title: 17α-hydroxyprogesterone caproate for the prevention of adverse neonatal outcome in multiple pregnancies: a randomized controlled trial.
abstract: OBJECTIVE
  To estimate whether administration of 17α-hydroxyprogesterone caproate can prevent neonatal morbidity in multiple pregnancies by reducing the preterm birth rate.
  
  
  METHODS
  We conducted a multicenter, double-blind, placebo-controlled randomized trial in 55 obstetric clinics in the Netherlands. Women with a multiple pregnancy were randomized to weekly injections of either 250 mg 17α-hydroxyprogesterone caproate or placebo, starting between 16 and 20 weeks of gestation and continuing until 36 weeks of gestation. The main outcome measure was adverse neonatal outcome. Secondary outcome measures were gestational age at delivery and delivery before 28, 32, and 37 weeks of gestation.
  
  
  RESULTS
  We randomized 671 women. A composite measure of adverse neonatal outcome was present in 110 children (16%) born to mothers in the 17α-hydroxyprogesterone caproate group, and in 80 children (12%) of mothers in the placebo group (relative risk [RR] 1.34; 95% confidence interval [CI] 0.95-1.89). The mean gestational age at delivery was 35.4 weeks for the 17α-hydroxyprogesterone caproate group and 35.7 weeks for the placebo group (P=.32). Treatment with 17α-hydroxyprogesterone caproate did not reduce the delivery rate before 28 weeks (6% in the 17α-hydroxyprogesterone caproate group compared with 5% in the placebo group, RR 1.04; 95% CI 0.56-1.94), 32 weeks (14% compared with 10%, RR 1.37; 95% CI 0.91-2.05), or 37 weeks of gestation (55% compared with 50%, RR 1.11; 95% CI 0.97-1.28).
  
  
  CONCLUSIONS
  17α-hydroxyprogesterone caproate does not prevent neonatal morbidity or preterm birth in multiple pregnancies.
  
  
  BACKGROUND
  ISRCTN Register, www.isrctn.org, ISRCTN40512715.
authors.affiliation: From the Departments of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam; Leiden University Medical Centre, Leiden; Tergooi Hospitals, Blaricum; Erasmus University Medical Centre, Rotterdam; University Medical Centre Groningen, Groningen; Isala Clinics, Zwolle; Catharina Hospital, Eindhoven; Medical Centre Alkmaar, Alkmaar; St. Antonius Hospital, Nieuwegein; University Medical Centre Utrecht, Utrecht; St. Elisabeth Hospital, Tilburg; Onze Lieve Vrouwe Gasthuis, Amsterdam; Amphia Hospital, Breda; Máxima Medical Centre, Veldhoven; St. Radboud University Medical Centre, Nijmegen; Maastricht University Medical Centre, Maastricht; and Nij Smellinghe Hospital, Drachten; and the Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands.
authors.forename: Arianne C
authors.initials: AC
authors.lastname: Lim
authors.forename: Ewoud
authors.initials: E
authors.lastname: Schuit
authors.forename: Kitty
authors.initials: K
authors.lastname: Bloemenkamp
authors.forename: Rob E
authors.initials: RE
authors.lastname: Bernardus
authors.forename: Johannes J
authors.initials: JJ
authors.lastname: Duvekot
authors.forename: Jan Jaap H M
authors.initials: JJHM
authors.lastname: Erwich
authors.forename: Jim
authors.initials: J
authors.lastname: van Eyck
authors.forename: Rolf H H
authors.initials: RHH
authors.lastname: Groenwold
authors.forename: Tom H M
authors.initials: THM
authors.lastname: Hasaart
authors.forename: Piet
authors.initials: P
authors.lastname: Hummel
authors.forename: Michael M
authors.initials: MM
authors.lastname: Kars
authors.forename: Anneke
authors.initials: A
authors.lastname: Kwee
authors.forename: Charlotte M
authors.initials: CM
authors.lastname: van Oirschot
authors.forename: Mariëlle G
authors.initials: MG
authors.lastname: van Pampus
authors.forename: Dimitri
authors.initials: D
authors.lastname: Papatsonis
authors.forename: Martina M
authors.initials: MM
authors.lastname: Porath
authors.forename: Marc E
authors.initials: ME
authors.lastname: Spaanderman
authors.forename: Christine
authors.initials: C
authors.lastname: Willekes
authors.forename: Janine
authors.initials: J
authors.lastname: Wilpshaar
authors.forename: Ben W J
authors.initials: BWJ
authors.lastname: Mol
authors.forename: Hein W
authors.initials: HW
authors.lastname: Bruinse
mesh_terms: D000077713:17 alpha-Hydroxyprogesterone Caproate; D000328:Adult; D002584:Cervix Uteri / Q000033:anatomy & histology; D004311:Double-Blind Method; D005260:Female; D005865:Gestational Age; D006801:Humans; D006908:Hydroxyprogesterones / Q000627:therapeutic use*; D007273:Injections, Intramuscular; D057194:Intention to Treat Analysis; D011247:Pregnancy; D011256:Pregnancy Outcome; D011262:Pregnancy Trimester, Second; D011272:Pregnancy, Multiple; D047928:Premature Birth / Q000517:prevention & control*; D045167:Progesterone Congeners / Q000627:therapeutic use*
chemical_list: D006908:Hydroxyprogesterones; D045167:Progesterone Congeners; D000077713:17 alpha-Hydroxyprogesterone Caproate