Effectiveness of Metformin in Recurrent Miscarriage in a Woman With Hyperinsulinaemia (MetRPL)

Woman's Health University Hospital, Egypt

Status and phase

Withdrawn

Phase 4

Conditions

Abortion, Habitual

Treatments

Drug: Metformin

Study type

Interventional

Funder types

Other

Identifiers

NCT01718340

MetRPL

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

women who are diagnosed to have PCOS and/or haven hyper insulinaemia and have a previous history of recurrent miscarriages.

Exclusion criteria

Any patients with PCOS or hyper insulinaemia previously treated by any forms of insulin sensitizers.

Age above forty years old .

Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies [IgG or IgM]); other recognised thrombophilic conditions (testing according to usual clinic practice).
Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
Fibroids distorting uterine cavity .
Abnormal parental karyotype .
Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE).