Use of progest reduce prete.pdf

This document reflects emergingclinical and scientific advances as of the date issued and is subjectto change. The information ABSTRACT: Preterm birth affects 12% of all births in the United States. Recent studies support the hypothesis that progesterone supplementation ing an exclusive course of treat-ment or procedure to be reduces preterm birth in a select group of women (ie, those with a prior spon- taneous birth at <37 weeks of gestation). Despite the apparent benefits ofprogesterone in this high-risk population, the ideal progesterone formulation is unknown. The American College of Obstetricians and Gynecologists Committee on Obstetric Practice believes that further studies are needed to evaluate the use of progesterone in patients with other high-risk obstetric fac- All rights reserved. No part ofthis publication may be repro- tors, such as multiple gestations, short cervical length, or positive test results for cervicovaginal fetal fibronectin. When progesterone is used, it is important to restrict its use to only women with a documented history of a previous spon- taneous birth at less than 37 weeks of gestation because unresolved issues remain, such as optimal route of drug delivery and long-term safety of the drug. recording, or otherwise, withoutprior written permission from the Preterm birth affects 12% of all births in the United States. This statistic has led multiple investigators to identify those women at greatest risk (eg, those with prior preterm delivery, maternal weight <50 kg, African-American race, bleeding, and concurrent sexually transmitted diseases). Despite identifica- tion of these risk factors, no interventions to date have been associated with a decrease in preterm delivery rates.
A recent large randomized placebo-controlled trial comparing 17α hydroxyprogesterone caproate “17P” therapy to prevent preterm birth in a select, high-risk group of women (documented history of a previous sponta- neous preterm birth <37 weeks of gestation) was conducted for the NationalInstitute of Child Health and Human Development (NICHD) Maternal-Fetal The American College of
Obstetricians and Gynecologists
Medicine Units Network (1). A total of 459 women with a history of previ- ous spontaneous births at less than 37 weeks of gestation were enrolled between 16 weeks and 20 weeks of gestation. Of note, the mean gestational age of their previous preterm deliveries was 30.7 weeks. They were random-ly assigned to receive weekly intramuscular injections of 17P (n = 306) or placebo (n = 153). The study was stopped early when results showed a sig- Use of progesterone to reduce pretermbirth. ACOG Committee Opinion No.
nificant protection against recurrent preterm birth for all races of women who A recent small randomized placebo-controlled trial of supplemental vagi- nal progesterone (100 mg daily) in 142 women at high risk for preterm birth Table 1. Rates of Preterm Labor with Progesterone Therapy or Placebo
Gestation
Placebo Group (n = 153)
Progesterone Group (n = 306)
Relative Risk
Confidence Interval
Data from Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai B, Moawad AH, et al. Prevention of recurrent preterm delivery by 17 alpha-hydroxy-progesterone caproate. N Engl J Med 2003;348:2379–85.
(women with at least 1 previous spontaneous the use of progesterone in patients with other high- preterm birth, prophylactic cervical cerclage, and risk obstetric factors, such as multiple gestations, uterine malformation) revealed that for delivery at short cervical length, or positive test results for cer- less than 34 weeks of gestation, the preterm birth vicovaginal fetal fibronectin. When progesterone is rate was significantly lower among women receiv- used, it is important to restrict its use to only women ing progesterone than among those receiving place- with a documented history of a previous sponta- bo (2.7% versus 18.6%) (2). The results of this study neous birth at less than 37 weeks of gestation and the NICHD trial support the hypothesis that because unresolved issues remain, such as optimal progesterone supplementation reduces preterm birth route of drug delivery and long-term safety of the in a select very high-risk group of women.
Despite the apparent benefits of progesterone in a high-risk population, the ideal progesterone for-mulation is unknown. The 17P used in the NICHD References
trial was specially formulated for research and is not 1. Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai currently commercially available on a wide scale.
B, Moawad AH, et al. Prevention of recurrent pretermdelivery by 17 alpha-hydroxyprogesterone caproate. N Progesterone has been studied only as a prophylac- tic measure in asymptomatic women, not as a 2. da Fonseca EB, Bittar RE, Carvalho MH, Zugaib M.
tocolytic agent. Whether vaginal progesterone is Prophylactic administration of progesterone by vaginal equally efficacious remains to be proved in a larger suppository to reduce the incidence of spontaneouspreterm birth in women at increased risk: a randomized population. The American College of Obstetricians placebo-controlled double-blind study. Am J Obstet and Gynecologists Committee on Obstetric Practice believes that further studies are needed to evaluate

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