title: Induction of labour with a Foley catheter or oral misoprostol at term: the PROBAAT-II study, a multicentre randomised controlled trial.
abstract: BACKGROUND
  Induction of labour is a common obstetric procedure. At present, different methods are used for induction of labour in women with an unfavourable cervix. Recently, we showed that in term women with an unfavorable cervix the use of a Foley catheter in comparison with vaginal Prostaglandin E2 gel, results in a comparable vaginal delivery rate. A meta-analysis on the subject indicated lower rates of hyperstimulation, and probably as a sequel fewer cases of postpartum haemorrhage. Misoprostol (PgE1) is another type of prostaglandin frequently used for labour induction, recommended by the international federation of gynaecology and obstetrics (FIGO). Misoprostol can be administered by vaginal, rectal and oral route. There is evidence that oral administration results in less asphyxia and hyperstimulation than vaginal administration. At present, valid comparisons between oral misoprostol and Foley catheter are lacking. Therefore, we propose a randomised controlled trial comparing Foley catheter to oral misoprostol in order to assess safety and cost-effectiveness.
  
  
  METHODS
  We plan a multicentre, randomised, controlled, open-label clinical trial among term pregnant women with a vital singleton in cephalic presentation, unfavorable cervix, intact membranes and an indication for induction of labour. After informed consent, women will be randomly allocated by a webbased randomisation system to transcervical Foley catheter or oral misoprostol (50 mcg every 4 hours). The primary outcome will be a composite of complications of uterine hyperstimulation, i.e. post partum haemorrhage and asphyxia. Secondary outcomes are mode of delivery, maternal and neonatal morbidity, costs and women's preference. Serious adverse events such as severe maternal or neonatal morbitity or mortality will be monitored and reported to an independent data safety monitory board. With a sample size of 1860 women we will be able to demonstrate a 5% non-inferiority of the Foley catheter as compared to misoprostol for the composite outcome.
  
  
  CONCLUSIONS
  Worldwide, various methods are being used for labour induction. Results of the proposed trial will contribute to the answer which method of induction of labour is most safe, cost-effective, and patient friendly and will help to construct evidence based guidelines.
  
  
  BACKGROUND
  The Netherlands Trial Register NTR3466.
authors.affiliation: Department of Obstetrics K-6-P-35, Leiden University Medical Centre, P,O, Box 9600, Leiden 2300 RC, the Netherlands.
authors.forename: Mieke L G
authors.initials: ML
authors.lastname: Ten Eikelder
authors.forename: Femke
authors.initials: F
authors.lastname: Neervoort
authors.forename: Katrien
authors.initials: K
authors.lastname: Oude Rengerink
authors.forename: Gert J
authors.initials: GJ
authors.lastname: van Baaren
authors.forename: Marta
authors.initials: M
authors.lastname: Jozwiak
authors.forename: Jan-Willem
authors.initials: JW
authors.lastname: de Leeuw
authors.forename: Irene
authors.initials: I
authors.lastname: de Graaf
authors.forename: Maria G
authors.initials: MG
authors.lastname: van Pampus
authors.forename: Maureen
authors.initials: M
authors.lastname: Franssen
authors.forename: Martijn
authors.initials: M
authors.lastname: Oudijk
authors.forename: Paulien
authors.initials: P
authors.lastname: van der Salm
authors.forename: Mallory
authors.initials: M
authors.lastname: Woiski
authors.forename: Paula Jm
authors.initials: PJ
authors.lastname: Pernet
authors.forename: A Hanneke
authors.initials: AH
authors.lastname: Feitsma
authors.forename: Huib
authors.initials: H
authors.lastname: van Vliet
authors.forename: Martina
authors.initials: M
authors.lastname: Porath
authors.forename: Frans
authors.initials: F
authors.lastname: Roumen
authors.forename: Erik
authors.initials: E
authors.lastname: van Beek
authors.forename: Hans
authors.initials: H
authors.lastname: Versendaal
authors.forename: Marion
authors.initials: M
authors.lastname: Heres
authors.forename: Ben Willem J
authors.initials: BW
authors.lastname: Mol
authors.forename: Kitty W M
authors.initials: KW
authors.lastname: Bloemenkamp
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D001238:Asphyxia Neonatorum / Q000209:etiology; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007751:Labor, Induced / Q000379:methods*; D016595:Misoprostol / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D010120:Oxytocics / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D057240:Patient Preference; D006473:Postpartum Hemorrhage / Q000209:etiology; D011247:Pregnancy; D012107:Research Design; D014546:Urinary Catheterization / Q000009:adverse effects / Q000191:economics; D055815:Young Adult
chemical_list: D010120:Oxytocics; D016595:Misoprostol