Pr-conceptional Progesterone for Unexplained Recurrent Miscarriage

Study Overview
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Brief Summary
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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
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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.

Conditions
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Abortion, Habitual

Intervention / Treatment
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* Drug: Progesterone
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Progesterone group<br>progesterone (400 mg pessary, once daily) | Drug: Progesterone<br> <br> |
| Placebo Comparator: Placebo group<br>Placebo (pessary, once daily) | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients continued the pregnancy beyond 20 weeks gestation. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of miscarriages |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent miscarriages, progesterone