title: Progesterone vaginal gel for the reduction of recurrent preterm birth: primary results from a randomized, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  Preterm birth is the leading cause of perinatal morbidity and mortality worldwide. Treatment of preterm labor with tocolysis has not been successful in improving infant outcome. The administration of progesterone and related compounds has been proposed as a strategy to prevent preterm birth. The objective of this trial was to determine whether prophylactic administration of vaginal progesterone reduces the risk of preterm birth in women with a history of spontaneous preterm birth.
  
  
  METHODS
  This randomized, double-blind, placebo- controlled, multinational trial enrolled and randomized 659 pregnant women with a history of spontaneous preterm birth. Between 18 + 0 and 22 + 6 weeks of gestation, patients were assigned randomly to once-daily treatment with either progesterone vaginal gel or placebo until either delivery, 37 weeks' gestation or development of preterm rupture of membranes. The primary outcome was preterm birth at </= 32 weeks of gestation. The trial was analyzed using an intent-to-treat strategy.
  
  
  RESULTS
  Baseline characteristics were similar in the two treatment groups. Progesterone did not decrease the frequency of preterm birth at </= 32 weeks. There was no difference between the groups with respect to the mean gestational age at delivery, infant morbidity or mortality or other maternal or neonatal outcome measures. Adverse events during the course of treatment were similar for the two groups.
  
  
  CONCLUSIONS
  Prophylactic treatment with vaginal progesterone did not reduce the frequency of recurrent preterm birth (</= 32 weeks) in women with a history of spontaneous preterm birth. The effect of progesterone administration in patients at high risk for preterm delivery as determined by methods other than history alone (e.g. sonographic cervical length) requires further investigation.
authors: Perinatal Diagnostic Center, Central Baptist Hospital, Lexington, Kentucky, USA. jobrien@bhsi.com
authors: J M
authors: JM
authors: O'Brien
authors: C D
authors: CD
authors: Adair
authors: D F
authors: DF
authors: Lewis
authors: D R
authors: DR
authors: Hall
authors: E A
authors: EA
authors: Defranco
authors: S
authors: S
authors: Fusey
authors: P
authors: P
authors: Soma-Pillay
authors: K
authors: K
authors: Porter
authors: H
authors: H
authors: How
authors: R
authors: R
authors: Schackis
authors: D
authors: D
authors: Eller
authors: Y
authors: Y
authors: Trivedi
authors: G
authors: G
authors: Vanburen
authors: M
authors: M
authors: Khandelwal
authors: K
authors: K
authors: Trofatter
authors: D
authors: D
authors: Vidyadhari
authors: J
authors: J
authors: Vijayaraghavan
authors: J
authors: J
authors: Weeks
authors: B
authors: B
authors: Dattel
authors: E
authors: E
authors: Newton
authors: C
authors: C
authors: Chazotte
authors: G
authors: G
authors: Valenzuela
authors: P
authors: P
authors: Calda
authors: M
authors: M
authors: Bsharat
authors: G W
authors: GW
authors: Creasy
mesh_terms: D000026:Abortion, Habitual / Q000517:prevention & control*; D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D000465:Algorithms; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D010919:Placebos; D011247:Pregnancy; D011256:Pregnancy Outcome; D018566:Pregnancy, High-Risk; D047928:Premature Birth / Q000517:prevention & control*; D011374:Progesterone / Q000008:administration & dosage*; D011372:Progestins / Q000008:administration & dosage*; D014622:Vaginal Creams, Foams, and Jellies
chemical_list: D010919:Placebos; D011372:Progestins; D014622:Vaginal Creams, Foams, and Jellies; D011374:Progesterone