Pr-conceptional Progesterone for Unexplained Recurrent Miscarriage
Overview
- Phase
- Phase 4
- Intervention
- Progesterone
- Conditions
- Abortion, Habitual
- Sponsor
- Woman's Health University Hospital, Egypt
- Enrollment
- 700
- Locations
- 1
- Primary Endpoint
- Number of patients continued the pregnancy beyond 20 weeks gestation.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
In women with unexplained recurrent miscarriages, progesterone (400 mg pessaries, twice daily), started soon as possible at luteal phase and after a positive pregnancy test and continued to 28 weeks of gestation, compared to placebo, ).
Detailed Description
Progesterone improves secondary outcomes such as gestation at delivery, on-going pregnancy at 12 weeks, survival at 28 days of neonatal life. . Progesterone, compared to placebo, does not incur substantial adverse effects to the mother or the neonate. Explore differential or subgroup effects of progesterone in prognostic subgroups. . Perform an economic evaluation for cost-effectiveness.
Investigators
alaa eldeen mahmoud ismail
M D
Woman's Health University Hospital, Egypt
Eligibility Criteria
Inclusion Criteria
- •Women with unexplained recurrent miscarriages (2 or more consecutive first trimester miscarriages).
- •Age 18-39 years at randomisation (likelihood of miscarriages due to chromosomal aberrations is higher in older women; such miscarriages are unlikely to be prevented by progesterone therapy).
- •Spontaneous conception (as confirmed by urinary pregnancy tests).
- •Willing and able to give informed consent.
Exclusion Criteria
- •Age less than twenty or 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).
Arms & Interventions
Progesterone group
progesterone (400 mg pessary, once daily)
Intervention: Progesterone
Placebo group
Placebo (pessary, once daily)
Intervention: Placebo
Outcomes
Primary Outcomes
Number of patients continued the pregnancy beyond 20 weeks gestation.
Time Frame: 2 years
Secondary Outcomes
- Number of miscarriages(2 years)