Affiliation:
1. Department of Obstetrics and Gynecology Helsinki University Hospital and University of Helsinki Helsinki Finland
2. Department of Obstetrics and Gynecology Central Finland Central Hospital Jyväskylä Finland
3. Department of Obstetrics and Gynecology Kuopio University Hospital and University of Eastern Finland Kuopio Finland
4. Clinical Medicine Research Unit, Department of Obstetrics and Gynecology, Medical Research Center Oulu Oulu University Hospital and University of Oulu Oulu Finland
5. Department of Obstetrics and Gynecology Tampere University Hospital and Tampere University Tampere Finland
6. Department of Obstetrics and Gynecology Turku University Hospital and University of Turku Turku Finland
Abstract
AbstractIntroductionNeonatal and maternal risks increase in term pregnancy as gestational age advances and become increasingly evident post‐term. Management practices of late‐ and post‐term pregnancies vary, and the optimal time point for intervention by labor induction is yet to be determined.Material and methodsThis randomized controlled trial of 381 nulliparous women with unripe cervices compared labor induction at 41+0 gestational weeks (early induction) with expectant management and labor induction at 41+5 to 42+1 gestational weeks (expectant management). This multicenter study included all five university hospitals and the largest central hospital in Finland. The study period was 2018–2022. Participants were randomized to either early induction (48.8%, n = 186) or expectant management (51.2%, n = 195) with equal randomization ratios of 1:1. This was a superiority trial, and the primary outcomes were rates of cesarean section (CS) and composite of adverse neonatal outcomes. The trial was registered at the ISRCTN registry (ISRCTN83219789, https://doi.org/10.1186/ISRCTN83219789).ResultsThe rates of CS (16.7% [n = 31] vs. 24.1% [n = 47], RR 0.7 [95% CI: 0.5–1.0], p = 0.07) and a composite of adverse neonatal outcomes (9.7% [n = 18] vs. 14.4% [n = 28], RR 0.7 [95% CI: 0.4–1.2] p = 0.16) did not significantly differ between the groups, but the operative delivery rate was lower in the early induction group than in the expectant management group (30.6% [n = 57] vs. 45.6% [n = 89], p = 0.003). The rates of hemorrhage ≥1000 mL and neonatal weight ≥4000 g were also lower in the early induction group, as was the vacuum extraction rate in women with vaginal delivery. Of the women with expectant management, 45.6% (n = 89) had spontaneous onset of labor. No perinatal deaths occurred, but one case of eclampsia appeared in the expectant management group.ConclusionsOffering labor induction to nulliparous women at 41+0 gestational weeks may decrease the probability of operative delivery, postpartum hemorrhage, and neonatal weight ≥4000 g. However, this study was underpowered to affirm the trends of rising rates of CS and adverse neonatal outcomes in the expectant management group. Thus, expectant management could remain an option for some, as one in two women with expectant management had a spontaneous onset of labor.
Subject
Obstetrics and Gynecology,General Medicine