The Role of Metformin for Prevention of First Trimesteric Miscarriage in Women With Polycystic Ovary Syndrome: A Randomized Controlled Trial
Abstract
Background: This study aimed to evaluate the effect of metformin on early pregnancy loss (EPL) in pregnant women with olycystic ovary syndrome (PCOS).Patients and Methods: A randomized clinical trial (Clinicaltrials.gov NCT 02498522) was conducted in Ain-Shams Maternity Hospital in the period between August 2018 and July 2019. One hundred and sixty six women previously diagnosed with PCOS and got pregnant with induction of ovulation in concomitance with Metformin were randomized either Metformin 500 mg orally every 8 hours until the end of the 1st trimester or not receiving Metformin. The primary outcome is to observe any significant decline in the incidence of EPL in PCOS patients after administration of Metformin through out 1st trimester.Results: There was a significant reduction in miscarriage rate after administration of Metformin during 1st trimester. Introduction of Metformin helped pregnancy loss rate to drop to 10.8% while the rate in the group discontinued Metformin was 42.2% (p < 0.05). The side effects rate as nausea, vomiting, gastric irritation and flatulence was significantly higher in the Metformin group.Conclusion: The use of Metformin in patients with PCOS during 1st trimester reduces the incidence of early pregnancy loss (EPL).
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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