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
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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