title: Induction of labour at term with oral misoprostol versus a Foley catheter (PROBAAT-II): a multicentre randomised controlled non-inferiority trial.
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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  In women with an unfavourable cervix at term, induction of labour with oral misoprostol and Foley catheter has similar safety and effectiveness.
  
  
  BACKGROUND
  FondsNutsOhra.
authors: Department of Obstetrics, Leiden University Medical Centre, Leiden, Netherlands. Electronic address: m.teneikelder@gmail.com.
authors: Mieke L G
authors: ML
authors: Ten Eikelder
authors: Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, Netherlands.
authors: Katrien
authors: K
authors: Oude Rengerink
authors: Department of Obstetrics, Leiden University Medical Centre, Leiden, Netherlands.
authors: Marta
authors: M
authors: Jozwiak
authors: Department of Obstetrics and Gynaecology, Ikazia Hospital, Rotterdam, Netherlands.
authors: Jan W
authors: JW
authors: de Leeuw
authors: Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, Netherlands.
authors: Irene M
authors: IM
authors: de Graaf
authors: Department of Obstetrics and Gynaecology, Onze Lieve Vrouwen Gasthuis, Amsterdam, Netherlands.
authors: Mariëlle G
authors: MG
authors: van Pampus
authors: Department of Obstetrics and Gynaecology, University Medical Centre Groningen, Groningen, Netherlands.
authors: Marloes
authors: M
authors: Holswilder
authors: Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, Netherlands.
authors: Martijn A
authors: MA
authors: Oudijk
authors: Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, Netherlands.
authors: Gert-Jan
authors: GJ
authors: van Baaren
authors: Department of Obstetrics and Gynaecology, Kennemer Gasthuis, Haarlem, Netherlands.
authors: Paula J M
authors: PJ
authors: Pernet
authors: Department of Obstetrics and Gynaecology, Vrije University Medical Centre, Amsterdam, Netherlands.
authors: Caroline
authors: C
authors: Bax
authors: Department of Obstetrics and Gynaecology, Diaconessenhuis, Leiden, Netherlands.
authors: Gijs A
authors: GA
authors: van Unnik
authors: Department of Obstetrics and Gynaecology, Zuwe Hofpoort, Woerden, Netherlands.
authors: Gratia
authors: G
authors: Martens
authors: Department of Obstetrics and Gynaecology, Maxima Medical Centre, Veldhoven, Netherlands.
authors: Martina
authors: M
authors: Porath
authors: Department of Obstetrics and Gynaecology, Catharina Hospital, Eindhoven, Netherlands.
authors: Huib
authors: H
authors: van Vliet
authors: Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands.
authors: Robbert J P
authors: RJ
authors: Rijnders
authors: Department of Obstetrics and Gynaecology, HAGA Hospital, Den Haag, Netherlands.
authors: A Hanneke
authors: AH
authors: Feitsma
authors: Department of Obstetrics and Gynaecology, Atrium Medical Centre, Heerlen, Netherlands.
authors: Frans J M E
authors: FJ
authors: Roumen
authors: Department of Obstetrics and Gynaecology, Martini Hospital, Groningen, Netherlands.
authors: Aren J
authors: AJ
authors: van Loon
authors: Department of Obstetrics and Gynaecology, Maasstad Hospital, Rotterdam, Netherlands.
authors: Hans
authors: H
authors: Versendaal
authors: Department of Obstetrics and Gynaecology, Gelderse Vallei Hospital, Ede, Netherlands.
authors: Martin J N
authors: MJ
authors: Weinans
authors: Department of Obstetrics and Gynaecology, University Medical Centre Nijmegen, Nijmegen, Netherlands.
authors: Mallory
authors: M
authors: Woiski
authors: Department of Obstetrics and Gynaecology, St Antonius Hospital, Nieuwegein, Netherlands.
authors: Erik
authors: E
authors: van Beek
authors: Department of Obstetrics and Gynaecology, St Lucas Andreas Hospital, Amsterdam, Netherlands.
authors: Brenda
authors: B
authors: Hermsen
authors: 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.
authors: Ben Willem
authors: BW
authors: Mol
authors: Department of Obstetrics, Leiden University Medical Centre, Leiden, Netherlands; Wilhelmina Children's Hospital Birth Centre, University Medical Centre Utrecht, Utrecht, Netherlands.
authors: Kitty W M
authors: KW
authors: Bloemenkamp
mesh_terms: D000284:Administration, Oral; D000328:Adult; D001034:Apgar Score; D001238:Asphyxia Neonatorum / Q000209:etiology; D002404:Catheterization / Q000009:adverse effects / Q000379:methods*; D020070:Cervical Ripening / Q000187:drug effects; D036861:Delivery, Obstetric / Q000379:methods; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007751:Labor, Induced / Q000009:adverse effects / Q000379:methods*; D016595:Misoprostol / Q000008:administration & dosage* / Q000009:adverse effects; D010120:Oxytocics / Q000008:administration & dosage* / Q000009:adverse effects; D006473:Postpartum Hemorrhage / Q000209:etiology; D011247:Pregnancy; D047929:Term Birth; D014546:Urinary Catheterization / Q000295:instrumentation
chemical_list: D010120:Oxytocics; D016595:Misoprostol