TY - JOUR
T1 - Induction of labour at term with oral misoprostol versus a Foley catheter (PROBAAT-II)
T2 - A multicentre randomised controlled non-inferiority trial
AU - ten Eikelder, Mieke L G
AU - Oude Rengerink, Katrien
AU - Jozwiak, Marta
AU - de Leeuw, Jan W.
AU - de Graaf, Irene M.
AU - van Pampus, Mariëlle G.
AU - Holswilder, Marloes
AU - Oudijk, Martijn A.
AU - van Baaren, Gert Jan
AU - Pernet, Paula J M
AU - Bax, Caroline
AU - van Unnik, Gijs A.
AU - Martens, Gratia
AU - Porath, Martina
AU - van Vliet, Huib
AU - Rijnders, Robbert J P
AU - Feitsma, A. Hanneke
AU - Roumen, Frans J M E
AU - van Loon, Aren J.
AU - Versendaal, Hans
AU - Weinans, Martin J N
AU - Woiski, Mallory
AU - van Beek, Erik
AU - Hermsen, Brenda
AU - Mol, Ben Willem
AU - Bloemenkamp, Kitty W M
N1 - Copyright © 2016 Elsevier Ltd. All rights reserved.
PY - 2016/4
Y1 - 2016/4
N2 - 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 μg 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.
AB - 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 μg 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.
UR - https://www.scopus.com/pages/publications/84956648484
U2 - 10.1016/S0140-6736(16)00084-2
DO - 10.1016/S0140-6736(16)00084-2
M3 - Article
C2 - 26850983
SN - 0140-6736
VL - 387
SP - 1619
EP - 1628
JO - The Lancet
JF - The Lancet
IS - 10028
ER -