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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Woman's Health University Hospital, Egypt
Sponsor:
Information provided by (Responsible Party):
alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier:
NCT01718340
First received: August 18, 2012
Last updated: May 25, 2014
Last verified: May 2014

August 18, 2012
May 25, 2014
June 2012
June 2014   (final data collection date for primary outcome 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 [ Time Frame: 2 ys ] [ Designated as safety issue: Yes ]
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,
Same as current
Complete list of historical versions of study NCT01718340 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
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.
Same as current
Not Provided
Not Provided
 
Effectiveness of Metformin in Recurrent Miscarriage in a Woman With Hyperinsulinaemia
Phase 4 Study of Effectiveness of Metformin in Patients With Unexplained Recurrent Miscarriages

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Abortion, Habitual
Drug: Metformin
metformin tablet 500mg three time per day
Other Names:
  • glucophage
  • cidophage
  • amophage
Experimental: Metformin
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
Intervention: Drug: Metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
396
June 2014
June 2014   (final data collection date for primary outcome measure)

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).
Female
18 Years to 40 Years
Yes
Contact: Alaa M Ismail, M D +201000459514 dr.alaa_ismail@yahoo.com
Contact: Hassan S Kamel, M D + hkamehkamel@yahoo.com
Egypt
 
NCT01718340
MetRPL
Yes
alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt
Woman's Health University Hospital, Egypt
Not Provided
Principal Investigator: Alaa M Ismail, M D Faculty of medicine,Assiut university,Egypt
Woman's Health University Hospital, Egypt
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP