Outcomes measures
stillbirth
ADVERSE EVENTS, PRETERM BIRTH, MISCARRIAGE, ADVERSE EVENT
In accordance with the trial protocol, low birth weight (primary outcome) was assessed by measuring birth weight within 24 h after birth by a trained nurse using a calibrated digital infant scale (Seca). Neonates were weighed when unclothed. Duplicate measurements were recorded to the nearest 10 g. If the two measurements differed by 10 g, a third measurement was obtained and the two closest values were averaged. Low birth weight was defined as birth weight of less than 2500 g [Secondary outcomes were preterm birth (a gestation age calculated from the gestational age estimated at the time of inclusion and which is < 37 weeks), stillbirth (birth at ≥ 28 weeks’ gestation with no signs of life), miscarriage (any pregnancy lost at < 28 weeks ‘gestation). Adverse events and serious adverse events were collected throughout the study.