Clinical trial NCT01718340: Effectiveness of Metformin in Recurrent Miscarriage in a Woman With Hyperinsulinaemia
Official title: Phase 4 Study of Effectiveness of Metformin in Patients With Unexplained Recurrent Miscarriages
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Abortion, Habitual
Keywords: PCOS
Hyper insulinaemia
metformin
recurrent abortion
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
First posted: 2012-10-31
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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).

Primary outcomes:
measure: The primary outcome is to evaluate the clinical pregnancy rate and the effectiveness of Metformin in the reduction of EPL in women with PCOS
timeFrame: 2 ys
Secondary outcomes:
measure: 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
timeFrame: 2 ys
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women's Health Hospital
Study officials:
affiliation: Faculty of medicine,Assiut university,Egypt
name: Alaa M Ismail, M D
role: PRINCIPAL_INVESTIGATOR
References: