Effectiveness of Metformin in Recurrent Miscarriage in a Woman With Hyperinsulinaemia

NCT01718340 | Withdrawn Phase 4 DMC

• 1 other identifier: MetRPL
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Abortion, Habitual

Keywords

PCOS; Hyper insulinaemia; metformin; recurrent abortion

Outcome Measures

Primary Outcomes (1)

• The primary outcome is to evaluate the clinical pregnancy rate and the effectiveness of Metformin in the reduction of EPL in women with PCOS

  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,

  2 ys

Secondary Outcomes (1)

• 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

  2 ys

Study Arms (1)

Metformin

EXPERIMENTAL

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

Drug: Metformin

Interventions

Metformin DRUG

metformin tablet 500mg three time per day

Also known as: glucophage, cidophage, amophage

Metformin

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Woman's Health University Hospital, Egypt: lead

Study Sites (1)

Women's Health Hospital

Asyut, Egypt

Location

MeSH Terms

Conditions

Abortion, Habitual

Interventions

Metformin

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Alaa M Ismail, M D

  Faculty of medicine,Assiut university,Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M D

Study Record Dates

• First Submitted: August 18, 2012
• First Posted: October 31, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 8, 2021

Record last verified: 2021-01

Locations

EG (1)