Document Detail


Failure of 17-hydroxyprogesterone to reduce neonatal morbidity or prolong triplet pregnancy: a double-blind, randomized clinical trial.
MedLine Citation:
PMID:  20816146     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To test whether 17 alpha-hydroxyprogesterone caproate (17P) will reduce neonatal morbidity by increasing gestational age at delivery in triplet pregnancies.
STUDY DESIGN: Double-blind, randomized clinical trial. Mothers carrying trichorionic-triamniotic triplets were randomly assigned (in a 2:1 ratio) to weekly injections of 250 mg of 17P or placebo, starting at 16-22 weeks and continued until 34 weeks. Primary outcome was composite neonatal morbidity.
RESULTS: Fifty-six women were randomized to 17P and 25 to placebo. Composite neonatal morbidity occurred with similar frequency in the 17P and placebo groups (38% vs 41%, respectively; P = .71). Mean gestational age at delivery was not affected by 17P (31.9 vs 31.8 weeks; P = .36). There were 13 midtrimester fetal losses with 17P vs none with placebo (P < .02).
CONCLUSION: In triplet pregnancy, prophylactic treatment with 17P did not reduce neonatal morbidity or prolong gestation but was associated with increased midtrimester fetal loss.
Authors:
C Andrew Combs; Thomas Garite; Kimberly Maurel; Anita Das; Manuel Porto;
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  American journal of obstetrics and gynecology     Volume:  203     ISSN:  1097-6868     ISO Abbreviation:  Am. J. Obstet. Gynecol.     Publication Date:  2010 Sep 
Date Detail:
Created Date:  2010-09-06     Completed Date:  2010-09-30     Revised Date:  2011-09-09    
Medline Journal Info:
Nlm Unique ID:  0370476     Medline TA:  Am J Obstet Gynecol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  248.e1-9     Citation Subset:  AIM; IM    
Copyright Information:
Copyright 2010 Mosby, Inc. All rights reserved.
Affiliation:
Obstetrix Medical Group, Sunrise, FL, USA.
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MeSH Terms
Descriptor/Qualifier:
17-alpha-Hydroxyprogesterone / therapeutic use*
Abortion, Spontaneous / epidemiology
Adult
Double-Blind Method
Female
Fetal Death / epidemiology
Gestational Age
Humans
Infant, Newborn
Infant, Newborn, Diseases / epidemiology
Pregnancy
Pregnancy Complications / epidemiology
Pregnancy, High-Risk*
Pregnancy, Multiple*
Premature Birth / prevention & control*
Triplets*
Chemical
Reg. No./Substance:
68-96-2/17-alpha-Hydroxyprogesterone
Investigator
Investigator/Affiliation:
Thomas Garite / ; C Andrew Combs / ; Kimberly Maurel / ; Diana Abril / ; Anita F Das / ; James Thorp / ; Michael Gravett / ; Paul Meis / ; John Elliott / ; Melissa Ingersoll / ; Ana Braescu / ; Cecilia Lyons / ; Michael Nageotte / ; Christine Preslicka / ; James Kurtzman / ; Ann McCann / ; David Luthy / ; Tina Lopez / ; Dawn Artis / ; Shawn Stallings / ; Lorrie Mason / ; Hugh Miller / ; Diane Mercer / ; Manuel Porto / ; Pamela Rumney / ; Richard Porreco / ; Leslie Harden / ; Maryanne Bruno / ; Greg Lindsay / ; Gwen DuBois / ; Kent Heybourne / ; Marilyn Hall / ; William Stettler / ; Diane Lucero / ; George Lu / ; Mary Jean Brown / ; Neil Mandsager / ; Amie Dawes / ; Denise Cope / ; Andrew Combs / ; Kimberly Mallory / ; Jon Rosnes / ; Kristine Jones / ; Bannie Tabor / ; Alaine McAfee / ; Mary Root / ; Harris Methodist / ; Martin Walker / ; SallyAnn deVitry Smith / ; Donald Roberts /
Comments/Corrections
Comment In:
Am J Obstet Gynecol. 2011 May;204(5):e16-7; author reply e17   [PMID:  21276949 ]
Erratum In:
Am J Obstet Gynecol. 2011 Feb;204(2):166

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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