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Progestogen for preventing miscarriage.

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, progestogens have been used, beginning in the first trimester of pregnancy, in an attempt to prevent spontaneous miscarriage.

OBJECTIVES

To determine the efficacy and safety of progestogens as a preventative therapy against miscarriage.

SEARCH METHODS

We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 August 2013), reference lists from relevant articles, attempting to contact authors where necessary, and contacted experts in the field for unpublished works.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 assessed trial quality and extracted data.

MAIN RESULTS

Fourteen trials (2158 women) are included. The meta-analysis of all women, regardless of gravidity and number of previous miscarriages, showed no statistically significant difference in the risk of miscarriage between progestogen and placebo or no treatment groups (Peto odds ratio (Peto OR) 0.99; 95% confidence interval (CI) 0.78 to 1.24) and no statistically significant difference in the incidence of adverse effect in either mother or baby.A subgroup analysis of placebo controlled trials did not find a difference in the rate of miscarriage with the use of progestogen (10 trials, 1028 women; Peto OR 1.15; 95% CI 0.88 to 1.50).In a subgroup analysis of four trials involving women who had recurrent miscarriages (three or more consecutive miscarriages; four trials, 225 women), progestogen treatment showed a statistically significant decrease in miscarriage rate compared to placebo or no treatment (Peto OR 0.39; 95% CI 0.21 to 0.72). However, these four trials were of poorer methodological quality. No statistically significant differences were found between the route of administration of progestogen (oral, intramuscular, vaginal) versus placebo or no treatment. No significant differences in the rates of preterm birth, neonatal death, or fetal genital anomalies/virilization were found between progestogen therapy versus placebo/control.

AUTHORS' CONCLUSIONS

There is no evidence to support the routine use of progestogen to prevent miscarriage in early to mid-pregnancy. However, there seems to be evidence of benefit in women with a history of recurrent miscarriage. Treatment for these women may be warranted given the reduced rates of miscarriage in the treatment group and the finding of no statistically significant difference between treatment and control groups in rates of adverse effects suffered by either mother or baby in the available evidence. Larger trials are currently underway to inform treatment for this group of women.

Authors+Show Affiliations

Department of Obstetrics and Gynecology, Indiana University School of Medicine, 1001 West 10th Street, F-5, Indianapolis, Indiana, USA, IN 46202.No affiliation info available

Pub Type(s)

Journal Article
Meta-Analysis
Review
Systematic Review

Language

eng

PubMed ID

24173668

Citation

Haas, David M., and Patrick S. Ramsey. "Progestogen for Preventing Miscarriage." The Cochrane Database of Systematic Reviews, 2013, p. CD003511.
Haas DM, Ramsey PS. Progestogen for preventing miscarriage. Cochrane Database Syst Rev. 2013.
Haas, D. M., & Ramsey, P. S. (2013). Progestogen for preventing miscarriage. The Cochrane Database of Systematic Reviews, (10), CD003511. https://doi.org/10.1002/14651858.CD003511.pub3
Haas DM, Ramsey PS. Progestogen for Preventing Miscarriage. Cochrane Database Syst Rev. 2013 Oct 31;(10)CD003511. PubMed PMID: 24173668.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Progestogen for preventing miscarriage. AU - Haas,David M, AU - Ramsey,Patrick S, Y1 - 2013/10/31/ PY - 2013/11/1/entrez PY - 2013/11/1/pubmed PY - 2014/4/29/medline SP - CD003511 EP - CD003511 JF - The Cochrane database of systematic reviews JO - Cochrane Database Syst Rev IS - 10 N2 - 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, progestogens have been used, beginning in the first trimester of pregnancy, in an attempt to prevent spontaneous miscarriage. OBJECTIVES: To determine the efficacy and safety of progestogens as a preventative therapy against miscarriage. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 August 2013), reference lists from relevant articles, attempting to contact 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 assessed trial quality and extracted data. MAIN RESULTS: Fourteen trials (2158 women) are included. The meta-analysis of all women, regardless of gravidity and number of previous miscarriages, showed no statistically significant difference in the risk of miscarriage between progestogen and placebo or no treatment groups (Peto odds ratio (Peto OR) 0.99; 95% confidence interval (CI) 0.78 to 1.24) and no statistically significant difference in the incidence of adverse effect in either mother or baby.A subgroup analysis of placebo controlled trials did not find a difference in the rate of miscarriage with the use of progestogen (10 trials, 1028 women; Peto OR 1.15; 95% CI 0.88 to 1.50).In a subgroup analysis of four trials involving women who had recurrent miscarriages (three or more consecutive miscarriages; four trials, 225 women), progestogen treatment showed a statistically significant decrease in miscarriage rate compared to placebo or no treatment (Peto OR 0.39; 95% CI 0.21 to 0.72). However, these four trials were of poorer methodological quality. No statistically significant differences were found between the route of administration of progestogen (oral, intramuscular, vaginal) versus placebo or no treatment. No significant differences in the rates of preterm birth, neonatal death, or fetal genital anomalies/virilization were found between progestogen therapy versus placebo/control. AUTHORS' CONCLUSIONS: There is no evidence to support the routine use of progestogen to prevent miscarriage in early to mid-pregnancy. However, there seems to be evidence of benefit in women with a history of recurrent miscarriage. Treatment for these women may be warranted given the reduced rates of miscarriage in the treatment group and the finding of no statistically significant difference between treatment and control groups in rates of adverse effects suffered by either mother or baby in the available evidence. Larger trials are currently underway to inform treatment for this group of women. SN - 1469-493X UR - https://www.unboundmedicine.com/medline/citation/24173668/Progestogen_for_preventing_miscarriage_ L2 - https://doi.org/10.1002/14651858.CD003511.pub3 DB - PRIME DP - Unbound Medicine ER -