Induction of labour at term with oral misoprostol versus a Foley catheter (PROBAAT-II): a multicentre randomised controlled non-inferiority trial
SourceThe Lancet (London), 387, 10028, (2016), pp. 1619-1628
Article / Letter to editor
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The Lancet (London)
SubjectRadboudumc 0: Other Research RIHS: Radboud Institute for Health Sciences
BACKGROUND: Labour is induced in 20-30% of all pregnancies. In women with an unfavourable cervix, both oral misoprostol and Foley catheter are equally effective compared with dinoprostone in establishing vaginal birth, but each has a better safety profile. We did a trial to directly compare oral misoprostol with Foley catheter alone. METHODS: We did an open-label randomised non-inferiority trial in 29 hospitals in the Netherlands. Women with a term singleton pregnancy in cephalic presentation, an unfavourable cervix, intact membranes, and without a previous caesarean section who were scheduled for induction of labour were randomly allocated to cervical ripening with 50 mug oral misoprostol once every 4 h or to a 30 mL transcervical Foley catheter. The primary outcome was a composite of asphyxia (pH </=7.05 or 5-min Apgar score <7) or post-partum haemorrhage (>/=1000 mL). The non-inferiority margin was 5%. The trial is registered with the Netherlands Trial Register, NTR3466. FINDINGS: Between July, 2012, and October, 2013, we randomly assigned 932 women to oral misoprostol and 927 women to Foley catheter. The composite primary outcome occurred in 113 (12.2%) of 924 participants in the misoprostol group versus 106 (11.5%) of 921 in the Foley catheter group (adjusted relative risk 1.06, 90% CI 0.86-1.31). Caesarean section occurred in 155 (16.8%) women versus 185 (20.1%; relative risk 0.84, 95% CI 0.69-1.02, p=0.067). 27 adverse events were reported in the misoprostol group versus 25 in the Foley catheter group. None were directly related to the study procedure. INTERPRETATION: In women with an unfavourable cervix at term, induction of labour with oral misoprostol and Foley catheter has similar safety and effectiveness. FUNDING: FondsNutsOhra.
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