Pr-conceptional Progesterone for Unexplained Recurrent Miscarriage
1 other identifier
interventional
700
1 country
1
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, ).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2012
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2012
CompletedFirst Posted
Study publicly available on registry
August 22, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedApril 5, 2016
April 1, 2016
2.7 years
August 17, 2012
April 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients continued the pregnancy beyond 20 weeks gestation.
2 years
Secondary Outcomes (1)
Number of miscarriages
2 years
Other Outcomes (2)
Number of Live Birth
2 years
Number of preterm delivery
2 years
Study Arms (2)
Progesterone group
ACTIVE COMPARATORprogesterone (400 mg pessary, once daily)
Placebo group
PLACEBO COMPARATORPlacebo (pessary, once daily)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Women's Health Hospital
Asyut, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alaa M Ismail, M D
Faculity of medicine,Assiut university
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M D
Study Record Dates
First Submitted
August 17, 2012
First Posted
August 22, 2012
Study Start
September 1, 2012
Primary Completion
May 1, 2015
Study Completion
November 1, 2015
Last Updated
April 5, 2016
Record last verified: 2016-04