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Progestogens for Prevention of Preterm Birth

Comparative Effectiveness Reviews, No. 74

Investigators: , DrPH, NP, CNM, , MD, , PhD, , PhD, , MLIS, MPH, , PhD, , MPH, and , MD, PhD.

Vanderbilt Evidence-based Practice Center
Rockville (MD): Agency for Healthcare Research and Quality (US); .
Report No.: 12-EHC105-EF

Structured Abstract

Objectives:

The Vanderbilt Evidence-based Practice Center systematically reviewed evidence addressing administration of progestogens to prevent preterm birth.

Data Sources:

We searched MEDLINE® and Embase for articles published in English from January 1966 to October 2010. A focused update was added through October 2011.

Review Methods:

We excluded publications that did not address a Key Question, were not research, or had fewer than 20 participants. We included 70 publications: 8 were good quality; 43, fair; and 19, poor. Sixteen randomized controlled trials (RCTs) contributed data for Bayesian meta-analysis. The update netted eight additional RCTs.

Results:

Among women with prior preterm birth and a singleton pregnancy (four RCTs), progestogen treatment decreased the risk of preterm birth (Odds Ratio [OR]=0.66, 95% Bayesian credible interval [BCI]: 0.53, 0.82), corresponding to an absolute reduction in risk of preterm birth between 0 and 26 percent across studies. In this population, progestogens also reduced neonatal death (OR=0.52, 95% BCI: 0.25, 0.96). Two trials of progestogen administration among women with short cervical length, one identified in the main portion of the review and the latter in the focused update, report reduction of risk of preterm birth with an absolute reduction in risk of 8.8 and 15.2 percent. Evidence of benefit for other maternal, fetal, or neonatal health outcomes is inconsistent or absent. In multiple gestations, progestogen treatment does not prevent prematurity (preterm birth OR=1.18, 95% BCI: 0.79, 1.39), enhance birthweight, or improve other outcomes.

No maternal factors, such as number or severity of prior preterm births, have been definitively shown to modify effects of progestogen treatment. Similarly, direct comparisons have not been made between routes of administration or doses in RCTs. Across RCTs (n=15), no formulation was effective at reducing risk for neonatal mortality, but all were effective at reducing the risk of preterm birth (meta-estimates: OR17OHP1 =0.75, 95% BCI: 0.60, 0.90 OROral=0.56, 95% BCI: 0.36, 0.79; ORVaginal=0.76, 95% BCI: 0.57, 0.98). Evidence is insufficient to determine whether time of initiation and adherence to treatment influence outcomes. Factors associated with adherence to treatment have not been systematically studied.

Potential adverse effects (harms) were not uniformly assessed in this literature. Study participants withdrew from treatment and placebo groups in similar small proportions. Long-term maternal and infant effects have not been well studied. No data were available from large registries for surveillance of rare outcomes such as fetal death. Publications about provider- and system-level factors confirm wide variability in use of progestogens, use in populations that lack clear evidence of benefit, and desire for data about longer term benefits and risk of harms.

Conclusions:

Progestogens prevent preterm birth when used in singleton pregnancy in which the mother has had a prior spontaneous preterm birth or in which cervical length is short. The strength of the evidence supporting its use for these indications is moderate and low, respectively. In contrast, moderate strength of evidence suggests lack of effectiveness for multiple gestations. Evidence is insufficient for all other uses. Across indications, data are sparse to evaluate influence on near-term outcomes such as neonatal mortality and morbidities. Evidence is insufficient for understanding whether intervention has the ultimately desired outcome of preventing morbidity and promoting normal childhood development.

Contents

Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services2, Contract No. 290-2007-10065-I, Prepared by: Vanderbilt Evidence-based Practice Center, Nashville, TN

Suggested citation:

Likis FE, Andrews JC, Woodworth AL, Velez Edwards DR, Jerome RN, Fonnesbeck CJ, McKoy JN, Hartmann KE. Progestogens for Prevention of Preterm Birth. Comparative Effectiveness Review No. 74. (Prepared by the Vanderbilt Evidence-based Practice Center under Contract No. 290-2007-10065-I). AHRQ Publication No. 12-EHC105-EF. Rockville, MD: Agency for Healthcare Research and Quality. September 2012. www.effectivehealthcare.ahrq.gov/reports/final.cfm.

This report is based on research conducted by the Vanderbilt University Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2007-10065-I). The findings and conclusions in this document are those of the authors, who are responsible for its content, and do not necessarily represent the views of AHRQ. No statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.

The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.

This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.

None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.

1

17 alpha-hydroxyprogesterone caproate

2

540 Gaither Road, Rockville, MD 20850; www‚Äč.ahrq.gov

Bookshelf ID: NBK109368PMID: 23101048

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