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Preconceptional Progesterone Treatment in Women With Unexplained Recurrent Miscarriage, a Randomized Double-blind Controlled Trial

Information source: Woman's Health University Hospital, Egypt
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Abortion, Habitual

Intervention: Progesterone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Woman's Health University Hospital, Egypt

Official(s) and/or principal investigator(s):
Alaa M Ismail, M D, Principal Investigator, Affiliation: Faculity of medicine,Assiut university

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, ).

Clinical Details

Official title: Phase 4 Preconceptional Progesterone in Patients With Recurrent Unexplained Miscarriages

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Ongoing pregnancy after 10 weeks (range 11-20 weeks)

Secondary outcome: miscarriage rate

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.

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

Inclusion Criteria: 1. Women with unexplained recurrent miscarriages (2 or more consecutive first trimester miscarriages). 2. 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). 3. Spontaneous conception (as confirmed by urinary pregnancy tests). 4. Willing and able to give informed consent. Exclusion Criteria: 1. Age above forty years old. 2. Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies [IgG or IgM]); other recognised thrombophilic conditions (testing according to usual clinic practice). 3. Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy). 4. Fibroids distorting uterine cavity. 5. Abnormal parental karyotype. 6. Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e. g., diabetes, thyroid disease and systemic lupus erythematosus (SLE).

Locations and Contacts

Women's Health Hospital, Assiut, Egypt
Additional Information

Starting date: September 2012
Last updated: August 4, 2014

Page last updated: August 23, 2015

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