Effectiveness of Metformin in Recurrent Miscarriage in a Woman With Hyperinsulinaemia
Overview[ - collapse ][ - ]
| Purpose | 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. |
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| Condition | Abortion, Habitual |
| Intervention | Drug: Metformin |
| Phase | Phase 4 |
| Sponsor | Woman's Health University Hospital, Egypt |
| Responsible Party | Woman's Health University Hospital, Egypt |
| ClinicalTrials.gov Identifier | NCT01718340 |
| First Received | August 18, 2012 |
| Last Updated | October 30, 2012 |
| Last verified | October 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 18, 2012 |
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| Last Updated Date | October 30, 2012 |
| Start Date | June 2010 |
| Estimated Primary Completion Date | August 2012 |
| Current Primary Outcome Measures | 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, |
| Current Secondary Outcome Measures | 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. |
Descriptive Information[ + expand ][ + ]
| Brief Title | Effectiveness of Metformin in Recurrent Miscarriage in a Woman With Hyperinsulinaemia |
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| Official Title | Phase 4 Study of Effectiveness of Metformin in Patients With Unexplained Recurrent Miscarriages |
| 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. |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Abortion, Habitual |
| Intervention | Drug: Metformin metformin tablet 500mg three time per day Other Names:
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| Study Arm (s) | 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 |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
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| Estimated Enrollment | 396 |
| Estimated Completion Date | August 2012 |
| Estimated Primary Completion Date | August 2012 |
| 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). |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | Egypt |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01718340 |
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| Other Study ID Numbers | MetRPL |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Woman's Health University Hospital, Egypt |
| Study Sponsor | Woman's Health University Hospital, Egypt |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Alaa M Ismail, M D Faculty of medicine,Assiut university,Egypt |
| Verification Date | October 2012 |
Locations[ + expand ][ + ]
| Women's Health Hospital | Assiut, Egypt |
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