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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Progesterone vaginal gel for the reduction of recurrent preterm birth: Primary results from a randomized, double-blind, placebo-controlled trial
Ultrasound in Obstetrics and Gynecology, Volume 30, No. 5, Year 2007
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Description
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. Conclusion: 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. Copyright © 2007 ISUOG. Published by John Wiley & Sons, Ltd.
Authors & Co-Authors
O'Brien, John M.
United States, Lexington
Central Baptist Hospital
Adair, Charles David
United States, Chattanooga
University of Tennessee College of Medicine Chattanooga
Lewis, David F.
United States, Shreveport
Lsu Health Sciences Center - Shreveport
Hall, David R.
South Africa, Tygerberg
Tygerberg Hospital
DeFranco, Emily A.
United States, St. Louis
Washington University School of Medicine in St. Louis
Fusey, Shalini S.
India, Nagpur
Government Medical College Nagpur
Soma-Pillay, Priya S.
South Africa, Pretoria
University of Pretoria
Porter, Kathy B.D.
United States, Mobile
University of South Alabama
How, Helen Y.
United States, Cincinnati
University of Cincinnati
Schackis, R. C.
South Africa, Johannesburg
Chris Hani Baragwanath Hospital
Eller, Daniel P.
United States, Atlanta
Maternal Fetal Specialists
Trivedi, Yamini N.
India, Ahmedabad
V.s. Hospital
VanBuren, George
United States, Cleveland
University Hospitals Case Medical Center
Khandelwal, Meena
United States, Camden
Cooper University Hospital
Trofatter, Kenneth F.
United States, Greenville
University Medical Group
Vidyadhari, D.
India, Hyderabad
Mediciti Institute of Medical Sciences
Vijayaraghavan, Jaya
India, Chennai
Sri Ramachandra Institute of Higher Education and Research
Weeks, Jonathan W.
United States, Louisville
Norton Healthcare
Dattel, Bonnie J.
United States, Norfolk
Eastern Virginia Medical School
Newton, Edward R.
United States, Greenville
The Brody School of Medicine
Chazotte, Cynthia
United States, New York
Albert Einstein College of Medicine of Yeshiva University
Valenzuela, Guillermo J.
United States, Colton
Arrowhead Regional Medical Center
Calda, P.
Czech Republic, Prague
Charles University
Bsharat, M.
United States, Durham
Iqvia Inc.
Creasy, George W.
United States, Livingston
Columbia Laboratories, Inc.
Statistics
Citations: 291
Authors: 25
Affiliations: 25
Identifiers
Doi:
10.1002/uog.5158
ISSN:
09607692
e-ISSN:
14690705
Research Areas
Disability
Maternal And Child Health
Participants Gender
Female