title: Prevention of preterm birth in triplets using 17 alpha-hydroxyprogesterone caproate: a randomized controlled trial.
abstract: OBJECTIVE
  To assess whether 17 alpha-hydroxyprogesterone caproate reduces the rate of preterm birth in women carrying triplets.
  
  
  METHODS
  We performed this randomized, double-blinded, placebo-controlled trial in 14 centers. Healthy women with triplets were randomly assigned to weekly intramuscular injections of either 250 mg of 17 alpha-hydroxyprogesterone caproate or matching placebo, starting at 16-20 weeks and ending at delivery or 35 weeks of gestation. The primary study outcome was delivery or fetal loss before 35 weeks.
  
  
  RESULTS
  One hundred thirty-four women were assigned, 71 to 17 alpha-hydroxyprogesterone caproate and 63 to placebo; none were lost to follow-up. Baseline demographic data were similar in the two groups. The proportion of women experiencing the primary outcome (a composite of delivery or fetal loss before 35 0/7 weeks) was similar in the two treatment groups: 83% of pregnancies in the 17 alpha-hydroxyprogesterone caproate group and 84% in the placebo group, relative risk 1.0, 95% confidence interval 0.9-1.1. The lack of benefit of 17 alpha-hydroxyprogesterone caproate was evident regardless of the conception method or whether a gestational age cutoff for delivery was set at 32 or 28 weeks.
  
  
  CONCLUSIONS
  Treatment with 17 alpha-hydroxyprogesterone caproate did not reduce the rate of preterm birth in women with triplet gestations.
  
  
  BACKGROUND
  ClinicalTrials.gov, www.clinicaltrials.gov, NCT00099164
  
  
  METHODS
  I.
authors.affiliation: Departments of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, PA 15213, USA. scaritis@mail.magee.edu
authors.forename: Steve N
authors.initials: SN
authors.lastname: Caritis
authors.forename: Dwight J
authors.initials: DJ
authors.lastname: Rouse
authors.forename: Alan M
authors.initials: AM
authors.lastname: Peaceman
authors.forename: Anthony
authors.initials: A
authors.lastname: Sciscione
authors.forename: Valerija
authors.initials: V
authors.lastname: Momirova
authors.forename: Catherine Y
authors.initials: CY
authors.lastname: Spong
authors.forename: Jay D
authors.initials: JD
authors.lastname: Iams
authors.forename: Ronald J
authors.initials: RJ
authors.lastname: Wapner
authors.forename: Michael
authors.initials: M
authors.lastname: Varner
authors.forename: Marshall
authors.initials: M
authors.lastname: Carpenter
authors.forename: Julie
authors.initials: J
authors.lastname: Lo
authors.forename: John
authors.initials: J
authors.lastname: Thorp
authors.forename: Brian M
authors.initials: BM
authors.lastname: Mercer
authors.forename: Yoram
authors.initials: Y
authors.lastname: Sorokin
authors.forename: Margaret
authors.initials: M
authors.lastname: Harper
authors.forename: Susan
authors.initials: S
authors.lastname: Ramin
authors.forename: Garland
authors.initials: G
authors.lastname: Anderson
mesh_terms: D000077713:17 alpha-Hydroxyprogesterone Caproate; D000328:Adult; D005260:Female; D006801:Humans; D006908:Hydroxyprogesterones / Q000008:administration & dosage*; D007273:Injections, Intramuscular; D011247:Pregnancy; D047928:Premature Birth / Q000517:prevention & control*; D011372:Progestins / Q000008:administration & dosage*; D012306:Risk; D017211:Treatment Failure; D014310:Triplets
chemical_list: D006908:Hydroxyprogesterones; D011372:Progestins; D000077713:17 alpha-Hydroxyprogesterone Caproate