Estimated Effect of 17 Alpha-Hydroxyprogesterone Caproate on Preterm Birth in the United States

Department of Obstetrics & Gynecology & Women's Health, Albert Einstein College of Medicine, New York, New York, United States
Obstetrics and Gynecology (Impact Factor: 5.18). 03/2005; 105(2):267-72. DOI: 10.1097/01.AOG.0000150560.24297.4f
Source: PubMed


A multicenter, randomized placebo-controlled trial among women with singleton pregnancies and a history of spontaneous preterm birth found that weekly injections of 17 alpha-hydroxyprogesterone caproate (17P), initiated between 16 and 20 weeks of gestation, reduced preterm birth by 33%. The current study estimated both preterm birth recurrence and the potential reduction in the national preterm birth rate.
Using 2002 national birth certificate data, augmented by vital statistics from 2 states, we estimated the number of singleton births delivered to women eligible for 17P through both a history of spontaneous preterm birth and prenatal care onset within the first 4 months of pregnancy. The number and rate of recurrent spontaneous preterm births were estimated. To predict effect, the reported 33% reduction in spontaneous preterm birth attributed to 17P therapy was applied to these estimates.
In 2002, approximately 30,000 recurrent preterm births occurred to women eligible for 17P, having had a recurrent preterm birth rate of 22.5%. If 17P therapy were delivered to these women, nearly 10,000 spontaneous preterm births would have been prevented, thereby reducing the overall United States preterm birth rate by approximately 2%, from 12.1% to 11.8% (P < .001), with higher reductions in targeted groups of eligible pregnant women.
Use of 17P could reduce preterm birth among eligible women, but would likely have a modest effect on the national preterm birth rate. Additional research is urgently needed to identify other populations who might benefit from 17P, evaluate new methods for early detection of women at risk, and develop additional prevention strategies.

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Available from: Joann Petrini, Dec 10, 2014
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    • "According to the available data, 17OH-PC prevents approximately one third of recurrent preterm births. While this is encouraging from an individual standpoint, the public health impact is somewhat limited given that only 15% of preterm deliveries occur in women with a prior preterm birth.11 It has been estimated that if all pregnant women with a history of spontaneous preterm delivery could receive prophylactic progesterone supplementation, the overall preterm delivery rate in the US would be reduced by approximately 2%.11 "
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    ABSTRACT: Prevention of preterm delivery is a major desiderate in contemporary obstetrics and a societal necessity. The means to achieve this goal remain elusive. Progesterone has been used in an attempt to prevent preterm delivery since the 1970s, but the evidence initially accumulated was fraught by mixed results and was based on mostly underpowered studies with variable eligibility criteria, including history of spontaneous abortion as an indication for treatment. More recent randomized controlled clinical trials restimulated the interest in progesterone supplementation, suggesting that progesterone may favorably influence the rate of preterm delivery. Preterm delivery is a complex disorder and consequently it is unlikely that one generalized prevention strategy will be effective in all patients. Further, an additional impediment in accepting progesterone as the "magic bullet" in the prevention of preterm delivery is that its mechanism of action is not fully understood and the optimal formulations, route of administration, and dose have yet to be established. We have concerned ourselves in this review with the most recent status of 17 alpha-hydroxyprogesterone caproate (17OH-PC) supplementation for prevention of preterm delivery. Our intention is to emphasize the efficacy, safety, and patient acceptability of this intervention, based on a comprehensive and unbiased review of the available literature. Currently there are insufficient data to suggest that 17OH-PC is superior or inferior to natural progesterone. Based on available evidence, we suggest a differential approach giving preferential consideration to either 17OH-PC or other progestins based on obstetric history and cervical surveillance. Progestin therapy for risk factors other than a history of preterm birth and/or a short cervix in the current pregnancy is not currently supported by the published evidence. The experience to date with 17OH-PC indicates that there are population subgroups that may be harmed by administration of 17OH-PC. Therefore, extending the use of 17OH-PC to unstudied populations or for indications that are not evidence-based is inadvisable outside of a research protocol.
    Preview · Article · Jul 2013 · Patient Preference and Adherence
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    • "For 8.2% of women with a previous preterm birth, subsequent infants will be born at a similar gestational age[12]. Other authors have estimated the rate of recurrent preterm birth to be 22.5%[13], which represents a two and a half fold increase in the risk of preterm birth, when compared with women who have not had a previous spontaneous preterm birth[14]. "
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