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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15. Intrapartum Care: Care of healthy women and their babies during childbirth Clinical Guideline 190. Methods, evidence and recommendations December 2014, updated February 2017. National Institute of Health and Clinical Excellence.

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25. Less-Restrictive Food Intake During Labor in Low-Risk Singleton Pregnancies: A Systematic Review and Meta-analysis. Andrea Ciardulli, MD, Gabriele Saccone, MD, Hannah Anastasio, MD, and Vincenzo Berghella, MD. Article in Obstetrics and Gynecology · February 2017

26. Does adding milk to tea delay gastric emptying?  S. Hillyard S. Cowman R. Ramasundaram P. T. Seed G. O'Sullivan . BJA: British Journal of Anaesthesia, Volume 112, Issue 1, 1 January 2014, Pages 66–71.

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29. Anaesthesia. 1997 Dec;52(12):1224-9. A comparison of the effects of tramadol and morphine on gastric emptying in man. Murphy DB1, Sutton A, Prescott LF, Murphy MB.