Progesterone vaginal gel for the reduction of recurrent preterm birth: primary results from a randomized, double‐blind, placebo‐controlled trial
Adult
premature labor
Abortion, Habitual
double blind procedure
Adolescent
recurrent disease
Pregnancy, High-Risk
610
morbidity
progesterone
618
Placebos
03 medical and health sciences
0302 clinical medicine
Double-Blind Method
Pregnancy
Humans
controlled study
human
gestational age
Progesterone
controlled clinical trial
Intravaginal
Vaginal Creams
article
Abortion
Pregnancy Outcome
risk assessment
clinical trial
Foams
major clinical study
mortality
Habitual
3. Good health
Administration, Intravaginal
female
and Jellies
priority journal
randomized controlled trial
Administration
Vaginal Creams, Foams, and Jellies
Premature Birth
High-Risk
Female
Progestins
Algorithms
DOI:
10.1002/uog.5158
Publication Date:
2007-09-26T16:52:58Z
AUTHORS (25)
ABSTRACT
AbstractObjectivePreterm 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.MethodsThis 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.ResultsBaseline 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.ConclusionProphylactic 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. Copyright © 2007 ISUOG. Published by John Wiley & Sons, Ltd.
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