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Background: The COVID-19 pandemic response is affecting maternal and neonatal health services all over the world. We aimed to assess the number of institutional births, their outcomes (institutional stillbirth and neonatal mortality rate), and quality of intrapartum care before and during the national COVID-19 lockdown in Nepal. Methods: In this prospective observational study, we collected participant-level data for pregnant women enrolled in the SUSTAIN and REFINE studies between Jan 1 and May 30, 2020, from nine hospitals in Nepal. This period included 12·5 weeks before the national lockdown and 9·5 weeks during the lockdown. Women were eligible for inclusion if they had a gestational age of 22 weeks or more, a fetal heart sound at time of admission, and consented to inclusion. Women who had multiple births and their babies were excluded. We collected information on demographic and obstetric characteristics via extraction from case notes and health worker performance via direct observation by independent clinical researchers. We used regression analyses to assess changes in the number of institutional births, quality of care, and mortality before lockdown versus during lockdown. Findings: Of 22 907 eligible women, 21 763 women were enrolled and 20 354 gave birth, and health worker performance was recorded for 10 543 births. From the beginning to the end of the study period, the mean weekly number of births decreased from 1261·1 births (SE 66·1) before lockdown to 651·4 births (49·9) during lockdown—a reduction of 52·4%. The institutional stillbirth rate increased from 14 per 1000 total births before lockdown to 21 per 1000 total births during lockdown (p=0·0002), and institutional neonatal mortality increased from 13 per 1000 livebirths to 40 per 1000 livebirths (p=0·0022). In terms of quality of care, intrapartum fetal heart rate monitoring decreased by 13·4% (−15·4 to −11·3; p<0·0001), and breastfeeding within 1 h of birth decreased by 3·5% (−4·6 to −2·6; p=0·0032). The immediate newborn care practice of placing the baby skin-to-skin with their mother increased by 13·2% (12·1 to 14·5; p<0·0001), and health workers' hand hygiene practices during childbirth increased by 12·9% (11·8 to 13·9) during lockdown (p<0·0001). Interpretation: Institutional childbirth reduced by more than half during lockdown, with increases in institutional stillbirth rate and neonatal mortality, and decreases in quality of care. Some behaviours improved, notably hand hygiene and keeping the baby skin-to-skin with their mother. An urgent need exists to protect access to high quality intrapartum care and prevent excess deaths for the most vulnerable health system users during this pandemic period. Funding: Grand Challenges Canada.
This is a prospective, observational study nested within two quality improvement studies, REFINE (ISRCTN16741720) and SUSTAIN (ISRCTN18148368), being done in nine health institutions in Nepal to implement a safer birth bundle package for 24 months (from January, 2019, to December, 2020; appendix 3 p 3).16 We report data over a period of 5 months including 12·5 weeks before lockdown implementation (Jan 1–March 20, 2020) and 9·5 weeks during lockdown (March 21–May 30, 2020). The nine hospitals were distributed across all seven provinces of the country (appendix 3 p 11). The annual number of births in these nine hospitals covered 11·2% of the national number of births for 2019.16 The hospitals in the study provided referral obstetric services through Comprehensive and Emergency Obstetrics and Neonatal Care services. All vaginal births took place in delivery units and caesarean births took place in operating theatres. At these nine hospitals, during the study period, no cases of COVID-19 were reported before lockdown and 1401 cases were reported during lockdown, but no cases were reported among pregnant women. There was no closure of any of the nine hospitals in the study as a result of reporting COVID-19 cases during the study period. Participants who consented and were enrolled in the REFINE and SUSTAIN studies were considered for this study. Women at 22 weeks of gestation or more admitted in the labour room and whose fetal heart sound was heard at the time of admission were eligible for inclusion. For use of the participant-level data for this study, additional approval was sought from the ethical review board of Nepal Health Research Council (registration number 439/2020). For this study, we excluded women who had multiple births and their babies. Participants provided informed written consent at the time of admission to the hospital. The SUSTAIN and REFINE studies were granted ethical approval by the ethical review board of Nepal Health Research Council. We extracted participant-level data from the existing data collection systems for the REFINE and SUSTAIN studies. For these studies, a validated clinical observation checklist was used to observe the labour and delivery event for all vaginal births possible, and women's obstetric and neonatal information was collected from patient case notes. A data collection system was set up at each hospital and observations were done by independent clinical researchers using a tablet-based application. All the data entered in the tablet-based application were reviewed on a weekly basis by an independent database manager. For this study, data were extracted by OB into SPSS software (version 17.0) for cleaning of extracted data of all births and observed data from all vaginal births. Institutional stillbirth rate was defined as the number of babies born in the institution with no signs of life, with a gestational age of 22 weeks or more, per 1000 births. Institutional neonatal mortality rate was defined as the number of neonates who died before discharge per 1000 livebirths. The health worker's performance during intrapartum care was measured on the basis of WHO's 2016 Standards for improving quality of maternal and newborn care in health facilities quality of care statement and process of care.17 The nine components of these standards are (1) health worker's handwashing practice during childbirth, defined as health-care staff who cleaned their hands correctly as per WHO's five moments for hand hygiene; (2) health worker's use of gloves and gown to reduce infection transmission during childbirth; (3) preparation of equipment to be used during childbirth; (4) health worker greeting the mother at the time of admission; (5) women having a companion during labour; (6) intrapartum fetal heart rate monitoring at 30 min intervals; (7) neonate's cord clamped 1 min after birth; (8) neonatal skin-to-skin contact with mother after birth; and (9) breastfeeding within 1 h of birth. For sociodemographic characteristics, ethnicity was recorded on the basis of the caste system in Nepal (ie, relatively disadvantaged ethnic groups [Janajati, Madeshi, Muslim, Dalit] and relatively advantaged ethnic groups [Brahmin and Chhetri-Hill, and Brahmin-Tarai]).18 We report women's age as mean (SD) and categorised as 18 years or younger, 19–24 years, 25–29 years, 30–34 years, and 35 years or older. Parity was defined as no previous births, at least one previous birth, or two or more previous births. Obstetric characteristic measurements included were complication at the time of admission, induced labour, and mode of birth, including spontaneous vaginal birth, assisted vaginal birth, and caesarean birth. For neonatal characteristics, we captured preterm birth (defined as <37 weeks of gestation on the basis of first day of mother's last menstrual period), low birthweight (≤2500 g), and sex of the baby (boy, girl, or ambiguous). We compared demographic, obstetric, and neonatal characteristics before and during lockdown using Pearson's χ2 test. We analysed the coverage of health worker's performance before and during lockdown using Pearson's χ2 test. To measure the weekly change in the number of births, we used a segmented time series model. We checked for autocorrelation using the autocorrelation factor for the outcome variable and found no significant autocorrelation.19 We used a generalised linear model with Poisson distribution and log-link function to calculate the risk of preterm birth, institutional stillbirth, and institutional neonatal mortality before and during lockdown. We adjusted for ethnicity, maternal age, and obstetric characteristics to calculate the risk of preterm birth, institutional stillbirth, and institutional neonatal mortality. We assessed the between-hospital heterogeneity on preterm birth, institutional stillbirth, and institutional neonatal mortality. We compared the weekly trend in the number of institutional births between January and May, 2019, and between January and May, 2020, to assess the difference between the two different time periods. To assess trends in outcome variables and health worker performance before and during the COVID-19 lockdown, we used locally weighted scatterplot smoothing regression analysis. We imputed missing values for gestational age using the Classification and Regression Tree method in the mice package in R. We did all data analyses using R (version 3.6.2). The funder of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the manuscript. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.
