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NATIONAL BOARD OF EXAMINATIONS
NEW DELHI
THESIS PROTOCOL SUBMISSION FORM
Name : Dr. Hajira Fathima S
Designation : Secondary DNB candidate in Obstetrics and Gynaecology
Institution : Southern Railway Headquarters Hospital, Perambur, Chennai.
Date of joining : 02/05/2017
Title of study : The effect of a policy of less restrictive food intake in labour on obstetric and neonatal outcomes in term uncomplicated singleton pregnancies - a randomized controlled trial
Guide : Dr. Shanta Bhaskaran
Additional Chief Health Director,
Obstetrics and Gynaecology,
Southern Railway Headquarters Hospital,
Perambur, Chennai.
Co Guide : Dr. C. Nishkala
Additional Chief Health Director,
Dept of Anaesthesia,
Southern Railway Headquarters Hospital,
Perambur, Chennai
Head Of Dept : Dr. Shanta Bhaskaran
Additional Chief Health Director,
Obstetrics and Gynaecology,
Southern Railway Headquarters Hospital,
Perambur, Chennai.
The Effect Of A Policy Of Less Restrictive Food Intake In Labour On
Obstetric And Neonatal Outcomes In Term Uncomplicated Singleton
Pregnancies- A Randomized Controlled Trial
1.1. INTRODUCTION
Labour, or the process of birthing, is undoubtedly a physiological marvel; albeit with its fair
share of unpredictable alarming occurrences. Obstetricians, in their quest to prevent such
unpleasant outcomes, have ‘medicalized’ this physiological process. From the posture in which
she should deliver, to when she can ambulate, and what she can or cannot eat while in labour –
the laboring woman has been deprived of autonomy in such matters by the midwife /
obstetrician. Such limitations create a feeling of fear and intimidation toward the process of
labour in the parturient’s mind. In this study, we give laboring mothers the freedom to ‘eat at
will’, after ruling out causes that might increase their risk for aspiration.
Historically, food intake has been restricted in labour to protect women from pulmonary
aspiration should general anaesthesia be needed for an emergency operative delivery. It was in
1946 that Curtis Mendelson published his landmark study[1] addressing the morbidity and
mortality associated with aspiration. He recommended that oral intake in labour be either
restricted or denied. This suggestion proved influential, and restriction of oral intake in labor
became the norm.
Modern obstetrics, especially in the setting of advances in obstetric anesthesia, does not mirror
the clinical landscape of Mendelson. It is well known that current practices in obstetric
anesthesia have successfully reduced rates of general anesthesia and its attendant
complications.Also, the risk of aspiration in normal ‘low risk’ labor is probably exaggerated.
This is why, although the physiology of pregnancy increases a woman's risk for aspiration by
delaying gastric emptying, pulmonary aspiration itself is rare. A study by Sleutel and Golden in
1999 estimated the risk of maternal mortality due to aspiration to be only around 7 in 10 million
births[2]. Hence it is questionable if Mendelson’s findings should inform current
recommendations, especially since no increase in maternal mortality is reported with the practice
of allowing food and drink in labor (Ludka and Roberts, 1993)3. Even the triennial reports of the
United Kingdom Confidential Enquiries into Maternal and Child Health indicate, that in spite of
an increasingly flexible attitude in the UK toward oral intake during labor, the incidence of
aspiration has actually declined in the past twenty years[4].
It is well known that labour is a highly demanding metabolic challenge for the mother and her
fetus. Christopher Harty et al [5] suggested that the energy and caloric demands of laboring
women are similar to those of marathon runners. Metzger et al [6] showed that women in the third
trimester of pregnancy exhibit a state of “accelerated starvation”, if denied food and drink.
Maternal ketonura is thought to cause impaired myometrial function and dysfunctional labour [7].
Hunger also increases the psychological stress of labor and the American College of Nurse-
Midwives (ACNM) state in their 2008 clinical guideline [8] on providing oral nutrition to women
in labor that in addition to providing hydration, nutrition, and comfort, self-regulating intake
“decreases a woman’s stress level and provides her with a feeling of control.”
Consequently, in some countries, the policy of routine fasting for all parturients has been
challenged. Wide differences exist in the management of caloric intake during labor, varying
dramatically by institution and country [9]. Approaches range from "ice chips only", as is the
policy in many hospitals in the U.S., to a liberal diet for women at low risk of needing
anesthesia. In the Netherlands, 79% of clinicians allow food intake in labour [10], and among 351
birth units in the United Kingdom 32% allow food and drink [11]. Although it has not been
formally evaluated, many clinicians have observed that women request food in labour. In 2000,
Armstrong surveyed women within 36 hours after delivery and 30% of women wished they had
been able to eat during labor [12].
Therefore, it is time to reevaluate the necessity of oral intake restriction during labor and to
assess the outcomes of allowing food and drink in labour.
1.2. REVIEW OF LITERATURE
As early as 1986, Penny Simkin [13] presented a paper on the topic of stress in labor. She explored
the often overlooked outcomes of patient satisfaction and autonomy and reported that 57% of
women find restriction of food intake to be moderately or very stressful.
A study of 106 women by O Reilly et al (1993)14 indicated that when given a choice, all study
participants chose a variety of types and amounts of oral intake throughout all stages of labor.
Over 80% of women who ate or drank during labor had no emesis, suggesting that women who
choose to eat in labor are at relatively low risk for complications related to such intake.
HC Scheepers (2001, Netherlands) [9] conducted a study with 211 nulliparous women and noted
that the incidence of an instrumental delivery due to a non-progressing second stage was lower in
women with caloric intake (13% vs 24%, p = 0.04).
Notably, however, recommendations from professional organizations on the oral intake during
labor remain quite varied (Table 1). The National Institute for Health and Clinical Excellence in
a 2007 consensus opinion, updated and upheld in Feb 2017, acknowledges that there is lack of
evidence to restrict women's access to fluids and food during labour. Their guideline states that
women may eat a light diet in established labour unless they have received opioids or develop
risk factors that make a general anaesthetic more likely [15].
In 2013, the American Congress of Obstetricians and Gynaecologists (ACOG) and American
Society of Anesthesiologist (ASA) reaffirmed a joint practice guideline stating, “The oral intake
of modest amounts of clear liquids may be allowed for uncomplicated laboring patients” but that
“solid foods should be avoided in laboring patients.” They go on to state that “patients with risk
factors for aspiration (e.g. morbid obesity, diabetes, and difficult airway, or patients at increased
risk for operative delivery) may require further restrictions of oral intake, determined on a case-
by-case basis” [16]. In contrast to the joint ACOG/ASA recommendations, the World Health
Organization (WHO) recommends that because the energy demands of labor are so great and
because replenishment ensures maternal and fetal well-being, healthcare providers should not
interfere with a woman’s desire for oral intake during labor [17]. Although, European guidelines
continue to discourage women from intake of solid food during labor, they acknowledge the low
incidence of aspiration in obstetrics and therefore state that "low risk women could consume low
residue foods (biscuits, toasts, cereals) during labor” [18].
The Society of Obstetricians and Gynecologists of Canada (SOGC) suggests that women in
active labour could be recommended light or liquid diet, depending on their preferences (Society
of Obstetricians and Gynecologists of Canada 1998).
Table 1: Recommendations of Professional Organizations on Restriction of Oral
Intake during Labor
In a 2013 Cochrane review combing evidence from 5 randomized, controlled trials involving
3130 women in active labor, Singata and colleagues sought to determine the benefits and harms
of oral fluid or food restriction in labor[19]. All studies included women in active labor who were
deemed to be at low risk of needing a general anesthetic. One study looked at complete
restriction vs giving women the freedom to eat and drink at will [20]. Two studies looked at
allowing water only compared with giving women specific fluids and foods.[21,22] An additional 2
studies looked at giving water only vs giving women carbohydrate drinks.[23,24]
Primary outcomes included cesarean delivery, operative vaginal birth, and a 5-minute Apgar
score of < 7. Secondary outcomes were duration of labor and maternal nausea or emesis.No
statistically significant differences were identified in any primary or secondary outcome.The
authors note that most women seem to naturally limit their intake as labor gets stronger. They
concluded that low risk women should have the right to choose whether or not they would like to
eat or drink during labor.
Critical to interpretation of these studies and application of the findings to practice is
consideration of what it means to be "low risk." Exclusion criteria for these studies varied but
commonly included preterm labor, multiple gestation, breech position, intent to use analgesia
during labor, and "any medical or obstetrical condition increasing risk for instrumental delivery
or cesarean. “These results may be less generalizable to hospitals with a high rate of cesarean
delivery or epidural anesthesia”.
Recently, Ciardulli et al (February, 2017)[25] conducted a systematic review and meta analysis of
ten randomized trials comparing a policy of less-restrictive food intake with a policy of more
restrictive food intake during labor. Ten trials, including 3,982 laboring women, were included.
All the studies involved laboring singletons considered at low risk because they had no obstetric
or medical complications that would increase the likelihood of cesarean delivery. In three
studies, women were allowed to select from a low-residue diet throughout the course of labor.
One study had honey date syrup as the allowed food intake. Five studies had carbohydrate drinks
as food intake in labor. The last one was the only trial that allowed unrestrictive food intake. In
the included studies, all women in the intervention group were allowed the assigned food intake
until delivery, whereas women in a control group were allowed only ice chips, water, or sips of
water until delivery. The primary outcome was the mean duration of labor. They concluded that
a policy of less-restrictive food intake was associated with a significantly shorter duration of
labor (mean difference –16 minutes, 95% CI 225 to 27). There were no significant differences in
obstetric or neonatal outcome nor was there an increase in the incidence of vomiting.
Regurgitation during general anesthesia and Mendelson syndrome did not occur in either group.
1.3. AIMS AND OBJECTIVES
To compare the effect of restricted versus non restricted oral intake during labour on obstetric
and neonatal outcomes.
1.4. MATERIALS AND METHODS
Design: Prospective single blinded randomised controlled trial
Period of study: June 2017-May 2018
Setting: Dept.of Obstetrics and Gynaecology,
Southern Railway Headquarters Hospital
Ayanavaram, Chennai
Participants: All term nulliparae, with no medical or obstetric complications, in labor
with an average sized singleton cephalic presenting fetus and with a cervical dilatation of
<4 cm. Eligible women will be informed of the 2 arms of the study during the third
trimester of pregnancy. Safety of both types of intake will be convincingly explained to
them and they shall be told that random assignment to either of the study arms shall be
done at the time of admission
1.4.1. INCLUSION CRITERIA:
Age >18 years, < 35 years
Nulliparous or multiparous
> 36 weeks’ gestation,
with an average sized (estimated fetal weight of 2.5 to 3.5 Kg ) singleton cephalic
presenting fetus, and
In labour with a cervical dilatation of less than 4 cm.
Induction or augmentation of labour included.
1.4.2. EXCLUSION CRITERIA:
History of any obstetric or fetal complication with increased likelihood of operative
delivery(such as eclampsia, pre-eclampsia, gestational diabetes, placenta previa, placental
abruption, multiple pregnancy, chorioamnionitis , meconium-stained amniotic fluid, oligo
or polyhydramnios, IUGR, trial of labor for suspected CPD, precious baby)
Women with a known medical complication that can increase the chances of an operative
delivery. (Eg. Obesity, diabetes,etc)
Women in severe pain, intending to use parenteral opioids (i.m. pethidine) for analgesia
during labour. Tramadol for analgesia is allowed.
Women who are unable to comprehend elements of the study.
1.4.3. RANDOMISATION
After women give informed, written consent, the attending resident shall assign them either into
the“eating” or the “current hospital policy” group by random selection of sealed pre randomised
envelopes.
1.4.4. METHOD OF STUDY
DIETARY ADVICE
After randomisation, women in the eating group shall be allowed to select at will from a low-
residue diet throughout the course of labour (Table 3). The emphasis shall be on small regular
amounts of food rather than eating set regular meals. All women shall have free access to water
and ice chips.The decision to eat or drink in labor shall be the woman’s. If she intuitively wishes
to restrict intake as labour gets stronger,she may do so. We believe that, with appropriate
counselling, women are competent to make an informed decision surrounding their desire to eat/
drink during labor.
TABLE 3
Breakfast 2 idlis with chutney / cornflakes with milk/ 2 slices of white bread and
jam
Snack Semi sweet biscuits (2)/ (3-4) ripe dates/ 2 bananas
Lunch 1 cup of rasam sadam (a local dish prepared with rice and light tomato
soup) or rice with moong dhal (green gram) with 2 tablespoons of boiled,
skinned vegetable(fresh beans, cabbage, brinjal). Avoid fried vegetables.
Snack Fresh juice or clear vegetable soup 150 ml or a banana
Dinner 2 idlis with chutney (or) 200 ml of rice porridge (or) 2 slices of white
bread with sugar or milk
Snack Semi sweet biscuits (2) / (3-4) ripe dates or a banana
Fluids allowed
throughout labour
Water/ice chips/ coffee/ tea/ fruit juice/ milk (+ sugar)
Women in the “current hospital policy” group shall be advised oral intake as per the hospital
policy in place, that is, clear fluids such as juices and soups, and milk. Ingestion of milk in
modest amounts (~ 50 ml) has been shown to have no difference on gastric emptying timesx.and
therefore has the same fasting restrictions as are applicable on ingestion of clear fluids [26].
Women in this group, who express a desire to eat, shall be allowed to do so; with case report
forms reflecting such change.
Women in either group shall be made aware that both forms of oral intake comprise standard
level of care at various other institutions.
Adequacy of hydration will be assessed by checking for ketonuria on a 4 hourly basis. Routine
IV fluids for hydration shall not be used in either group. Although safe, intravenous fluids
restrict movement and may not be required (ACOG Committee Opinion 2017)28. However, in
women who show features of dehydration, manifesting as either ketonuria or CTG abnormalities,
intravenous hydration will be begun. The type of solution and rate of infusion shall be decided
based on the individual case.
OBSTETRIC MANAGEMENT
The Resident doctors attending to the woman’s obstetric management can obviously not be
blinded to trial allocation. The consultants deciding on obstetric interventions like operative
vaginal delivery or cesarean section will be blinded to the trial intervention allocation. Vaginal
dilatation will be assessed at four hourly intervals. Continuous external fetal heart rate
monitoring and tocodynamometry will be used as indicated. Continued observation and
monitoring during labor is required to evaluate for potential need for restriction of oral
intake should the clinical circumstances change. Oxytocin infusion, when indicated, will be
administered according to the hospital protocol. No routine antacid will be administered.
We recognise that continued collaboration of anesthesiologists, obstetricians, midwives, and
pediatricians is paramount to optimizing perinatal outcomes.
ANALGESIA DURING LABOUR
The women can choose 50:50 nitrous oxide and oxygen (Entonox) or epidural analgesia. A low
dose local anaesthetic and opioid solution (bupivacaine 0.1% with fentanyl 2 μg/ml) will be used
for epidural analgesia, not exceeding a maximum dose of 30 ml/hour. A functioning epidural
catheter for analgesia may actually be protective for aspiration as it may prevent the need for
general anesthesia in the setting of an emergent cesarean delivery, thus altering the woman’s risk
profile. Also, intramuscular tramadol for analgesia is not contraindicated in either of the
groups[29]
DATA COLLECTION
The attending resident shall enter outcome data on to a data sheet. Age, ethnicity, food intake for
six hours before labour and during labour are to be recorded in addition. Food intake in the six
hours before labour is classified as no intake, snacks, a light meal, or a large meal. Food intake
during labour shall be categorized as no intake, water only, liquids, solid food . The trial
coordinator shall be responsible for training residents on the study protocol and ensuring
adherence to the protocol and for the daily collection of data sheets. All data will then be entered
on to a Microsoft Excel 2000 spreadsheet.
PRIMARY OUTCOMES
Rate of spontaneous vaginal delivery
Duration of labour (defined as time from onset of the active phase of first stage until the
end of the second stage till the baby is delivered)
SECONDARY OUTCOMES
Need for intravenous oxytocin for the augmentation of labour.
Incidence of dystocia.
Instrumental and caesarean delivery rates
Incidence of vomiting
Adequacy of maternal pushing efforts as assessed by the resident conducting her
delivery.
Maternal satisfaction (to be assessed by a postpartum questionnaire 24 hours after
delivery).
Neonatal APGAR < 7 at 5 minutes
NICU admission
Fully breastfeeding at discharge
Pulmonary aspiration/ Mendelson’s syndrome
1.4.5. SAMPLE SIZE ESTIMATION:
Average number of deliveries per year is approximately 1100 in Southern Railway HQ Hospital.
Among them approximately 300 are elective caesareans.800 are allowed to labour.
SAMPLE SIZE:
Comparison of two proportions
(Sample size of each group)
1.4.6. STATISTICAL ANALYSIS:
1.5. REFERENCES
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