BMI IN FIRST TRIMESTER AND ITS ASSOCIATION WITH SUCCESSIVE WEIGHT GAIN DURING PREGNANCY,

OBSTETRIC COMPLICATIONS , MATERNAL AND FETAL OUTCOMES.

BY

MAJ HARPREET KAUR

SYNOPSIS FOR REGISTRATION OF SUBJECT FOR DISSERTATION

TO

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA

IN PARTIAL FULFILLMENT OF REGULATIONS FOR THE AWARD OF

MASTER OF SURGERY IN OBSTETRICS AND GYNAECOLOGY

DEPARTMENT OF OBSTETRICS AND GYNAECOLOGYCOMMAND HOSPITAL AIR FORCE, BANGALORE.

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA

ANNEXURE II

1. Name of the Candidate and address (in block letters)

MAJ HARPREET KAURCOMMAND HOSPITAL AIR FORCE,BANGALORE – 560 007.

2. Name of the institution COMMAND HOSPITAL AIR FORCE, BANGALORE – 560 007.

3.Course of study and subject

MS (OBS & GYNAE)

4.Date of admission to the course

JULY 2013

5. Title of the topic BMI IN FIRST TRIMESTER AND ITS ASSOCIATION WITH SUCCESSIVE WEIGHT GAIN DURING PREGNANCY, OBSTETRIC COMPLICATIONS, MATERNAL AND FETAL OUTCOMES.

6. Brief resume of the intended work:

6.1 Need for the study

6.2 Objectives of the study

IA

IB

7. Material and methods

7.1 Source of data

7.2 Methods of collection of data (including sampling procedure if any)

7.3 Methods of determination

7.4 Method of analysis

7.5 Does the study require any investigation to be conducted on patient or other humans or animals? If so, please describe briefly.

7.6 Has ethical clearance been obtained from your institution?

IIA

IIB

IIC

IID

IIE

YES

8 List of referencesIII

9. Signature of Candidate

10. Remarks of Guide

11. Name and Designation of (in block letters)

11.1 Guide

11.2 Signature

11.3 Co-Guide (if any)

11.4 Signature

11.5 Head of Dept

11.6 Signature

DR RITOO BHALLA PROFESSORDEPT OF OBSTETRICS & GYNAECOLOGY COMMAND HOSPITAL AIR FORCE, BANGALORE.

-

COL MANASH BISWAS.PROFESSOR AND HEAD DEPT OF OBSTETRICS & GYNAECOLOGY, COMMAND HOSPITAL AIR FORCE, BANGALORE.

12.1 Remarks of the chairman and principal

12.2 Signature

AIR VICE MARSHALCOMMANDANTCOMMAND HOSPITAL AIR FORCE, BANGALORE

ANNEXURE - 1

A 6.1 NEED FOR STUDY

The prevalence of obesity has increased over past 10 years.In 2009 the Institute of Medicine (IOM) published revised pregnancy weight gain guidelines that are based on pre-pregnancy body mass index (BMI) ranges recommended by the WHO. These ranges are independent of age, parity, smoking history, race, and ethnic background. The revised IOM recommendations define normal weight as a BMI of 18.5-24.9, overweight as a BMI of 25-29.9, and obesity as a BMI of 30 or greater. The IOM guidelines do not differentiate between class 1 obesity BMI 30-34.9, class 2 obesity BMI- 35-39.9, and class 3 obesity BMI >40.

PREGNANCY COMPLICATIONS

Overweight and obese women are at increased risk of several pregnancy complications, including gestational diabetes mellitus, hypertension, preeclampsia, cesarean delivery and post partum weight retension. Similarly fetuses of pregnant women who are overweight or obese are at increased risk of prematurity, stillbirth, congenital anomalies, macrosomia with possible birth injury, and childhood obesity. Additional concerns include potential intrapartum, operative, and post operative complications and difficulties related to anaesthesia management. Obese women are also less likely to initiate and sustain breast feeding.

MATERNAL COMPLICATIONS

A BMI of 30-39.9 is associated with an increased risk of 1. Gestational diabetes mellitus2. Gestational hypertension3. Preeclmpsia4. Fetal macrosomia

When compared with a BMI of less than 30.Cesarean delivery rate is also higher for women with BMI of 30-34.9.Atleast three cohort studies suggest that obesity is an idependant risk factor for spontaneous abortion among women who undergo infertility treatment.

FETAL COMPLICATIONS

Associated fetal risks are 1. Prematurity2. Still birth3. Congenital abnormalities4. Macrosomia5. Childhood and adolescent obesity

A large Swedish cohort study reported a greater risk of antepartum stillbirth among obese patients than among who had normal BMI.Obese pregnant women are more likely to give birth to an infant with congenital anomalies and obesity also lowers detection rates of fetal anomalies during prenatal ultrasonography. Data establish that the risk of neural tube defects among obese pregnant women is double that of pregnant women with normal weight after correcting for diabetes as a potential confounding factor.

INTRAPARTUM COMPLICATIONSChallenges associated with anaesthesia management and the increased risk of complicated and emergent cesarean delivery are discussed below. Other potential problems include difficulty in estimating fetal weight even with ultrasonography and the inability to obtain interpretable external fetal heart rate and uterine contraction patterns.Anaesthesia managementthe use of epidural or spinal anesthesia is recommended in the obese pregnant patient when anaesthesia is needed. However it may be technically difficult to administer this type of anaesthesia because of obscured landmarks, difficult positioning and excessive layers of adipose tissue. Alternatively, the use of general anaesthesia in obese pregnant women also poses several challenges, including difficult endotracheal intubation due to excessive tissue and edema and intraoperative respiratory events from failed or difficult intubation.

Cesarean deliveryOperative and postoperative complications among obese pregnant women include increased risk of excessive blood loss, operative time greater than 2 hours, wound infection and endometritis. Sleep apnea occurring in this group may further complicate anaesthetic management and post operative care.Obese women who require cesarean delivery have an increased incidence of wound breakdown. For obese women who require cesarean delivery, consideration is given to use of higher dose of preoperative antibiotics for surgical prophylaxsis.There is increased risk of venous thromboembolism, placement of pneumatic compression devices before cesarean delivery is recommended for all women not

receiving thromboprophylaxis. Individual risk assessment will lead some health care providers to plan thromboprophylaxis with pneumatic compression devices and unfractioned heparin or low molecular weight heparin in such patients.Because of increased likelihood of complicated and emergent cesarean delivery, extremely obese women may require specific resources, such as additional blood products, a large operating table and extra personnel in delivery room. Particular attention to the type and placement of the surgical incision is needed, i.e placing the incision above the panniculus adiposus.

B 6.2 OBJECTIVE OF THE STUDY

1. To study maternal and fetal complications, outcome of pregnancy and surgical complications in patients followed up, who are detected to be overweight during first trimester.

ANNEXURE-II.

7. MATERIALS AND METHOD

A 7.1 SOURCE OF DATA:

Pregnant ladies registered and followed up at antenatal clinic in Command Hospital Air Force Bangalore.

B 7.2 METHOD OF COLLECTION OF DATA

1. Patient details will be recorded as per proforma attached

2. Inclusion criteria:

1. All antenatal cases booked at Command Hospital Bangalore in first trimester with BMI more than 25.

3. Exclusion criteria: 1. Patients who cannot be followed up2. Patients booked in second or third trimester3. Patients with BMI less than 25 at the time of booking

Each case will be documented as per the under mentioned proforma. An informed consent will be obtained from each of the patients for being a part of the study.

PROFORMA

DEPARTMENT OF OBSTETRICS AND GYNAECOLOGYCOMMAND HOSPITAL AIR FORCE BANGALORE

PATIENT PARTICULARS

PT NAME:____________________________________

AGE :_________

DEPENDENT OF :_________________________

RELATIONSHIP:WIFE/DAUGHTER/SELF

SER. NO:_____________________________ RANK:_______________________________

UNIT :___________ADDRESS AND PHONE :____________________________________

_____________________________________

______________________________________________________________________________ DATE OF BOOKING/FIRST VISIT AT COMMAND HOSPITAL AIR FORCE BANGALORE AND REGISTRATION NUMBER-

LAST MENSTRUAL PERIOD-

EXPECTED DATE OF DELIVERY-

GRAVIDA- PARITY- LIVING - OBSTETRIC HISTORY-

PAST HISTORY-

MEDICAL-

SURGICAL-

GYNECOLOGICAL-

FAMILY HISTORY-

BODY MASS INDEX AND WEIGHT –

FIRST TRIMESTER-

SECOND TRIMESTER-

THIRD TRIMESTER-

OTHER RELEVANT EXAMINATION FINDINGS-

COMPLICATIONS IN FIRST TRIMESTER-

COMPLICATIONS IN SECOND TRIMESTER-

COMPLICATIONS IN THIRD TRIMESTER-

PREGNANCY OUTCOME-

MODE OF DELIVERY-

VAGINAL-

LOWER SEGMENT CESAREAN SECTION INDICATION AND ANY ANAESTHESIA COMPLICATIONS-

FETAL COMPLICATIONS IF ANY

POST PARTUM/OPERATIVE COMPLICATIONS-

OTHER RELEVANT INVESTIGATIONS- _____________________________________________________________________________________________________________________________________________________________________________________________________

C 7.3 METHODS OF DETERMINATION: All the patients booked in first trimester and with BMI more than 25 will be followed up during routine antenatal visits and serial weight gain and BMI will be recorded in the patient proforma. Patients will be closely monitored for development of any obstetric complications and managed accordingly.

D 7.4 METHOD OF ANALYSIS :This prospective observational study will be carried out for a period of two years

in the Dept of Obstetrics and Gynaecology of Command Hospital Air Force

Bangalore. Pregnant ladies attending antenatal clinic at this hospital will be

screened for excessive weight gain and any associated complications. The study

group would comprise of a minimum of 100 pregnant ladies with BMI more than

25 at the time of booking.

E 7.5 DOES THE STUDY REQUIRE ANY INVESTIGATION TO BE CONDUCTED ON PATIENT OR OTHER HUMANS OR ANIMALS?

NO

ANNEXURE III

8. LIST OF REFERENCES:

List of References1. Flegal KM, Carroll MD, Ogden CL. Prevalence of obesity and trends in the

distribution of body mass index among US adults, 1999-2010. JAMA 2012;

307:491-7.

2. Institute of Medicine. Weight gain during pregnancy: reexamining the guidelines.

Washington , DC: National Academies Press; 2009

3. Weight gain during pregnancy .committee Opinion No.548. American college of

Obstetricians and Gynecologists. Obstet Gynecol 2013;121:210-2.

4. Cedergren MI. maternal morbid obesity and the risk of adverse pregnancy

outcome. Obstet Gynecol 2004;103:219-24.

5. Sebire NJ, Jolly M, Harris JP, Wadsworth J,et al. maternal obesity and

pregnancy outcome: a study of 287,213 pregnancies in London. Int J Obes

Relat Metab Disord 2001;25:1175-82.

6. Oken E, Taveras EM, Kleinman KP, Rich- Edwards JW, Gillman MW.

Gestational weight gain and child adiposity at age 3 years. Am J Obstet Gynecol

2007;196:322.el-8.

7. Li R, Jewell S, Grummer –Strawn L. Maternal obesity and breast feeding

practices. Am J Clin Nutr 2003;77:932-6.

8. Bellver J, Rossal LP, Bosch E, Zuniga A, Corona JT, Melendez F, et al. obesity

and the risk of spontaneous abortion after oocyte donation.fertil Steril

2003;79:1136-40

9. Fedorcsak P, Storeng R, Dale PO, Tanbo T, Abyholm T. Obesity is a risk factor

for early pregnancy loss after IVF or ICSI. Acta Obstet Gynecol

Scand2000;79:43-8.

10.Lashen H, Fewar K , Sturdee DW. Obesity is associated with increased risk of

first trimester and recurrent miscarriage: matched case control study. Hum

Repord 2004;19:1644-6.

CERTIFICATE FROM ETHICAL COMMITTEE

1. The Committee has examined the scope including the need, objectives, method of data collection and human interventions of the following study to be carried out by Maj Harpreet Kaur, MS student (Department of Obstetrics and Gynaecology) under the guidance of Dr Ritoo Bhalla and the title of which is:

2. BMI IN FIRST TRIMESTER AND ITS ASSOCIATION WITH SUCCESSIVE WEIGHT GAIN DURING PREGNANCY, OBSTETRIC COMPLICATIONS, MATERNAL AND FETAL OUTCOMES.

3. The committee has no objection for undertaking this study at Command Hospital Air Force, Bangalore.

Air Cmde MK BediAOC MTCChairman Ethical Committee

Dept of Medicine

Col SK Jha Wg Cdr S Kaistha OIC PG Cell Rep of AFWWA Sqn Ldr Salini Chaudhary Mrs Vasantha Kishore OIC Legal Cell Counsellar e-support Dr V Sinha Scientist D Physiologist

Col SC DashProfessor & HODSurgery

Brig MS PrakashProfessor & HODMedicine

Gp Capt H Sahni OIC AFMRCMember secretary

CERTIFICATE OF ACCEPTANCE BY THE GUIDE

I , Dr Ritoo Bhalla, Professor, Department of Obstetrics and Gynaecology ,

Command Hospital Air Force Bangalore, hereby certify that I accept Maj Harpreet Kaur as a candidate for MS Obstetrics and Gynaecology course. The title of her dissertation is as follows –

BMI IN FIRST TRIMESTER AND ITS ASSOCIATION WITH SUCCESSIVE WEIGHT GAIN DURING PREGNANCY, OBSTETRIC COMPLICATIONS, MATERNAL AND FETAL OUTCOMES.

.

She will be under my guidance during the entire period of her study and thesis work.

Date : Dr Ritoo Bhalla Professor Place: Obstetrics & Gynaecology

CERTIFICATE FROM THE HEAD OF THE INSTITUTION

Permission is hereby accorded to the student Maj Harpreet Kaur, to undergo

MS, Obstetrics and Gynaecology course being conducted at Command Hospital

Air Force, Bangalore affiliated to Rajiv Gandhi University of Health Sciences

Karnataka, Bangalore commencing from July 2013 under the guidance of Dr

Ritoo Bhalla, Professor, Dept of Obstetrics & Gynaecology, Command Hospital

Air force, Bangalore- 560007

COMMANDANT AND PRINCIPAL,COMMAND HOSPITAL AIR FORCE, BANGALORE- 560007.

CONSENT FORM

I________________________________W/O, D/O_________________________hereby give my consent to be part of dissertation study of Maj Harpreet Kaur. Topic – BMI in first trimester and its association with successive weight gain during pregnancy, obstetric complications, maternal and fetal outcomes.

Weight will be checked during routine antenatal visits.

There will be no direct benefit to me as a participant. However the information provided would help the health professional to better understand the correlation between excessive weight gain during pregnancy and adverse obstetric outcomes.

By signing this form I acknowledge that I have read or had this form read and explained to me in the language I understand and fully understand its contents.

SIGNATURE___________________

SIGNATURE OF WITNESS_________________________

STUDY INFORMATION SHEET FOR THE PATIENT

TITLE- BMI IN FIRST TRIMESTER AND ITS ASSOCIATION WITH SUCCESSIVE WEIGHT GAIN DURING PREGNANCY,OBSTETRIC COMPLICATIONS, MATERNAL AND FETAL OUTCOMES.

INVESTIGATOR- MAJ HARPREET KAUR.

Dear Madam,

We are doing this study to find out the association between excessive weight gain in pregnancy and its affect on pregnancy outcome.For this study we will be checking your weight atleast once in each trimester.

We seek your consent to participate in this study.

BENEFITS OF STUDY TO THE PATIENT-

You are likely to be benefitted by early detection of excessive weight gain and any subsequent complications . It will allow us to take timely and appropriate corrective measures which may prevent pregnancy loss.

POTENTIAL RISKS AND DISCOMFORT-

None.

ALTERNATIVE TO PARTICIPATION-

The patient is free not to participate in the study.

CONFIDENTIALITY-

All information that you provide during the study will be kept confidential.

CONTACTS-

If you have any further questions , any time during the course of study, you can contact

Maj Harpreet KaurResident Department of Obstetrics and GynaecologyCommand Hospital Air Force, Bangalore