Mieke L G Ten Eikelder1, Katrien Oude Rengerink2, Marta Jozwiak3, Jan W de Leeuw4, Irene M de Graaf2, Mariëlle G van Pampus5, Marloes Holswilder6, Martijn A Oudijk2, Gert-Jan van Baaren2, Paula J M Pernet7, Caroline Bax8, Gijs A van Unnik9, Gratia Martens10, Martina Porath11, Huib van Vliet12, Robbert J P Rijnders13, A Hanneke Feitsma14, Frans J M E Roumen15, Aren J van Loon16, Hans Versendaal17, Martin J N Weinans18, Mallory Woiski19, Erik van Beek20, Brenda Hermsen21, Ben Willem Mol22, Kitty W M Bloemenkamp23. 1. Department of Obstetrics, Leiden University Medical Centre, Leiden, Netherlands. Electronic address: m.teneikelder@gmail.com. 2. Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, Netherlands. 3. Department of Obstetrics, Leiden University Medical Centre, Leiden, Netherlands. 4. Department of Obstetrics and Gynaecology, Ikazia Hospital, Rotterdam, Netherlands. 5. Department of Obstetrics and Gynaecology, Onze Lieve Vrouwen Gasthuis, Amsterdam, Netherlands. 6. Department of Obstetrics and Gynaecology, University Medical Centre Groningen, Groningen, Netherlands. 7. Department of Obstetrics and Gynaecology, Kennemer Gasthuis, Haarlem, Netherlands. 8. Department of Obstetrics and Gynaecology, Vrije University Medical Centre, Amsterdam, Netherlands. 9. Department of Obstetrics and Gynaecology, Diaconessenhuis, Leiden, Netherlands. 10. Department of Obstetrics and Gynaecology, Zuwe Hofpoort, Woerden, Netherlands. 11. Department of Obstetrics and Gynaecology, Maxima Medical Centre, Veldhoven, Netherlands. 12. Department of Obstetrics and Gynaecology, Catharina Hospital, Eindhoven, Netherlands. 13. Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands. 14. Department of Obstetrics and Gynaecology, HAGA Hospital, Den Haag, Netherlands. 15. Department of Obstetrics and Gynaecology, Atrium Medical Centre, Heerlen, Netherlands. 16. Department of Obstetrics and Gynaecology, Martini Hospital, Groningen, Netherlands. 17. Department of Obstetrics and Gynaecology, Maasstad Hospital, Rotterdam, Netherlands. 18. Department of Obstetrics and Gynaecology, Gelderse Vallei Hospital, Ede, Netherlands. 19. Department of Obstetrics and Gynaecology, University Medical Centre Nijmegen, Nijmegen, Netherlands. 20. Department of Obstetrics and Gynaecology, St Antonius Hospital, Nieuwegein, Netherlands. 21. Department of Obstetrics and Gynaecology, St Lucas Andreas Hospital, Amsterdam, Netherlands. 22. The Robinson Research Institute, School of Paediatrics and Reproductive Health, University of Adelaide, Adelaide, SA, Australia; The South Australian Health and Medical Research Institute, Adelaide, SA, Australia. 23. Department of Obstetrics, Leiden University Medical Centre, Leiden, Netherlands; Wilhelmina Children's Hospital Birth Centre, University Medical Centre Utrecht, Utrecht, Netherlands.
Abstract
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 tooral misoprostoland 927 women toFoley 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 oralmisoprostol and Foley catheter has similar safety and effectiveness. FUNDING: FondsNutsOhra.
RCT Entities:
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.
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