Prospective data
death, abortion, miscarriages, stillbirths, deaths
MISCARRIAGES, MISCARRIAGE
We used prospectively collected data from a large, population-based randomized trial of topical applications for newborn massage, the Nepal Oil Massage Study (NOMS) (NCT01177111), which enrolled and followed pregnant women and their infants in 34 Village Development Committees (VDCs) in Sarlahi District, Nepal, between November 2010 and January 2017. At the start of the trial, data collectors conducted a census activity to systematically visit all households in the study area to update existing project maps and database. During the trial, data collectors monitored all married women 15–35 years through a pregnancy surveillance system. Local-resident-female data collectors visited women every 5 weeks to ask about the date of last menstrual period (LMP) and offer a pregnant test if needed. Pregnant women were enrolled in the study and followed monthly in pregnancy, as soon as possible after delivery, and through the neonatal period with visits on days 1, 3, 7, 10, 14, 21, and 28. The trial recorded 32,114 live births, 865 stillbirths, and 998 neonatal deaths.The trial collected baseline data on participants’ demographic characteristics, socioeconomic status, and pregnancy history. At the study visit following delivery, data collectors recorded the date/time of the pregnancy outcome, location of delivery, labor and delivery characteristics, health status of the mother and infant, and infant anthropometry (weight, length, head circumference, temperature). Data collectors asked participants if each pregnancy outcome was a miscarriage, abortion, live birth only, stillbirth only, or live birth(s) and stillbirth(s) (in cases of multiple gestation). We made a final classification between live birth and stillbirth based upon three questions: Did the baby ever cry? Did the baby ever move? Did the baby ever breathe? If the mother or caregiver answered yes to any of these questions, we classified the outcome as live birth; otherwise, we classified it as a fetal loss. We made a classification between miscarriages (< 28 weeks) and stillbirths (≥ 28 weeks) among fetal losses using the gestational age at delivery calculated from the LMP date, which was obtained at the time of enrollment, early in pregnancy. Data collectors administered a stillbirth verbal autopsy module to the mother or caregiver for this outcome. In cases of death of a liveborn infant, data collectors administered a neonatal verbal autopsy module.