NCT01718340

Effectiveness of Metformin in Recurrent Miscarriage in a Woman With Hyperinsulinaemia

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Woman's Health University Hospital, Egypt · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Abortion, Habitual

Interventions

Type	Name	Description
DRUG	Metformin	metformin tablet 500mg three time per day

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2012-10-31
• Last updated: 2021-01-08

Locations

1 site across 1 country: Egypt