of caesarean section (Review)

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    B A C K G R O U N D

    Description of the condition

    Caesarean section is a common major operation performed on

     women in the world. Essentially, the operation involves exposing 

    the uterus by entering the abdominal cavity through the abdom-

    inal wall. The peritoneal lining of the abdomen is opened and

    the peritoneum covering the uterus is usually also entered. The

    bladder is reflected away from the uterus to reduce the chance of 

    damage to it during the operation. The uterus is then incised and

    the baby and placenta delivered. Adequate haemostasis (control of 

    bleeding) is achieved by closure of the uterine muscle, followed by 

    closure of the abdominal wall.

    Description of the intervention

    There are many possible ways of performing a caesarean section

    operation, and operative techniques vary widely. The techniques

    used may depend on many factors, including the clinical situa-

    tion and the preferences of the operator. Another Cochrane re-

    view providing an overview of the techniques, indications for cae-

    sarean section and postoperative complications, has been pub-

    lished (Hofmeyr 2008).

    Our review specifically assessed surgical techniques involving the

    uterus at the time at caesarean section, and included:

    1. the type of uterine incision (lower transverse uterine

    incision versus other types of uterine incision);

    2. methods of performing the uterine incision (’sharp’ uterine

    entry versus ’blunt’ uterine entry);

    3. suturing materials and techniques for the uterus at

    caesarean section; and

    4. single versus double layer suturing for closing the uterine

    incision at caesarean section.

    How the intervention might work 

    Part one: type of uterine incision at caesarean section

    Part one of thisreview comparesthe outcomes of caesarean sections

    performed using a transverse lower segment uterine incision with

    other types of uterine incision (low vertical, ’classical’, T-shaped

    or J-shaped incision).

    The transverse (side-to-side) lower segment uterine incision is

     widely used in obstetric practice today. This incision has been

    favoured because the lower uterine segment is less vascular than

    the body of the uterus, and the incision is easier to repair. This

    leadsto a reduction in operativecomplications, especially haemor-

    rhage, and also a reduction in morbidity. Lower segment incisions

    are also associated with a lower incidence of uterine dehiscence or

    rupture in subsequent pregnancies (Tahilramaney 1984).

    The use of a low vertical uterine incision has been recommended

    in certain clinical situations, particularly in delivery of the preterm

    infant, where the lower uterine segment may be poorly formed

    and the longitudinal incision may facilitate delivery and reducebirth trauma by improved surgical access.

     A ’classical’ uterine incision involves a vertical (up and down cut)

    in the upper body of the uterus, and is used more rarely. It may be

    used when the baby is in a transverse lie (that is, lying across the

    mother’s uterus), when the infant is preterm, or if there is an ante-

    rior placenta praevia (the placenta lies in the lower segment andon

    the front wall of the uterus where the lower transverse uterine in-

    cision is usually made), but in practice, this incision is rarely used.

    Haemorrhage is potentially more severe when an upper uterine

    segment incision is used, and the repair often requires closure in

    three layers as the myometrium (uterine muscle) is thicker in this

    part of the uterus.

    Occasionally, a transverse lower segment incision is made, andduring the operation, the incision needsto be extended in order to

    obtain better surgical access, or to facilitate delivery of the infant.

    In these situations, the incision may be extended vertically in the

    midline, into the upper segment of the uterus forming an inverted

    (upside-down) T-shaped incision. Alternatively, the incision may 

    be extended vertically from the end of the transverse incision to

    form a J-shaped incision.

    Potential injuries that may occur for the infant during a traumatic

    caesarean birth include fractures, peripheral nerve damage, spinal

    cord injury and subdural haematoma. Any potential reduction of 

    birth trauma to the infant has to be balanced against potential in-

    creased morbidity to the mother such as operative blood loss and

    postoperative complications. In particular, consideration needs tobe given to mode of birth in any subsequent pregnancy. Uterine

    rupture is a significant risk in a subsequent pregnancy or labour,

     with estimates of occurrence being 4% to 9% for classical (uter-

    ine body, midline) caesarean incision; 4% to 9% for inverted T-

    shaped incisions; 1% to 7% for lower uterine segment vertical in-

    cisions; and 0.2% to 1.5% for lower uterine segment transverse

    incisions ( ACOG 1999). Current ACOG guidelines limit trial of 

    vaginal birth after caesarean section to women with a lower uter-

    ine segment transverse incision, and recommend repeat caesarean

    birth forwomen with a prior classicalor inverted T-shaped uterine

    scar ( ACOG 1999). Any consideration of the benefits associated

     with a particular uterine incision must also consider the longer-

    term risks associated with repeat caesarean.

    Part two: methods of performing the uterine incision

    Part two of this review compares the outcomes of caesarean sec-

    tions performed using different methods of incising the uterus

    (including autostapling and sharp and blunt uterine entry).

     When the uterus is incised at the time of caesarean section, the in-

    cisionmay be made in the centreof the lower uterine segment with

    3Surgical techniques for uterine incision and uterine closure at the time of caesarean section (Review)

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    a scalpel and then extended laterally with scissors (’sharp’ uterine

    entry) or by digital extension (using the fingers) (’blunt’ uterine

    entry). There has been ongoing debate about which of these forms

    of entry results in better maternal and infant outcomes (Rodriguez

    1994). Theoretical benefits of sharp uterine entry include more

    rapid delivery of the baby, and a more controlled entry, with lesslikelihood of the incision extending into the broad ligament or

    uterine vessels. The ’clean’ incision may also be easier to repair.

    Proponents of blunt uterine entry argue that following the tissue

    planes reduces blood loss and improves healing, and that dispens-

    ing with an instrument improves control over the entry.

     Autostapling techniques involve the insertion of staples as the

    surgical incision is made in order to keep the operating field as

    bloodless as possible ( Wilkinson 2006). The Auto Suture Poly 

    CS 57 Stapler was developed in the early 1990s. Its aim was to

    achieve haemostasis through the placement of a double layer of 

    absorbable sutures before the uterine incision was made. The tech-

    nique may be useful in particular circumstances, for example,

     where the woman is infected with HIV, reducing contamination with maternal blood and potentially reducing viral transmission

    to the infant.

    Part three: suturing materials and techniques for the

    uterus

    Part three of this review compares the outcomes of caesarean sec-

    tions performed using different materials and techniques for clo-

    sure of the uterine incision.

    There are a range of suture materials and techniques used in sur-

    gical procedures, with the choice often resting with the preference

    of the operator. For example, some advocate a single continuous

    suture to close the uterus, which can be locked or not locked.

    Others advocate multiple or interrupted sutures. Depending on

    local resources and preference, different types of suture includ-

    ing monofilament and polyfilament/multifilament may be used to

    close the uterus.

    Part four: single versus double layer suturing for 

    closing the uterine incision

    Part four of this review compares the outcomes of caesarean sec-

    tions performed using single layer closure of the uterine incision

     with those using double layer closure.

    One specific question about the technique used for uterine closure

    is whetherit should be closedwith one layer of sutures or two. Tra-

    ditionally, the transverse lower segment uterine incision is closed

    in two layers (Enkin 2006). Those who advocate double closure

    of the uterus cite improved haemostasis and wound healing, and

    possibly a reduced risk of uterine rupture in a subsequent preg-

    nancy. Single layer closure may be associated with reduced oper-

    ating time, less tissue disruption, and less introduction of foreign

    suture material into the wound. These potential advantages may 

    translate into reduced operative and postoperative morbidity for

     women. However, a recent observational study from Canada has

    suggested that single layer closure of the lower uterine segment

    at caesarean section is associated with a four-fold increase in the

    risk of uterine rupture in a subsequent pregnancy when compared

     with double layer uterine closure (odds ratio 3.95, 95% confidence

    interval 1.35 to 11.49) (Bujold 2002).

     Why it is important to do this review

    Caesarean section is a common operation, with many different

    methods of performing the surgery. It is important to assess the

    benefits and harms associated with these different ways of per-

    forming the surgery.

    O B J E C T I V E S

    To compare, using the best available evidence, the effects of:

    1. different types of uterine incision;

    2. different methods of performing the uterine incision;

    3. different materials and techniques for closure of the uterine

    incision; and

    4. single versus double layer closure of the uterine incision on

    maternal or infant health, or both, and health care resource use.

    M E T H O D S

    Criteria for considering studies for this review

    Types of studies

     All published, unpublished, and ongoing randomised controlled

    trials comparing various types of uterine incision and closure of 

    the uterine incision during caesarean section.

     We excluded quasi-randomised trials (e.g. those randomised by 

    date of birth or hospital number) from the analysis. Studies pre-sented in abstract form only will not be included until the full

    report becomes available to assess methodological quality and rel-

    evance to the scope of the review.

    Types of participants

     Women undergoing caesarean birth.

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    Types of interventions

    1. Transverse lower uterine segment incision versus other types

    of uterine incision.

    2. Methods of performing the uterine incision (including 

    ’sharp’ versus ’blunt’ uterine entry; absorbable sutures versus

    scissor or digital extension; direction of dissection (transverseversus cephalad-caudad)).

    3. Different materials or techniques, or both, for closure of the

    uterine incision (including continuous suture versus interrupted

    suture).

    4. Single versus double layer closure of the uterine incision.

    Types of outcome measures

    Primary outcomes

    Postoperative febrile morbidity (as defined by trial authors).

    Secondary outcomes

    Outcome measures for the woman

    1. Postoperative analgesia requirements (as defined by trial

    authors).

    2. Blood loss (as defined by trial authors).

    3. Maternal death or serious maternal morbidity (e.g.

    admission to intensive care unit).

    4. Need for blood transfusion.5. Wound infection (as defined by trial authors).

    6. Wound complications (e.g. operative procedures carried out

    on the wound; wound haematoma).

    7. Postoperative pain (as measured by visual analogue scale or

    need for additional analgesia).

    8. Breastfeeding (at hospital discharge, or as defined by trial

    authors).

    9. Voiding problems (as defined by trial authors).

    10. Duration of surgery.

    11. Postoperative anaemia (as defined by trial authors).

    12. Thromboembolic disease.

    13. Complications during the postoperative period requiring 

    further surgery (re-laparotomy).

    Longer-term outcome measures for the woman

    1. Future fertility problems.

    2. Complications in a future pregnancy (e.g. placenta praevia,

    placenta accreta, uterine rupture).

    3. Complications at future surgery (e.g. adhesion formation).

    Outcome measures for the infant (applicable to part one and

    two of the review)

    1. Neonatal death.

    2. Birth trauma (as defined by trial authors).

    3. Infant laceration.

    4. Admission to neonatal intensive care unit and length of stay.

    Health service use

    1. Length of postoperative stay for the woman and infant.

    2. Readmission to hospital of the woman or infant, or both.

    Only outcomes with available data appear in the analysis table.

    Only outcome data that were prestated by the review authors have

    been used.

    The methods section of this review is based on a standard template

    used by the Cochrane Pregnancy and Chilbirth Group.

    Search methods for identification of studies

    Electronic searches

     We searched the Cochrane Pregnancy and Childbirth Group’s

    Trials Register by contacting the Trials Search Co-ordinator (1

    September 2013).

    The Cochrane Pregnancy and Childbirth Group’s Trials Register

    is maintained by the Trials Search Co-ordinator and contains trials

    identified from:

    1. monthly searches of the Cochrane Central Register of 

    Controlled Trials (CENTRAL);

    2. weekly searches of MEDLINE;

    3. weekly searches of Embase;4. handsearches of 30 journals and the proceedings of major

    conferences;

    5. weekly current awareness alerts for a further 44 journals

    plus monthly BioMed Central email alerts.

    Details of the search strategies for CENTRAL, MEDLINE and

    Embase, the list of handsearched journals and conference pro-

    ceedings, and the list of journals reviewed via the current aware-

    ness service can be found in the ‘Specialized Register’ section

     within the editorial information about the  Cochrane Pregnancy 

    and Childbirth Group.

    Trials identified through the searching activities described above

    are each assigned to a review topic (or topics). The Trials Search

    Co-ordinator searches the register for each review using the topic

    list rather than keywords.

    Searching other resources

     We conducted a manual search of the reference lists of all identified

    papers.

     We did not apply any language restrictions.

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    Data collection and analysis

    For the methods used when assessing the trials identified in the

    previous version of this review, see  Appendix 1.For this update we used the following methods when assessing the

    reports identified by the updated search.

    Selection of studies

    Two review authors independently assessed for inclusion all the

    potential studies we identified as a result of the search strategy. We

    resolved any disagreement through discussion or, if required, we

    consulted a third person.

    Data extraction and management

     We designed a form to extract data. For eligible studies, two review 

    authors extracted the data using the agreed form. We resolved

    discrepancies through discussion or, if required, we consulted a 

    third person. We entered data into Review Manager software (RevMan 2012) and checked it for accuracy.

     When information regarding any of the above was unclear, we

    planned to contact authors of the original reports to provide fur-

    ther details.

    Assessment of risk of bias in included studies

    Two review authors independently assessed risk of bias for each

    study using the criteria outlined in the  Cochrane Handbook for Systematic Reviews of Interventions ( Higgins 2011 ).  We resolvedany disagreement by discussion or by involving a third assessor.

    (1) Random sequence generation (checking for possible

    selection bias)

     We described for each included study the method used to generate

    the allocation sequence in sufficient detail to allow an assessment

    of whether it should produce comparable groups.

     We assessed the method as:

    •  low risk of bias (any truly random process, e.g. random

    number table; computer random number generator);

    •  high risk of bias (any non-random process, e.g. odd or even

    date of birth; hospital or clinic record number);

    •  unclear risk of bias.

    (2) Allocation concealment (checking for possible selectionbias)

     We described for each included study the method used to con-

    ceal allocation to interventions prior to assignment and assessed

     whether intervention allocation could have been foreseen in ad-

    vance of, or during recruitment, or changed after assignment.

     We assessed the methods as:

    •  low risk of bias (e.g. telephone or central randomisation;

    consecutively numbered sealed opaque envelopes);

    •  high risk of bias (open random allocation; unsealed or non-

    opaque envelopes, alternation; date of birth);

    •  unclear risk of bias.

    (3.1) Blinding of participants and personnel (checking for 

    possible performance bias)

     We described for each included study the methods used, if any, to

    blind study participants and personnel from knowledge of which

    intervention a participant received. We considered that studies

     were at low risk of bias if they were blinded, or if we judged that the

    lack of blinding was unlikely to affectresults. We assessed blinding 

    separately for different outcomes or classes of outcomes.

     We assessed the methods as:

    •  low, high or unclear risk of bias for participants;

    •  low, high or unclear risk of bias for personnel.

    (3.2) Blinding of outcome assessment (checking for possible

    detection bias)

     We described for each included study the methods used, if any, to

    blind outcome assessors from knowledge of which intervention a 

    participant received. We assessed blinding separately for different

    outcomes or classes of outcomes.

     We assessed methods used to blind outcome assessment as:

    •  low, high or unclear risk of bias.

    (4) Incomplete outcome data (checking for possible attritionbias due to the amount, nature and handling of incomplete

    outcome data)

     We described for each included study, and for each outcome or

    class of outcomes, the completeness of data including attrition and

    exclusions from the analysis. We stated whether attrition and ex-

    clusions were reported and the numbers included in the analysis at

    each stage (compared with the total randomised participants), rea-

    sons for attrition or exclusion where reported, and whether miss-

    ing data were balanced across groups or were related to outcomes.

     Where sufficient information was reported, or could be supplied

    by the trial authors, we planned to re-include missing data in the

    analyses which we undertook.

     We assessed methods as:

    •  low risk of bias (e.g. no missing outcome data; missing 

    outcome data balanced across groups);

    •  high risk of bias (e.g. numbers or reasons for missing data 

    imbalanced across groups; ‘as treated’ analysis done with

    substantial departure of intervention received from that assigned

    at randomisation);

    •  unclear risk of bias.

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    (5) Selective reporting (checking for reporting bias)

     We described for each included study how we investigated the

    possibility of selective outcome reporting bias and what we found.

     We assessed the methods as:

    •  low risk of bias (where it is clear that all of the study’s pre-

    specified outcomes and all expected outcomes of interest to thereview have been reported);

    •  high risk of bias (where not all the study’s pre-specified

    outcomes have been reported; one or more reported primary 

    outcomes were not pre-specified; outcomes of interest are

    reported incompletely and so cannot be used; study fails to

    include results of a key outcome that would have been expected

    to have been reported);

    •  unclear risk of bias.

    (6) Other bias (checking for bias due to problems not

    covered by (1) to (5) above)

     We described for each included study any important concerns wehad about other possible sources of bias.

     We assessed whether each study was free of other problems that

    could put it at risk of bias:

    •  low risk of other bias;

    •  high risk of other bias;

    •  unclear whether there is risk of other bias.

    (7) Overall risk of bias

     We made explicit judgements about whether studies were at high

    risk of bias, according to the criteria given in the  Handbook 

    (Higgins 2011). With referenceto (1) to (6) above, we assessed thelikely magnitude and direction of the bias and whether we consid-

    ered it likely to impact on the findings. We planned to explore the

    impact of the level of bias through undertaking sensitivity analyses

    - see  Sensitivity analysis.

    Measures of treatment effect

    Dichotomous data

    For dichotomous data, we presented results as summary risk ratio

     with 95% confidence intervals.

    Continuous data

    For continuous data, we used the mean difference if outcomes

     were measured in the same way between trials. In future updates,

    if appropriate, we will use the standardised mean difference to

    combine trials that measure the same outcome, but use different

    methods.

    Unit of analysis issues

    Cluster-randomised trials

     We planned to include cluster-randomised trials in the analyses

    along with individually-randomised trials. No cluster-randomised

    trials were identified for this update. In future updates, if identi-

    fied and analysed, we will adjust their sample sizes using the meth-

    ods described in the Handbook  [Section 16.3.4] using an estimateof the intracluster correlation co-efficient (ICC) derived from the

    trial (if possible), from a similar trial or from a study of a similar

    population. If we use ICCs from other sources, we will report this

    and conduct sensitivity analyses to investigate the effect of varia-

    tion in the ICC. If we identify both cluster-randomised trials and

    individually-randomised trials, we plan to synthesise the relevant

    information. We will consider it reasonable to combine the re-

    sults from both if there is little heterogeneity between the study 

    designs and the interaction between the effect of intervention andthe choice of randomisation unit is considered to be unlikely.

     We will also acknowledge heterogeneity in the randomisation unit

    and perform a sensitivity analysis to investigate the effects of the

    randomisation unit.

    Cross-over trials

    Cross-over trials are not an appropriate study design for the inter-

    ventions considered in this review.

    Dealing with missing data

    For included studies, we noted levels of attrition. We planned to

    explore the impact of including studies with high levels of missing 

    data in the overall assessment of treatment effect by using sensi-

    tivity analysis.

    For all outcomes, we carried out analyses, as far as possible, on

    an intention-to-treat basis, i.e. we attempted to include all partic-

    ipants randomised to each group in the analyses, and all partici-

    pants were analysed in the group to which they were allocated, re-

    gardless of whetheror not theyreceivedthe allocatedintervention.

    The denominator for each outcome in each trial was the number

    randomised minus any participants whose outcomes were known

    to be missing.

    Assessment of heterogeneity

     We assessed statistical heterogeneity in each meta-analysis using 

    the Tau², I² and Chi² statistics. We regarded heterogeneity as sub-

    stantial if an I² was greater than 30% and either a Tau² was greater

    than zero, or there was a low P value (less than 0.10) in the Chi²

    test for heterogeneity.

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    Assessment of reporting biases

    For this update, there were not more than 10 studies in any meta-

    analysis. In future updates, if there are 10 or more studies in the

    meta-analysis, we will investigate reporting biases (such as publica-

    tion bias) using funnel plots. We will assess funnel plot asymmetry 

    visually. If asymmetry is suggested by a visual assessment, we willperform exploratory analyses to investigate it.

    Data synthesis

     We carried out statistical analysis using the Review Manager soft-

     ware (RevMan 2012). We used fixed-effect meta-analysis for com-

    bining data where it was reasonable to assume that studies were

    estimating the same underlying treatment effect: i.e. where trials

     were examining the same intervention, and the trials’ populations

    and methods were judged sufficiently similar. If there was clinical

    heterogeneity sufficient to expect that the underlying treatment ef-

    fects differed between trials, or if substantial statistical heterogene-

    ity was detected, we used random-effects meta-analysis to producean overall summary, if an average treatment effect across trials was

    considered clinically meaningful. The random-effects summary 

     was treated as the average range of possible treatment effects and

     we discussed the clinical implications of treatment effects differing 

    between trials. If the average treatment effect was not clinically 

    meaningful, we did not combine trials.

    If we used random-effects analyses, the results were presented as

    the average treatment effect with 95% confidence intervals, and

    the estimates of Tau² and I².

    Subgroup analysis and investigation of heterogeneity

     We did not carry out subgroup analysis for this update.

    In future updates, if we identify substantial heterogeneity, we will

    investigate it using subgroup analyses and sensitivity analyses. We

     will consider whether an overall summary is meaningful, and if it

    is, use random-effects analysis to produce it.

     We plan to carry out the following subgroup analyses.

    1. Planned (elective procedure, not in labour) versus

    emergency procedures (procedures performed in labour,

    including those women that had intended an ’elective operation“

    and now in spontaneous labour).

    2. Primary versus subsequent caesarean section procedure.

    Only the primary outcome will be used in subgroup analysis.

     We will assess subgroup differences by interaction tests available

     within RevMan (RevMan 2012). We will report the results of subgroup analyses quoting the Chi² statistic and P value, and the

    interaction test I² value.

    Sensitivity analysis

     We planned to carry out sensitivity analyses to explore the effect of 

    trial quality assessed by concealment of allocation, high attrition

    rates (greater than 20%), or both, with poor-quality studies being 

    excluded from the analyses in order to assess whether this made

    any difference to the overall result.

    R E S U L T S

    Description of studies

    Results of the search

    The search strategy identified 60 studies for consideration in this

    review.

    Included studies

    Twenty-seven randomised controlled trials, involving 17,808

     women undergoing caesarean section were included in this re-view (Batioglu 1998;   Bjorklund 2000;   CAESAR 2010;   Ceci

    2012; CORONIS 2013; Chitra 2004; Cromi 2008; Dani 1998;

    Darj 1999; Ferrari 2001; Gutierrez 2008; Hamar 2007; Hauth

    1992;   Hidar 2007;   Lal 1988;   Magann 2002;   Moreira 2002;

    Poonam 2006;   Rodriguez 1994;   Sekhavat 2010;   Sood 2005;

    Studzinski 2002; Villeneuve 1990; Von Rechenberg 1990; Wallin

    1999; Xavier 2005; Yasmin 2011). Information related to longer-

    term follow-up of women was available from the Hauth paper

    (Chapman 1997) for the Hauth 1992 trial.

    Types of uterine incision (transverse lower uterine segment

    incision versus other types of uterine incision)

    There were no studies identified making this comparison in rela-

    tion to type of uterine incision.

    Methods of performing the uterine incision (including ’sharp’

    versus ’blunt’ uterine entry; absorbable sutures versus

    scissor or digital extension; direction of blunt dissection:

    transverse versus cephalad-caudad)

    Five studies were included in the review making the comparison

    between methods of performing the uterine incision (Hidar 2007;

    Magann 2002; Poonam 2006; Rodriguez 1994; Sekhavat 2010).

     All compared blunt versus sharp dissection at the time of uter-

    ine incision, involving women from the United States (Magann

    2002; Rodriguez 1994), Tunisia (Hidar 2007), Nepal (Poonam

    2006), and Iran (Sekhavat 2010). Two studies were identified in-

    volving the use of the Autosuture Poly CS 57 automatic surgical

    stapler compared with standard hysterotomy, involving women

    fromCanada(Villeneuve 1990) andSwitzerland (Von Rechenberg 

    1990). A singlestudy compared thedirection of blunt extension of 

    the uterine incision (transverse versus cephalad-caudad), involving 

     women from Italy (Cromi 2008). All studies were single centre.

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    Different materials or techniques, or both, for closure of the

    uterine incision (including continuous suture versus

    interrupted suture)

    One study was identified that compared continuous suture closure

     with interrupted suture closure of the uterine incision(Ceci 2012).

     Women were followed until 24 months postpartum but only ul-trasound and hysteroscopic assessments were reported. One study 

     was identified that compared two different types of material for

    closure of the uterine incision (CORONIS 2013). In this study,

    chromic catgut was compared with number 1 polygactin-910 in

    almost 10,000 women (this closure could be with interrupted or

    continuous sutures).

    Single versus double layer closure of the uterine incision

    Nineteen studies were identified comparing single layer with dou-

    ble layer closure of the uterus (Batioglu 1998; Bjorklund 2000;

    CAESAR 2010; CORONIS 2013; Chitra 2004; Dani 1998; Darj

    1999; Ferrari 2001; Gutierrez 2008; Hamar 2007; Hauth 1992;Lal 1988; Moreira 2002; Poonam 2006; Sood 2005;  Studzinski

    2002; Wallin 1999;  Yasmin 2011; Xavier 2005). These studies

     were conducted in Tanzania (Bjorklund 2000), Tunisia (Hidar

    2007), Senegal (Moreira 2002), the United Kingdom (CAESAR 

    2010), United States of America (Hamar 2007; Hauth 1992), In-

    dia (Chitra 2004; Lal 1988; Sood 2005), Nepal (Poonam 2006),

    Mexico(Gutierrez 2008), Turkey(Batioglu1998),Italy(CAESAR 

    2010; Dani 1998; Ferrari 2001), Poland (Studzinski 2002), Sene-

    gal (Moreira 2002), Portugal ( Xavier 2005), and Sweden (Darj

    1999; Wallin 1999). With the exception of the CAESAR study 

    (CAESAR 2010), and the CORONIS study (CORONIS 2013),

    allwere singlecentre. The study by Yasmin andcolleagues ( Yasmin

    2011) focused on ultrasound follow-up of the uterine scar, out-comes which were not pre-specified in this review. The study by 

    Dani and colleagues (Dani 1998) reported short-term infant out-

    comes after caesarean section, but none of these outcomes were

    prespecified in the review.

    For details of the included studies, see the table of  Characteristics

    of included studies.

    Excluded studies

    Twenty-six studies were excluded from the review, with 14

    studies using quasi-randomised methods of treatment allocation

    ( Ansaloni 2001;   Baxter 2008;   Behrens 1997;   Dargent 1990;

    Falls 1958; Gaucherand 2001; Hameed 2004; Heidenreich 1995;

    Hoskins 1991;  Kiefer 2008;   Lodh 2002;   Ohel 1996;  Redlich

    2001; Van Dongen 1989; ). Eleven studies were excluded as thecomparisons did not involve surgical techniques on the uterus

    (Buhimschi 2006;   Decavalas 1997;   Doganay 2010;  Gedikbasi

    2011;   Ghezzi 2001;   Giacalone 2002;   Hohlagschwandtner;

    Malvasi 2011; Moroz 2008; Naki 2011; Ozbay 2011). One study 

    did not utilise intention-to-treat principles for data analysis, and

    it was not possible from the information provided to restore par-

    ticipants to their randomised groups (Heimann 2000).

    For details of the excluded studies, see the table of  Characteristics

    of excluded studies.

    Studies awaiting assessment and ongoing studies

    Several reports were identified in abstract form only, with in-

    sufficient information available to allow assessment for inclu-

    sion in this review (Borowski 2007; Hagen 1999; Mazhar 2004;

    Mukhopadhyay 2000; Pandey 2006; Wojdemann 2010); another

    trial report is in Polish and is awaiting translation (Belci 2005)

    (see Studies awaiting classification), In addition, we identified one

    trial registration (Farajzadeh 2010) (see Characteristics of ongoing 

    studies).

    Risk of bias in included studies

    Overall, the methodological quality of the trials was variable (see

    Description of studies  and  Characteristics of included studies).

    There was variable reporting of the prespecified outcomes of thereview, with 21 trials presenting information that could be incor-

    porated into the meta-analysis (Batioglu 1998; Bjorklund 2000;

    CAESAR 2010;  CORONIS 2013;   Chitra 2004; Cromi 2008;

    Ferrari 2001; Gutierrez 2008; Hamar 2007; Hauth 1992; Hidar

    2007; Magann 2002; Moreira 2002; Poonam 2006; Rodriguez

    1994;   Sekhavat 2010;   Studzinski 2002;   Villeneuve 1990;   Von

    Rechenberg 1990; Wallin 1999; Xavier 2005).

    See  Figure 1; and Figure 2 for a summary of ’Risk of bias’ assess-ments.

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    Figure 1. ’Risk of bias’ graph: review authors’ judgements about each risk of bias item presented as

    percentages across all included studies.

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    Figure 2. ’Risk of bias’ summary: review authors’ judgements about each risk of bias item for each included

    study.

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    Allocation

     While all of the studies were stated to be randomised, the method

    of randomisation was adequately described in 13 trials as involv-

    ing either computer-generated randomisation sequences or ta-

    bles of random numbers (Bjorklund 2000; CAESAR 2010; Ceci

    2012; CORONIS 2013; Cromi 2008; Hauth 1992; Hidar 2007;

    Magann 2002;  Sekhavat 2010;   Sood 2005;   Villeneuve 1990;

     Wallin 1999; Xavier 2005). The methodof allocation concealment

     was assessed as adequate in 13 trials, with 11 utilising sequentially 

    numbered, sealed, opaque envelopes (Bjorklund 2000; Darj1999;

    Ferrari 2001; Hamar 2007; Hauth 1992; Hidar 2007; Magann

    2002; Sekhavat 2010; Sood 2005; Villeneuve 1990; Wallin 1999),

    and two telephone randomisation (CAESAR 2010; CORONIS

    2013).

    BlindingBlinding of outcome assessor was indicated in only six of the trials

    (CAESAR 2010; Ceci 2012; Dani 1998; Sood 2005; Wallin 1999;

     Xavier 2005). Blinding of both participants andpersonnel wasnot

    indicated in any of the included trials. Participants were blinded

    in one trial (Sekhavat 2010).

    Incomplete outcome data

    Most included studies were assessed as at low risk of bias due to

    incomplete outcome data, withthreebeing assessed as unclear risk.

    Selective reporting

    Most included studies were assessed as at low risk of bias for se-

    lective reporting, however, four studies were assessed as having an

    unclear risk of selective reporting bias.

    Other potential sources of bias

    The CEASAR trial was identified as at potential risk of bias, hav-

    ing modified the primary outcome of the trial after 600 women

     were recruited, and as the trial was stopped short of the total es-

    timated sample size (CAESAR 2010). The trial by Xavier ( Xavier

    2005) recruited and randomised 162 women, with outcome data 

    reported for only 72.

    Effects of interventions

    Twenty-seven randomised controlled trials, involving 17,808

     women undergoing caesarean section were included in this review,

    as described below.

    Methods of performing the uterine incision (including

    ’sharp’ versus ’blunt’ uterine entry and absorbable

    sutures versus scissor or digital extension)

    Automatic stapler versus conventional uterine incision

    Two trials (Villeneuve 1990; Von Rechenberg 1990) compared

    auto-suture devices with traditional hysterotomy involving 300

     women. It was only possible to combine data from the two trials

    included for the primary outcome, febrile morbidity. No statisti-

    cally significant difference between the stapler and conventional

    incision groups was apparent (risk ratio (RR) 0.92, 95% confi-

    dence interval (CI) 0.38 to 2.20),  Analysis 1.1. Other outcomes

    included data from only one study. There is a suggestion of a lower

    blood loss in the stapler group in Villeneuve 1990 (mean differ-

    ence (MD) -87.00 mL, 95% CI -175.09 to 1.09), Analysis 1.2;

    however, the lack of blinding means that bias in the assessment of this outcome cannot be excluded.

    Blunt versus sharp extension of the uterine incision

    Five trials compared blunt with sharp extension of the uterine inci-

    sion,involving2141women( Hidar 2007; Magann 2002; Poonam

    2006; Rodriguez 1994; Sekhavat 2010). Therewere no statistically 

    significant differences identified for the primary outcome febrile

    morbidity following blunt or sharp extension of the uterine inci-

    sion (four studies; 1941 women; RR 0.86; 95% CI 0.70 to 1.05),

     Analysis 2.1. Mean blood loss (two studies; 1145 women; aver-

    age MD -55.00 mL; 95% CI -79.48 to -30.52; Heterogeneity:

    Tau² = 160.80; I² = 51%),  Analysis 2.2, and the need for bloodtransfusion (two studies; 1345 women; RR 0.24; 95% CI 0.09 to

    0.62), Analysis 2.3, were significantly lower following blunt ex-

    tension, with no other significant differences identified in dura-

    tion of operative procedure (one study; 200 women; MD -2.80

    minutes; 95% CI -5.84 to 0.24), Analysis 2.5, or risk of serious

    maternal morbidity (one study; 400 women; RR 3.00; 95% CI

    0.12 to 73.20), Analysis 2.4.

    Direction of blunt extension of the uterine incision:

    transverse versus cephalad-caudad

     A single trial compared transverse with cephalad-caudad blunt

    extension of the uterine incision, involving 811 women (Cromi2008). While mean blood loss was reported to be lower following 

    transverse extension (one study; 811 women; MD 42.00 mL; 95%

    CI 1.31 to 82.69),  Analysis 3.1, the clinical significance of such

    a small volume difference is of uncertain clinical relevance. There

     were no other statistically significant differences identified for the

    limited outcomes reported.

    12Surgical techniques for uterine incision and uterine closure at the time of caesarean section (Review)

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    of allocation concealment, and only six trials indicating blinding 

    of outcome assessors.

    Agreements and disagreements with other 

    studies or reviewsThe literature describing and assessing caesarean section surgical

    techniques is broad and in general of low quality, and as such the

    current review is in general agreement with most other studies and

    reviews in this area.

    A U T H O R S ’ C O N C L U S I O N S

    Implications for practice

    Despite caesarean section being a common operation, for many 

    aspects of the procedure, there is limited high quality information

    available to suggest that one surgical technique is superior to an-

    other. There is no information available to inform the most ap-

    propriate uterine incision. There is little information to support

    the most appropriate method of performing the uterine incision

    (blunt versus sharp dissection) or to support the use of an auto-

    suture device. There is limited information available to inform

    the optimal suture technique for the uterine incision. Consider-

    ation should be given to suture material for uterine closure, as

    closure with chromic catgut was associated with a lower risk of 

    blood transfusion, when compared with polygactin-910, with no

    difference in other clinical outcomes.

    Caesarean section is a common procedure performed on women

     worldwide. There is increasing evidence that for many techniques,

    short-term maternal outcomes are equivalent. Until long-term

    health effects areknown, surgeons shouldcontinueto usethe tech-

    niques they prefer and currently use.

    Implications for research

    Future randomised controlled trials and future follow-up of 

     women in existing trials should address:

    •  the most appropriate uterine incision;

    •  the optimal suture technique to close the uterus;

    •  the value of blunt compared with sharp uterine dissection;

    and

    •  the value of single compared with double layer uterine

    closure.

     Any future randomised trials should be adequately powered to

    detect important differences in clinically relevant outcomes.

    A C K N O W L E D G E M E N T S

     As part of the pre-publication editorial process, this review has

    been commented on by six peers (an editor and five referees who

    are external to the editorial team), a member of the Pregnancy 

    and Childbirth Group’s international panel of consumers and a 

    statistician.

    R E F E R E N C E S

    References to studies included in this review 

    Batioglu 1998  {published data only}

    Batioglu S, Kuscu E, Duran EH, Haberal A. One-layer

    closure of low segment transverse uterine incision by the

    Lembert technique.  Journal of Gynecologic Surgery  1998;14:

    11–4.

    Bjorklund 2000  {published data only}

    Bjorklund K, Kimaro M, Urassa E, Lindmark G.

    Introduction of the Misgav Ladach caesarean section at

    an African tertiary centre: a randomised controlled trial.

    British Journal of Obstetrics and Gynaecology  2000;107(2):209–16.

    CAESAR 2010  {published data only}

    Brocklehurst P. The CAESAR study: a randomised

    controlled trial of caesarean section surgical techniques

    [abstract]. 31st British International Congress of Obstetrics

    and Gynaecology; 2007 July 4-6; London, UK. 2007:31.∗ CAESAR study collaborative group. Caesarean section

    surgical techniques: a randomised factorial trial (CAESAR).

    BJOG: an international journal of obstetrics and gynaecology 

    2010;117(11):1366–76.

    National Perinatal Epidemiology Unit. The CAESAR 

    Study. www.npeu.ok.ac.uk/trials/caesar.html (accessed

    2001).

    Ceci 2012  {published data only}

    Ceci O, Cantatore C, Scioscia M, Nardelli C, Ravi M,

    Vimercati A, et al.Ultrasonographic and hysteroscopic

    outcomes of uterine scar healing after cesarean section:

    comparison of two types of single-layer suture.  Journal of  

    Obstetrics and Gynaecology Research 2012;38(11):1302–7.

    Chitra 2004  {published data only}

    Chitra KLS, Nirmala AP, Gayetri R, Jayanthi NV, Shanthi

     JS. Misgav Ladach cesarean section vs Pfannenstiel cesarean

    section. Journal of Obstetrics and Gynecology of India  2004;

    54(5):473–7.

    14Surgical techniques for uterine incision and uterine closure at the time of caesarean section (Review)

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    CORONIS 2013  {published data only}

    Brocklehurst P, for the CORONIS Trial Collaborative

    Group. The CORONIS Trial: International study of 

    caesarean section surgical techniques: a randomised

    fractional factorial randomised trial.  BJOG: an international 

     journal of obstetrics and g ynaecology  2013;120(Suppl 1):3.∗ CORONIS Collaborative Group. Caesarean sectionsurgical techniques (CORONIS): a fractional, factorial,

    unmasked, randomised controlled trial.  Lancet  2013;382:

    234–48.

    Glavind J, Uldbjerg N. Caesarean section: in good surgical

    skills we trust.  Lancet  2013;382:188–9. Juszczak E, Farrell B. The CORONIS Trial: international

    study of caesarean section surgical techniques.   Trials  2011;112(Suppl 1):A103.

    National Perinatal Epidemiology Unit. Prevention of 

    maternal morbidity after caesarean section in developing 

    countries: a factorial RCT of surgical methods. http://

     www.npeu.ox.ac.uk/coronis/ accessed 2008.

    The CORONIS Trial Collaborative Group. The

    CORONIS trial. International study of caesarean sectionsurgical techniques: a randomised fractional, factorial trial.

    BMC Pregnancy and Childbirth 2007;7:24.

    Cromi 2008  {published data only}

    Cromi A, Di Naro E, Siesto G, Uccella S, Caringella A,

    Uboldi V, et al.Expansion of uterine incision at cesarean

    delivery: a randomized comparison of two techniques.

     American Journal of Obstetrics and Gynecology  2007;197(6Suppl 1):S36, Abstract no: 79.∗ Cromi A, Ghezzi F, Di Naro E, Siesto G, Loverro G,

    Bolis P. Blunt expansion of the low transverse uterine

    incision at cesarean delivery: a randomized comparison of 2

    techniques.  American Journal of Obstetrics and Gynecology 2008;199(3):292.e1–6.

    Dani 1998  {published data only}

    Dani C, Reali M, Oliveto R, Temporin G, Bertini G,

    Rubaltelli F. Short-term outcome of newborn infants born

    by a modified procedure of cesarean section: a prospective

    randomized study.   Acta Obstetricia et Gynecologica Scandinavica  1998;77:929–31.

    Darj 1999  {published data only}

    Darj E, Nordstrom ML. The misgav ladach method for

    cesarean section compared to the pfannenstiel method.  Acta Obstetricia et Gynecologica Scandinavica  1999;78(1):37–41.

    Ferrari 2001  {published data only}

    Ferrari A, Frigerio L, Candotti G, Buscaglia M, Petrone

    M, Taglioretti A, et al.Can Joel-Cohen incision and single

    layer reconstruction reduce cesarean section morbidity?.

    International Journal of Gynecology & Obstetrics  2001;72:135–43.

    Gutierrez 2008  {published data only}

    Gutierrez JG, Colo JA, Arreola MS. Comparative trial

    between traditional cesarean section and Misgav-Ladach

    technique [Comparación entre cesarea Misgav–Ladach y 

    cesarea tradicional].  Ginecologia y Obstetricia de Mexico

    2008;76(2):75–80.

    Hamar 2007  {published data only}∗ Hamar BD, Saber SB, Cackovic M, Magloire LK, Pettker

    CM, Abdel-Razeq SS, et al.Ultrasound evaluation of the

    uterine scar after cesarean delivery.  Obstetrics & Gynecology 2007;110:808–13.

    Hamar BR, Saber SB, Cackovic M, Magloire LK, Pettker

    CM, Abdel-Razeq SS, et al.Ultrasound evaluation of uterineincision healing after cesarean delivery - a randomized

    controlled study of one-versus two-layer closure.  American

     Journal of Obstetrics and Gynecology  2006;195(6 Suppl 1):S57.

    Hauth 1992  {published data only}

    Chapman SJ, Owen J, Hauth JC. One- versus two-later

    closure of a low transverse cesarean: the next pregnancy.

    Obstetrics & Gynecology  1997;89:16–8.∗ Hauth JC, Owen J, Davis RO. Transverse uterine incision

    closure: one vs two layers.  American Journal of Obstetrics and Gynecology  1992;167:1108–11.

    Hauth JC, Owen J, Davis RO, Lincoln T. Transverse uterine

    incision closure: one vs two layers.  American Journal of  

    Obstetrics and Gynecology  1991;164:407.Hauth JC, Owen J, Davis RO, Lincoln T, Piazza J.

    Transverse uterine incision closure: one vs two layers.

     American Journal of Obstetrics and Gynecology  1992;166:

    398.

    Hidar 2007  {published data only}

    Hidar S, Jerbi M, Hafsa A, Slama A, Bibi M, Khairi H. The

    effect of uterine incision expansion at caesarean delivery 

    on perioperative haemorrhage: a prospective randomised

    clinical trial. Revue Medicale de Liege  2007;62(4):235–8.

    Lal 1988  {published data only}

    Lal K, Tsomo P. Comparative study of single layer and

    conventional closure of uterine incision in cesarean section.

    International Journal of Gynecology & Obstetrics  1988;27:349–52.

    Magann 2002  {published data only}∗ Magann E, Chauhan S, Bufkin L, Field K, Roberts W,

    Martin JP Jr. Intra-operative haemorrhage by blunt verus

    sharp expansion of the uterine incision at caesarean delivery:

    a randomised clinical trial.  BJOG: an international journal 

    of obstetrics and gynaecology  2002;109:448–52.Magann E, Chauhan S, Bufkin L, Fields K, Roberts W,

    Martin JJ. Sharp versus blunt expansion of the uterine

    incision: influence on blood loss [abstract].   American

     Journal of Obstetrics and Gynecology  2001;184(1):S18.

    Moreira 2002  {published data only}

    Moreira P, Moreau JC, Faye ME, Ka S, Kane Gueye SM,Faye EO, et al.Comparison of two cesarean techniques:

    classic versus misgav ladach cesarean [Comparaison de

    deux techniques de cesarienne: cesarienne classique

    versus cesarienne Misgav Ladach].  Journal de Gynecologie,

    Obstetrique et Biologie de la Reproduction  2002;31(6):572–6.

    Poonam 2006  {published data only}

    Poonam, Banerjee B, Singh SN, Raina A. The Misgav 

    Ladach method: a step forward in the operative technique

    15Surgical techniques for uterine incision and uterine closure at the time of caesarean section (Review)

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    of caesarean section.  Kathmandu University Medical Journal 

    2006;4(2):198–202.

    Rodriguez 1994  {published data only}

    Rodriguez A, Porter KB, O’Brien WF. Digital vs

    instrumental expansion of the uterine incision at the time of 

    a low segment transverse cesarean section.  American Journal of Obstetrics and Gynecology  1994;170:339.∗ Rodriguez AI, Porter KB, O’Brien WF. Blunt versus

    sharp expansion of the uterine incision in low-segment

    transverse cesarean section.  American Journal of Obstetrics 

    and Gynecology  1994;171:1022–5.

    Sekhavat 2010  {published data only}

    Sekhavat L, Firouzabadi RD, Mojiri P. Effect of expansion

    technique of uterine incision on maternal blood loss in

    cesarean section.  Archives of Gynecology and Obstetrics  2010;

    282:475–9.

    Sood 2005  {published data only}

    Sood AK. Single versus double layer closure of low transverse

    uterine incision and caesarean section.  Journal of Obstetrics 

    and Gynaecology of India  2005;55(3):231–6.

    Studzinski 2002  {published data only}

    Studzinski Z. The Misgav-Ladach method for cesarean

    section compared to the Pfannenstiel technique [Ciecie

    cesarskie sposobem Misgav–Ladach w porownaniu z

    technika Pfannenstiela].  Ginekologia Polska  2002;73(8):672–6.

     Villeneuve 1990  {published data only}

    Villeneuve MG, Khalife S, Marcoux S, Blanchet P. Surgical

    staples in cesarean section: a randomized controlled trial.

     American Journal of Obstetrics and Gynecology  1990;163:

    1641–6.

     Von Rechenberg 1990  {published data only}Von Rechenberg KN. Use of a stapler for hysterotomy 

    in Cesarean section [Die Anwendung eines

    Klammernahtinstrumentes fur die Hysterotomie bei

    der Sectio Caesarea].  Zeitschrift fur Geburtshilfe und 

    Perinatologie  1990;194:85–9.

     Wallin 1999  {published data only}∗  Wallin G, Fall O. Modified Joel-Cohen technique

    for caesarean delivery.  British Journal of Obstetrics and Gynaecology  1999;106(3):221–6.

     Wallin G, Fall O. Modified Joel-Cohen technique for

    caesarean section. A prospective randomised study.   Acta 

    Obstetricia et Gynecologica Scandinavica Supplement  1997;76(167:2):24.

    Xavier 2005  {published data only}

     Ayres-de-Campos D, Patricio B. Modifications to the

    Misgav Ladach technique for cesarean section.   Acta 

    Obstetricia Gynecologica Scandinavica  2000;79:326–7.∗  Xavier P, Ayres-De-Campos D, Reynolds A, Guimaraes

    M, Costa-Santos C, Patricio B. The modified Misgav-

    Ladach versus the Pfannensteil-Kerr technique for cesarean

    section: a randomized trial.  Acta Obstetricia et Gynecologica 

    Scandinavica  2005;84(9):878–82.

     Yasmin 2011  {published data only}

     Yasmin S, Sadaf J, Fatima N. Impact of methods for uterine

    incision closure on repeat caesarean section scar of lower

    uterine segment.  Jcpsp, Journal of the College of Physicians & Surgeons - Pakistan 2011;21(9):522–6.

    References to studies excluded from this review  Ansaloni 2001  {published data only}

     Ansaloni L, Brundisini R, Morino G, Kiura A. Prospective,

    randomized, comparative study of misgav ladach versus

    traditional cesarean section at Nazareth Hospital, Kenya.

    World Journal of Surgery  2001;25(9):1164–72.

    Baxter 2008  {published data only}

    Baxter JK. Comparison of tissue retractors during cesarean

    delivery in obese women. http://clinicaltrials.gov/ct2/show/

    NCT00358592 (accessed 20 February 2008).

    Behrens 1997  {published data only}

    Behrens D, Zimmerman S, Stoz F, Holzgreve W.

    Conventional versus cohen-stark: a randomised comparison

    of the two techniques for cesarean section. 20th Congress of the Swiss Society of Gynecology and Obstetrics; 1997 June;

    Lugano, Switzerland. 1997:14.

    Buhimschi 2006  {published data only}

    Buhimschi CS, Buhimschi IA, Zhao G, Funai EF, Peltecu

    G, Saade GR, et al.Structural and biomedical properties of 

    the lower uterine segment above and below the reflection

    of the urinary bladder at cesarean section (CS).  American Journal of Obstetrics and Gynecology  2006;195(6 Suppl 1):

    S89.

    Dargent 1990  {published data only}

    Dargent D, Audra P, Noblot G. Utilisation of the Poly CS57

    clip for Caesarean section. A randomised trial. Journal de 

    Gynecologie, Obstetrique et Biologie de la Reproduction  1990;18:961–2.

    Decavalas 1997  {published data only}

    Decavalas G, Papadopoulos V, Tzingounis V. A prospective

    comparison of surgical procedures in cesarean section.  Acta Obstetricia et Gynecologica Scandinavica  1997;76(167):13.

    Doganay 2010  {published data only}

    Doganay M, Tonguc EA, Var T. Effects of method of 

    uterine repair on surgical outcome of cesarean delivery.

    International Journal of Gynecology & Obstetrics  2010;111(2):175–8.

    Falls 1958  {published data only}

    Falls F. Recent advances in obstetric and gynecologic

    surgery.  Journal of the American Medical Association 1958;

    166:1409–12.Gaucherand 2001  {published data only}

    Gaucherand P, Bessai K, Sergeant P, Rudigoz RC. Towards

    simplified cesarean section? [Vers une simplification de

    l’operation cesarienne?].  Journal de Gynecologie, Obstetrique et Biologie de la Reproduction 2001;30(4):348–52.

    Gedikbasi 2011  {published data only}

    Gedikbasi A, Akyol A, Ulker V, Yildirim D, Arslan O,

    Karaman E, et al.Cesarean techniques in cases with one

    16Surgical techniques for uterine incision and uterine closure at the time of caesarean section (Review)

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    previous cesarean delivery: comparison of modified Misgav-

    Ladach and Pfannenstiel - Kerr.  Archives of Gynecology and Obstetrics  2011;283(4):711–6.

    Ghezzi 2001  {published data only}

    Ghezzi F, Franchi M, Raio L, Naro Di E, Balestreri D,

    Miglierina M, et al.Pfannestiel or joel-cohen incision at

    cesarean delivery: a randomized clinical trial [abstract].

     American Journal of Obstetrics and Gynecology  2001;184(1):

    S166.

    Giacalone 2002  {published data only}

    Giacalone PL, Daures JP, Vignal J, Herisson C, Hedon

    B, Laffargue F. Pfannenstiel versus maylard incision for

    cesarean delivery: a randomized controlled trial.  Obstetrics & Gynecology  2002;99:745–50.

    Hameed 2004  {published data only}

    Hameed N, Ali MA. Maternal blood loss by expansion of 

    uterine incision at caesarean section--a comparison between

    sharp and blunt techniques.  Journal of Ayub Medical College  Abbottabad  2004;16(3):47–50.

    Heidenreich 1995  {published data only}Heidenreich W, Bruggenjurgen K. Modified Sarafoff suture

    for single layer closure of uterotomy in cesarean section. A 

    prospective study.  Zentralblatt fur Gynakologie  1995;117:

    40–4.

    Heimann 2000  {published data only}

    Heimann J, Hitschold T, Muller K, Berle P. Randomized

    trial of the modified misgav-ladach and the conventional

    pfannensteil techniques for cesarean section.  Geburtshilfe 

    und Frauenheilkunde  2000;60:242–50.

    Hohlagschwandtner  {published data only}

    Hohlagschwandtner M, Chalubinski K, Nather A,

    Husslein P, Joura EA. Sonographic findings after cesarean

    section without formation of a bladder flap [Sectio

    caesarea ohne Blasenpraparation: Eine sonographischeNachuntersuchung.].  Geburtshilfe und Frauenheilkunde 

    2002;62(2):163–6.∗ Hohlagschwandtner M, Ruecklinger E, Husslein P, Joura 

    E. Is the formation of a bladder flap at cesarean necessary?

     A randomized trial.  Obstetrics & Gynecology  2001;98:

    1089–92.

    Hoskins 1991  {published data only}

    Hoskins IA, Ordorica SA, Frieden FJ, Young BK.

    Performance of Cesarean section using absorbable staples.

    Surgery, Gynecology and Obstetrics  1991;172:108–12.

    Kiefer 2008  {published data only}

    Kiefer DG. A multicenter, randomized, controlled trial of 

    Seprafilm® adhesion barrier to reduce adhesion formation

    following cesarean delivery. http://clinicaltrials.gov/ct2/show/NCT00565643 (accessed 20 February 2008).

    Lodh 2002  {published data only}

    Lodh E, Bhattacharjee P. Single layer closure of caesarean

    section - a comparative study.  Journal of Obstetrics and Gynaecology of India  2002;52(2):35–6.

    Malvasi 2011  {published data only}

    Malvasi A, Tinelli A, Guido M, Cavallotti C, Dell’edera D,

    Zizza A, et al.Effect of avoiding bladder flap formation in

    caesarean section on repeat caesarean delivery.   European

     Journal of Obstetrics & Gynecology and Reproductive Biology 2011;159(2):300–4.

    Moroz 2008  {published data only}

    Moroz L, Bowers G, Hayes EJ, O’Brien J, Carroll T, Baxter

     JK. Self-retained compared with traditional retractors for

    cesarean delivery in obese women, a randomized controlled

    trial. Obstetrics & Gynecology  2008;111(4 Suppl):101S.

    Naki 2011  {published data only}

    Naki MM, Api O, Celik H, Kars B, Yasar E, Unal O.

    Comparative study of Misgav-Ladach and Pfannenstiel-

    Kerr cesarean techniques: a randomized controlled trial.

     Journal of Maternal-Fetal and Neonatal Medicine  2011;24

    (2):239–44.

    Ohel 1996  {published data only}

    Ohel G, Younis JS, Lang N, Levit A. Double-layer closure of 

    uterine incision with visceral and parietal peritoneal closure:

    are they obligatory steps of routine cesarean sections?.

     Journal of Maternal-Fetal Medicine  1996;5(6):366–9.

    Ozbay 2011  {published data only}Ozbay K. Exteriorized versus in-situ repair of the uterine

    incision at cesarean delivery: a randomized controlled trial.

    Clinical and Experimental Obstetrics and Gynecology  2011;

    38(2):155–8.

    Redlich 2001  {published data only}

    Redlich A, Koppe I. The ”gentle caesarean section“ - an

    alternative to the classical way of section. A prospective

    comparison between the classical technique and the method

    of misgav ladach [”Die sanfte Sectio“ – Eine Alternative

    zur klassischen Sectiotechnik – Prospektiver Vergleich der

    klassischen Technik mit der Misgav–Ladach–Methode].

     Zentralblatt fur Gynakologie  2001;123(11):638–43.

     Van Dongen 1989  {published data only}Van Dongen P, Nijhuis J, Jongsma H. Reduced blood

    loss during caesarean section due to a controlled stapling 

    technique.  Acta Obstetricia et Gynecologica Scandinavica 1997;76(167):20.

    Van Dongen PWJ, Nijhuis JG, Jongsma HW. Reduced

    blood loss during Caesarean section due to a controlled

    stapling technique.  European Journal of Obstetrics & Gynecology and Reproductive Biology  1989;32:95–102.

    References to studies awaiting assessment 

    Belci 2005  {published data only}

    Belci D, Kos M, Zoricic D, Kuharic L, Slivar A, Begic-

    Razem E, et al.Misgav Ladach surgical technique of cesarean

    section: our experience at Pula General Hospital [Carskirez po misgav ladachu: Iskustva u Puli].  Gynaecologia et Perinatologia  2005;14(4):171–8.

    Borowski 2007  {published data only}

    Borowski K, Andrews J, Hocking M, Hansen W, Fleener D,

    Syrop C. Ultrasonographic detection of cesarean scar defects

    in a trial of single versus double layer closure.   American Journal of Obstetrics and Gynecology  2007;197(6 Suppl 1):

    S62, Abstract no: 183.

    17Surgical techniques for uterine incision and uterine closure at the time of caesarean section (Review)

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    C H A R A C T E R I S T I C S O F S T U D I E S

    Characteristics of included studies   [ordered by study ID] 

    Batioglu 1998

    Methods Method of rand