title: Induction of labour in pre-eclamptic women: a randomised trial comparing the Foley balloon catheter with oral misoprostol.
abstract: BACKGROUND
  Between 40,000 and 80,000 pregnant women die annually from pre-eclampsia and eclampsia. Although magnesium sulphate and anti-hypertensive therapies can reduce the morbidity and mortality associated with pre-eclampsia, the only cure comes with delivery. Prompt delivery of the baby, preferably by vaginal route, is vital in order to achieve good maternal and neonatal outcomes. Induction of labour is therefore a critical intervention in order to prevent morbidity to both mother and baby. Two low cost interventions - oral misoprostol tablets and transcervical Foley catheterization - are already used by some in low resource settings, but their relative risks and benefits are not known. The trial will compare the risks, benefits, and trade-offs in efficacy, safety, acceptability and cost of misoprostol and Foley catheter for induction in women with preeclampsia or uncontrolled hypertension.
  
  
  METHODS
  A total of 602 women with an ongoing pregnancy with a live fetus requiring delivery because of pre-eclampsia or uncontrolled hypertension will be randomly assigned to labor induction with a transcervical Foley catheter or oral misoprostol 25 micrograms. Women will be recruited at two hospitals in Nagpur, India. The misoprostol group will receive oral misoprostol 25 microgram every 2 hours for a maximum of 12 doses or until active labor commences. The Foley group will undergo induction using a Foley catheter (silicone, size 18 F with 30 ml balloon) which will remain until active labor starts, the Foley catheter falls out, or 12 hours have elapsed. The primary outcome will be the attainment of vaginal delivery within 24 hours. Providers administering the treatment and those assessing the outcomes will not be blinded to group assignment.
  
  
  BACKGROUND
  NCT01801410 (ClinicalTrials.gov).
authors.affiliation: Gynuity Health Projects, 15 East 26th Street, Suite 801, New York, NY 10010, USA. hbracken@gynuity.org.
authors.forename: Hillary
authors.initials: H
authors.lastname: Bracken
authors.forename: Shuchita
authors.initials: S
authors.lastname: Mundle
authors.forename: Brian
authors.initials: B
authors.lastname: Faragher
authors.forename: Thomas
authors.initials: T
authors.lastname: Easterling
authors.forename: Alan
authors.initials: A
authors.lastname: Haycox
authors.forename: Mark
authors.initials: M
authors.lastname: Turner
authors.forename: Zarko
authors.initials: Z
authors.lastname: Alfirevic
authors.forename: Beverly
authors.initials: B
authors.lastname: Winikoff
authors.forename: Andrew
authors.initials: A
authors.lastname: Weeks
mesh_terms: D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D002404:Catheterization / Q000379:methods*; D020070:Cervical Ripening / Q000502:physiology; D016001:Confidence Intervals; D005260:Female; D005500:Follow-Up Studies; D005865:Gestational Age; D006801:Humans; D007751:Labor, Induced / Q000379:methods*; D016015:Logistic Models; D016595:Misoprostol / Q000008:administration & dosage*; D010120:Oxytocics / Q000008:administration & dosage*; D061214:Patient Safety; D016012:Poisson Distribution; D011225:Pre-Eclampsia / Q000503:physiopathology* / Q000628:therapy; D011247:Pregnancy; D011256:Pregnancy Outcome; D011446:Prospective Studies; D018570:Risk Assessment; D016896:Treatment Outcome; D014546:Urinary Catheterization; D055815:Young Adult
chemical_list: D010120:Oxytocics; D016595:Misoprostol