Antenatal Care Bundle for Preventing Stillbirths: Proposed Intervention by Stillbirth Society of India

Abstract

Antenatal Care Bundle” presents evidence-based antenatal care interventions aimed at reducing stillbirths, developed by the Stillbirth Society of India. The interventions are designed to complement WHO recommendations, focusing on risk assessment, maternal and fetal monitoring, and management of fetal growth restriction, particularly in low-resource settings. They are intended to be adopted by all the practitioners to provide standard care to every pregnant woman for optimal outcomes. Each section of this bundle has undergone extensive discussion followed by consensus. The recommendations have been graded according to the level of evidence-based as recommended by NICE guidelines.

BACKGROUND

Stillbirth is a silent epidemic with a devastating impact on parents, families, society, and healthcare providers (HCPs). A baby is stillborn every 16 seconds and 84% of global stillbirths occur in low- and middle-income countries.[1] A stillbirth is just the tip of the iceberg, a much and represents a much larger problem related to healthcare accessibility, quality, and lack of awareness of danger signals amongst the community and HCPs The UNICEF launched the Every Newborn Action Plan (ENAP) in 2014 setting a global target of fewer than 12 newborn deaths per 1000 live births and fewer than 12 stillbirths per 1000 total births by 2030.[2] India launched its more ambitious newborn action plan (India Newborn Action Plan; INAP) in September 2014 setting a target of reducing NMR and Stillbirth rates to a single digit by 2030 by improving access to quality antenatal and intra-natal care to mothers.[3] To achieve this we need to target preventable stillbirths.

OBJECTIVE AND METHODOLOGY

A ‘care bundle’ is a collection of evidence-based interventions that when applied together in managing a particular condition improves the processes of care and outcomes The team of experts of the Stillbirth Society of India has reviewed and compiled the latest available evidence on antenatal care interventions in reducing stillbirth. The objective was to formulate context-specific interventions that can be adapted and integrated with existing WHO recommendations on antenatal care. These interventions are designed to improve pregnancy outcomes and reduce stillbirths in India, particularly in low-resource settings. This document includes good clinical practice recommendations on risk assessment and intervention at booking visit/preconception visits, maternal monitoring in 2^nd and 3^rd trimesters, fetal monitoring in 2^nd and 3^rd trimesters, management of decreased fetal movements, and management of low-risk mothers diagnosed with fetal growth restriction. The recommendations have been graded according to the level of evidence-based recommended by NICE guidelines.[4]

I. RISK ASSESSMENT AND INTERVENTIONS AT BOOKING VISIT

I.1 Risk assessment at booking visit.

• Detailed history and examination are desirable at booking visits to flag mothers at high risk for stillbirth. Risk factors for stillbirth with an estimated stillbirth rate per 1000 total births are summarized in Table 1.

• Triaging pregnancies into high-risk or low-risk for stillbirth based on the presence or absence of risk factors must be initiated at the first visit and continued at each subsequent visit. This helps in deciding the road map for further course of care. High-risk cases need intensive multidisciplinary care, timely identification, and surveillance.

Table 1.

Risk factors for Stillbirth Estimated risk of Stillbirth per 1000 Total births[4,5,6,7]

a. Social Demographic factors for stillbirths     Maternal age ≥35 years     Maternal age <20 years     Non-Hispanic black race     Obesity BMI >30 Kg/m2     Poor socioeconomic status*     Low education status*     Malnutrition BMI <18.5 kg/m2*     Poor compliance with full antenatal care & and IFA consumption*     Smoking or substance abuse*     Life-changing events: death of a partner, divorce*		11–21/1000 7–13/1000 12–14/1000 13–18/1000
b. Pre-existing medical-surgical conditions     Chronic Hypertension     Diabetes Mellitus     Systemic Lupus Erythematosus     Renal Disease     Thyroid disease (uncontrolled)*     Anemia*		6–25/1000 6–35/1000 40–150/1000 15–200/1000
c. Pregnancy-associated complications     Preeclampsia         Without severe features         With severe features     Intrahepatic Cholestasis of Pregnancy     Fetal Growth Restriction     Multiple gestations     Oligohydramnios     Decreased fetal movements     Previous Stillbirth     Postdatism >41 weeks gestation     Pregnancy following ART		9–51/1000 12–29/1000 12–30/1000 10–47/1000 Twins 12/1000, Triplets 34/1000 14/1000 13/1000 9–20/1000 14-40/1000 12/1000

*The estimated risk of stillbirth is not available for these risk factors; however, there is a significant association with stillbirths

I.2 Interventions (Preconception/Antenatal) for prevention of stillbirth

I.2.a. Preconception interventions for reduction of stillbirths.[5,6,7,8]

• A detailed medical and obstetric history to determine the risk factors for stillbirth

• Careful review of previous records for the cause of the previous stillbirth if any

• Referral for genetic counseling if any genetic cause is suspected or identified in previous losses

• Advice on cessation of smoking, optimization of body mass index (BMI), and correction of anemia (Level 2; Grade B)

• Ensure optimization of maternal medical disorders such as chronic hypertension, diabetes mellitus, epilepsy, thyroid disorders, etc., including appropriate referral to specialists using a multidisciplinary team approach and for switching over to safer medications. (Level 2; Grade B, C)

• Start Tab aspirin [75–150 mg] preconceptionally in women with known anti-phospholipid antibody syndrome [APLA] or history suggestive of APLA. (Level 1; Grade A)

I.2.b. First trimester interventions for reduction of stillbirths.[5,7,9,10,11]

Offer an early ultrasound for accurate dating (first-trimester CRL measurement is most accurate) (Level 1; Grade)

• Nutritional risk assessment by BMI and Complete Blood Count (CBC).

• Perform screening for Gestational Diabetes Mellitus [GDM] (Level 1; Grade A) and thyroid disorders. (Level 2; Grade B).

• Offer first-trimester aneuploidy combined screening using Nuchal Translucency scan, serum beta hCG, and serum PAPP-A between 10 + 6 and 13 + 6 weeks of gestation. (Level 1; Grade A)

• Offer combined pre-eclampsia screening between 10 + 6 weeks and 13 + 6 weeks by identifying maternal risk factors, measuring mean arterial pressure [MAP], uterine artery pulsatility index [PI], PAPP-A, and PLGF levels as per availability. (Level 2; Grade B).

• Consider administration of Tab aspirin 75–150 mg to women screened positive for pre-eclampsia [PE][6] (Level 1; Grade A)

• Start low molecular weight heparin [LMWH] for women with APLA after documenting cardiac activity.[5,12] (Level 2; Grade A).

• Discuss and prepare an individualized care plan for each pregnancy including antenatal surveillance and timing of delivery.

II. MATERNAL MONITORING IN 2^ND AND 3^RD TRIMESTERS

II.1. Frequency of Antenatal check-ups

• A low-risk pregnant woman should have at least 8 antenatal visits with the first visit preferably in the first trimester then subsequent visits every month between 18 and 22 weeks, 24 and 26 weeks, 28 and 30 weeks, 32 and 34 weeks, and then every 2 weeks.[10,13,14] (Level 2; Grade B)

• Risk factors should be identified at each antenatal visit and communicated to the woman sensitively in a language that she understands.[13,15]

• When a risk factor for stillbirth is identified, optimize management according to the available clinical practice guidelines and tailor the frequency of visits according to her condition.[13]

II.2. Components of each Antenatal check-up (Monitoring and Interventions)

II.2.a. Nutrition and weight

• Identify and offer advice on under and overnutrition at first and subsequent visits.[1,3]

• Record maternal weight at every visit and advise on intended weight gain based on BMI class. Advise a weight gain of 12.5–18 kg for underweight women (BMI < 18.5 kg/m2), 11.5–16 kg for normal weight women (BMI 18.5–24.9 kg/m²), 7–11.5 kg for overweight women (BMI 25–29.9 kg/m²), and 5–9 kg for obese women (BMI > 30 kg/m²).[10,16,17]

II.2b. Ultrasound assessment

• Advise a fetal sonographic assessment at 18–22 weeks for structural defects, placental localization, and cervical length for all women. (Level 1; Grade A)

• Advise Uterine artery PI Doppler in women at risk of small for gestational age [SGA] baby or hypertensive disorders of pregnancy. Those detected to have an abnormal result should be followed up by serial USG for early detection of fetal growth restriction. (Level 2; Grade B)

• Advise fetal echocardiography at 24 weeks in women with a previous history of unexplained stillbirth or if high risk of fetal cardiac disorders in the present pregnancy as in diabetes mellitus and congenital heart disorder in the mother.

II.2.c. Screening for anemia

• Complete hemogram should be offered at the booking visit and 36 weeks. Repeat hemoglobin estimation at 28–30 weeks. (Anemia Mukt Bharat guidelines). (Level 2; Grade B)

II.2.d. Screening for asymptomatic bacteriuria

• Mid-stream urine culture at booking or registration visit, followed by adequate treatment if diagnosed.[10,18] (Level 2; Grade B)

II.2.e. Screening for STIs

• Screening and Counseling regarding prevention, screening, and management of sexually transmitted infections including HIV, HBsAg, and VDRL including risk of vertical transmission must be done at booking.

• Repeat the screening at term, especially for those at high risk of seroconversion.[10]

II.2.f. Screening for hypertensive disorders of pregnancy (HDP)

• Blood pressure should be measured at each visit by the correct technique in the sitting position with an appropriate cuff size.

• Ideally first-trimester combined screening and risk categorization for HDP should be done if facilities are available, and low-dose aspirin 150 mg/day at night is advised from 12 weeks for women at high risk of pre-eclampsia. In those reporting late in the second trimester clinical assessment for risk factors can be done and Aspirin can still be started if not started earlier.[12] (Level 1; Grade A)

II.2.g. Screening for Hyperglycemia

• Screen for diabetes mellitus at booking visit. (Level1/2; Grade A)

• For those screened negative in the first trimester, repeat screening at 24–28 weeks is indicated.[10,19]

II.2.h. Intrahepatic Cholestasis of pregnancy (IHCP) screening

• Enquire about the history of pruritis without any rash mainly on palms and soles suggestive of intrahepatic cholestasis and offer to test for bile acid and LFT.[13,15]

II.2.i. Smoking/tobacco use

• Elicit history of tobacco chewing, smoking, or passive smoking at every visit, and counsel regarding the associated risks.[15,20]

II.2.j. Awareness of fetal movements

• Pregnant women should be sensitized about the importance of being aware of the movements of their fetuses and advised to report to a health facility if they perceive any decrease in fetal movements (DFM), starting at 28 weeks onwards.[13,15]

• Care for women who report DFM, should be immediate and protocol-based.

II.2.k. Sleep position

• Women should be informed that after 28 weeks of pregnancy, going to sleep on their back is independently associated with late stillbirth. Going to sleep on the left or right side can reduce stillbirth by 5.8% in every pregnant woman after 28 weeks.[21] (Level1; Grade A)

II.2.l. Screening for intimate partner violence (IPV)

• Elicit history suggestive of intimate partner/family violence in a sensitive manner at each visit and counsel the woman and her partner regarding the impact on the fetus.[10,15,19]

II.2.m. Antenatal Anti D Immuno-prophylaxis

• Antenatal prophylaxis with anti-D immunoglobulin in non-sensitized Rh-negative pregnant women are advised at 28 weeks of gestation to prevent RhD alloimmunization.[10] (Level1; Grade A)

III. FETAL MONITORING IN 2^ND AND 3^RD TRIMESTERS

The objective is to identify fetuses with growth disorders (small and large for gestational age)

III.1. Optimal standard of care for low-risk mothers

• It is recommended to do serial measurements of symphysio-fundal height (SFH) in centimeters with measuring tape every 2–3 weeks and plot it on a customized growth chart and watch for consistent growth velocity on subsequent antenatal visits.[22,23] (Level2; Grade B)

• A growth scan in the third trimester is advised preferably between 35 + 0 and 36 + 6 weeks gestation for fetal biometry and EFW. Estimated fetal weight is more sensitive than fetal AC for the diagnosis of fetal growth restriction.[24] (Level 2; Grade B)

• The measured SFH or estimated fetal weight on ultrasound must be plotted on growth charts and expressed as a centile. It is best to use customized growth charts.[25] However, population-based charts like INTERGROWTH-21, and WHO growth charts, can be used if customized charts are not available.[26,27]

• Falling off the curve or slowing of the SFH trend should be a trigger to offer an ultrasound to assess the growth of fetus.

• Those detected as SGA must be assessed by Doppler flow studies.[22]

• In conditions like multiple fibroids, polyhydramnios, or high BMI, consider monitoring fetal growth by ultrasound as SFH is likely to be inaccurate.

III.2. Optimal standard of care for High-risk mothers

• Mothers with risk factors must be offered serial fetal growth assessment on ultrasound by fetal biometry and estimated fetal weight. An umbilical artery Doppler study should be initiated from 24–28 weeks of pregnancy for surveillance of SGA.[22] (Level 2; Grade B)

• All mothers should be advised of uterine artery Doppler at the time of the anomaly scan.[22]

III.3. Triggers for further investigations:

• A fundal height discordance of 4 weeks by palpatory method, or at least 3 cm by SFH measurement, or SFH less than 10^th centile or more than 90^th centile of expected value, when plotted on standard reference centile chart.

• Falling centile of EFW by more than 2 quartiles between ultrasound assessments at a gap of 3–4 weeks.[22]

• Oligohydramnios

• Patient reporting with decreased fetal movements

IV. MINDFETALNESS AND MANAGEMENT OF DECREASED FETAL MOVEMENTS

Mothers must be made aware of mindfetalness that is being aware of the quantity and quality of movements of their fetus, instead of maintaining a fetal kick count.[28] Decreased Fetal Movements (DFM) are associated with an increased risk of stillbirths and adverse pregnancy outcomes like preterm labor, fetal growth restriction (FGR), small for gestational age (SGA), congenital abnormalities, and feto-maternal hemorrhage especially recurrent episodes of DFM.[29,30,31]

• Mothers should be provided with verbal and written information about fetal movements (FM) by 28 weeks and the same should be reinforced at each antenatal visit. (Level 2; Grade B)

• They should be informed that alteration in FMs is a sign of fetal compromise though most mothers who experience decreased fetal movements give birth to a healthy child. They should be advised to report for urgent assessment if there is any decrease in strength and or frequency of fetal movements after 28 weeks of gestation or if she is unsure/uncertain about fetal movements.

• Any mother who reports a concern related to fetal movements whether reduced, weak, absent, or too vigorous; evaluation is required irrespective of whether she is carrying a low-risk or a high-risk pregnancy.[31] (Level 2; Grade A)

Stepwise Protocol for Management of Decreased Fetal Movements.[32,33,34]

1. A detailed history and review of antenatal records to identify any high-risk factors for stillbirth.

2. Clinical assessment of SFH to see if it corresponds to the period of gestation

3. Auscultation of the fetal heart preferably with a hand-held Doppler rather than a stethoscope so that mother can also hear the fetal heart sounds.

4. Get a CTG done within 30 minutes, if it is reassuring, USG is done in the next 24 hours if not already done in the previous 2 weeks.

5. Convey results of investigations to the mother, reassure her, and encourage her to report immediately if she has further concerns about decreased FM. Reassure her that she has done the right thing in presenting for assessment even if the assessment is normal.

6. In case FHS is not heard on auscultation arrange for immediate ultrasound assessment. if a fetal heart is present look for fetal growth, viability, and liquor volume, rule out gross congenital malformations, and perform umbilical artery Doppler flow studies.

7. If pregnancy is beyond 28+0 weeks and CTG is not available or if there is suspected FGR, recurrent decrease in FM, suspected feto-maternal hemorrhage etc. perform USG

• In low-risk pregnant women presenting at 37–39 weeks with recurrent decreased FM individualized care based on shared decision-making and written informed consent according to her gestational age should be provided.

• In low-risk women with recurrent decreased FM after 39 weeks; offer induction of labor and delivery.[35]

• Suspect feto-maternal hemorrhage: if there is a history of abdominal trauma, sinusoidal fetal heart rate pattern, fetal hydrops on USG, or abnormal MCA Doppleroffer testing for feto-maternal hemorrhage by Kleihauer test.[6]

V. MANAGEMENT OF LOW-RISK MOTHER DIAGNOSED WITH FETAL GROWTH RESTRICTION

• Confirm the dating of pregnancy and current gestational age whenever FGR is suspected.

• Confirm the diagnosis of FGR, by fetal biometry (AC), EFW, and Doppler flow studies and classify as per Delphi consensus. (Level 2; Grade A/B)

• Doppler flow studies must include the umbilical artery and middle cerebral artery in late-onset FGR, and the umbilical artery, uterine artery, and ductus venosus in early-onset FGR.

• Detailed sonographic assessment for any structural anomalies/soft markers or any signs of TORCH infections should be done in cases of severe and/or early onset FGR.

• Maternal screening for congenital infections like CMV and toxoplasmosis. Malaria, Rubella, Herpes, and Zika virus may be included in at-risk women.

• In women who have no apparent clinical risk factors for early onset FGR offer karyotyping followed by microarray if required irrespective of gestation age.

V.1. Monitoring

The main objective of fetal monitoring after the diagnosis of FGR is to provide a safety net against stillbirth. It is done to detect the fetus at risk of irreversible compromise so that timely delivery can be planned by balancing the risk of prematurity with the risk of Intrauterine Fetal Death (IUFD), neonatal mortality, and morbidity. The overall risk of stillbirth among FGR with abnormal Doppler flow study is high: AEDF 6.8% OR 3.6 [2.3–5.6], REDF 19% OR 7.3 [4.6–11.4] and abnormal DV 20%, OR 11.6 (6.3–19.7). However, with strict fetal surveillance, it can be reduced significantly (AEDF 0–1%, REDF 1–2%, abnormal DV 2–4%).[36,37,38]

Fetal surveillance tests include:

1. Awareness of fetal movements or Mindfetalness

2. Non-stress test (cardiotocography)

3. Ultrasound evaluation of fetal growth and amniotic fluid

4. Doppler ultrasound of the fetal arterial and venous circulation.

The frequency of antepartum surveillance and timing of delivery should be decided according to the severity of FGR, fetal Doppler changes, gestational age, and associated maternal complications [Table 2]. In women without any risk factors, the monitoring and management protocol should be determined by the Umbilical Artery Doppler findings.

Table 2.

Monitoring & timing of delivery of low-risk mother with FGR[4,23,34,36]

FGR		Antenatal Check-up		USG for EFW		Doppler		CTG/BPP		Delivery
EFW<3rd centile with normal Doppler & adequate liquor		Weekly		2 weeks		Weekly		Weekly		37 weeks
EFW 3-< 10th centile with normal Doppler & adequate liquor		Weekly		2 weeks		Weekly		Weekly		38–39 weeks
FGR with mild abnormalities     UA PI >95th centile     Or MCA PI <5th centile     Or CPR <5th centile     Or     Oligohydramnios     Or     Suboptimal interval growth		Twice a week Steroid cover		2 weeks		Weekly		1–2 times per week		37 weeks
FGR with AEDF/REDF		Inpatient monitoring Steroid cover		2 weeks		Every 1–2 days		1–2 times per day		AEDF 32–34 weeks REDF 30–32 weeks

V.2. Mode of Delivery

• Early FGR: Primary cesarean section can be offered in cases of FGR with AEDF/REDF or abnormal DV flow OR Induction of labor can be planned after explaining the risk of emergency cesarean as the fetus is already hypoxic and is less likely to tolerate the stress of labor.[36,39] (Level 2; Grade A/B)

• Late FGR: Vaginal delivery is the preferred mode and found successful in more than 80% of cases.[40,41]

• For Induction, mechanical methods should be preferred as they are safer compared to prostaglandins with less risk of cesarean section and intrapartum complications.

• Prostaglandins should be avoided and if necessary, use a reversible method like Dinoprostone vaginal pessary with careful monitoring for fetal well-being.[42] (Level 1; Grade A)

V.3. Intrapartum Monitoring and Place of Delivery

• Optimal intrapartum care using continuous electronic fetal monitoring is recommended once a woman is in labor.

• In low resource settings careful intermittent auscultation of the fetal heart post contraction every 15–30 min in the first stage and after every contraction in the second stage is advised. (Level 2; Grade B)

• Early rupture of membranes is recommended as it may help in the timely detection of meconium.

• Delivery should be planned at a place where facilities for emergency operative delivery and appropriate neonatal care are available.

Conflicts of interest

There are no conflicts of interest.

Funding Statement

Nil.