Mutation Clinical Trial
— C677TOfficial title:
Comparison of Two Preventive Treatments for Patients With Recurrent Miscarriages Carrying a C677T Methylenetetrahydrofolate Reductase Mutation: 5-year Experience
Verified date | September 2018 |
Source | Centre Hospitalier Universitaire, Amiens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To investigate the effect of anticoagulant treatment on pregnancy outcomes in patients with previous recurrent miscarriages (RM) who carry a methylenetetrahydrofolate reductase (MTHFR) gene mutation. In this longitudinal retrospective study, patients with RM were treated during pregnancy with either: (i) 100 mg/day aspirin and 5 mg/day folic acid (group 1); or the same protocol plus 0.4 mg/day enoxaparin (group 2). An age-matched group of triparous women without RM or thrombophilia was used as the control group (group 3).
Status | Completed |
Enrollment | 363 |
Est. completion date | September 28, 2016 |
Est. primary completion date | September 28, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - patients with three or more consecutive first-trimester miscarriage - Three or more consecutive first-trimester miscatrriages - C677T MTHFR gene mutation Exclusion Criteria: - Patients with the A1298C polymorphism |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire, Amiens |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | number of miscarriages | The objective of this study was to evaluate the effect of three components: aspirin, alpha blockers and folic acid in women with miscarriages consecutive first-trimester mutation of the MTHFR C677T gene versus the effet of a combination of aspirin and folic acid in patients with three or more consecutive first-trimester miscarriages who were carrying the C677T MTHFR gene mutation | 2years |
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