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Meta-Analysis
. 2019 Nov 20;2019(11):CD003511.
doi: 10.1002/14651858.CD003511.pub5.

Progestogen for preventing miscarriage in women with recurrent miscarriage of unclear etiology

David M Haas  1 , Taylor J Hathaway  1 , Patrick S Ramsey  2
Affiliations
Meta-Analysis

Progestogen for preventing miscarriage in women with recurrent miscarriage of unclear etiology

David M Haas et al. Cochrane Database Syst Rev. .

Update in

Abstract

Background: Progesterone, a female sex hormone, is known to induce secretory changes in the lining of the uterus essential for successful implantation of a fertilized egg. It has been suggested that a causative factor in many cases of miscarriage may be inadequate secretion of progesterone. Therefore, clinicians use progestogens (drugs that interact with the progesterone receptors), beginning in the first trimester of pregnancy, in an attempt to prevent spontaneous miscarriage. This is an update of a review, last published in 2013. Since publication of the 2018 update of this review, we have been advised that the Ismail 2017 study is currently the subject of an investigation by the Journal of Maternal-Fetal & Neonatal Medicine. We have now moved this study from 'included studies' to 'Characteristics of studies awaiting classification' until the outcome of the investigation is known.

Objectives: To assess the efficacy and safety of progestogens as a preventative therapy against recurrent miscarriage.

Search methods: For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (6 July 2017) and reference lists from relevant articles, attempting to contact trial authors where necessary, and contacted experts in the field for unpublished works.

Selection criteria: Randomized or quasi-randomized controlled trials comparing progestogens with placebo or no treatment given in an effort to prevent miscarriage.

Data collection and analysis: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. Two reviewers assessed the quality of the evidence using the GRADE approach.

Main results: Twelve trials (1,856 women) met the inclusion criteria. Eight of the included trials compared treatment with placebo and the remaining four trials compared progestogen administration with no treatment. The trials were a mix of multicenter and single-center trials, conducted in India, Jordan, UK and USA. In five trials women had had three or more consecutive miscarriages and in seven trials women had suffered two or more consecutive miscarriages. Routes, dosage and duration of progestogen treatment varied across the trials. The majority of trials were at low risk of bias for most domains. Ten trials (1684 women) contributed data to the analyses. The meta-analysis of all women, suggests that there may be a reduction in the number of miscarriages for women given progestogen supplementation compared to placebo/controls (average risk ratio (RR) 0.73, 95% confidence interval (CI) 0.54 to 1.00, 10 trials, 1684 women, moderate-quality evidence). A subgroup analysis comparing placebo-controlled versus non-placebo-controlled trials, trials of women with three or more prior miscarriages compared to women with two or more miscarriages and different routes of administration showed no clear differences between subgroups for miscarriage. None of the trials reported on any secondary maternal outcomes, including severity of morning sickness, thromboembolic events, depression, admission to a special care unit, or subsequent fertility. There was probably a slight benefit for women receiving progestogen seen in the outcome of live birth rate (RR 1.07, 95% CI 1.00 to 1.13, 6 trials, 1411 women, moderate-quality evidence). We are uncertain about the effect on the rate of preterm birth because the evidence is very low-quality (RR 1.13, 95% CI 0.53 to 2.41, 4 trials, 256 women, very low-quality evidence). No clear differences were seen for women receiving progestogen for the other secondary outcomes including neonatal death, fetal genital abnormalities or stillbirth. There may be little or no difference in the rate of low birthweight and trials did not report on the secondary child outcomes of teratogenic effects or admission to a special care unit.

Authors' conclusions: For women with unexplained recurrent miscarriages, supplementation with progestogen therapy may reduce the rate of miscarriage in subsequent pregnancies.

PubMed Disclaimer

Conflict of interest statement

David M Haas: none known

Taylor J Hathaway: none known

Patrick S Ramsey: I serve as an officer in Section 5 of District XI of the American College and Congress of Obstetricians and Gynecologists. I received compensation for this general work with ACOG but have not engaged in any specific work relevant to the topic of this review. I also serve on the Data Safety Monitoring Board for the KV Pharmaceutical RCT designed to evaluate the efficacy of 17‐hydroxyprogesterone caproate to prevent preterm birth. I received compensation for service as the DSMB chair from an independent data management organization and not from the pharmaceutical company.

Figures

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Funnel plot of comparison 1. Progestogen versus placebo/no treatment, outcome 1.1 Miscarriage (all trials)
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Study flow diagram
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'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
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4
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study
See this image and copyright information in PMC

Update of

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MeSH terms

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