Clinical Trial: Effectiveness of Metformin in Recurrent Miscarriage in a Woman With Hyperinsulinaemia

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Phase 4 Study of Effectiveness of Metformin in Patients With Unexplained Recurrent Miscarriages

Brief Summary:

The prevalence of insulin resistance is increased in women with recurrent miscarriage compared with matched fertile controls,Insulin resistance (IR) in this syndrome is not only implicated toward early pregnancy loss (EPL) but also pathognomic for various obstetrical complications during pregnancy.An elevated free androgen index appears to be a prognostic factor for a subsequent miscarriage in women with recurrent miscarriage.

There is insufficient evidence to evaluate the effect of metformin supplementation in pregnancy to prevent a miscarriage in women with recurrent miscarriage.


Detailed Summary: The patients with PCO and hyper insulinemia will be subdivided into two groups, one group will continue metformin 500 mg three times per day from the start of induction of ovulation till the end of pregnancy, the other group will stop the drug once pregnancy test become positive. Pregnancy follow up including the early and second trimester pregnancy loss, Secondary outcomes like gestational diabetes, pregnancy-induced hypertension and intrauterine growth restriction were also analyzed at the end of the study.
Sponsor: Woman's Health University Hospital, Egypt

Current Primary Outcome: The primary outcome is to evaluate the clinical pregnancy rate and the effectiveness of Metformin in the reduction of EPL in women with PCOS [ Time Frame: 2 ys ]

The patients with PCO and hyper insulinemia will be subdivided into two groups, one group will continue metformin 500 mg three times per day from the start of induction of ovulation till the end of pregnancy,


Original Primary Outcome: Same as current

Current Secondary Outcome: Secondary outcomes like gestational diabetes, pregnancy-induced hypertension and intrauterine growth restriction were also analyzed at the end of the study and any fetal malformation [ Time Frame: 2 ys ]

The patients with PCO and hyper insulinemia will be subdivided into two groups, one group will continue metformin 500 mg three times per day from the start of induction of ovulation till the end of pregnancy, the other group will stop the drug once pregnancy test become positive. Pregnancy follow up including the early and second trimester pregnancy loss, Secondary outcomes like gestational diabetes, pregnancy-induced hypertension and intrauterine growth restriction were also analyzed at the end of the study.


Original Secondary Outcome: Same as current

Information By: Woman's Health University Hospital, Egypt

Dates:
Date Received: August 18, 2012
Date Started: June 2012
Date Completion: June 2014
Last Updated: May 25, 2014
Last Verified: May 2014