Pr-conceptional Progesterone for Unexplained Recurrent Miscarriage
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|ClinicalTrials.gov Identifier: NCT01670929|
Recruitment Status : Completed
First Posted : August 22, 2012
Last Update Posted : April 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Abortion, Habitual||Drug: Progesterone Other: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||700 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||November 2015|
Active Comparator: Progesterone group
progesterone (400 mg pessary, once daily)
Placebo Comparator: Placebo group
Placebo (pessary, once daily)
- Number of patients continued the pregnancy beyond 20 weeks gestation. [ Time Frame: 2 years ]
- Number of miscarriages [ Time Frame: 2 years ]
- Number of Live Birth [ Time Frame: 2 years ]
- Number of preterm delivery [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01670929
|Women's Health Hospital|
|Principal Investigator:||Alaa M Ismail, M D||Faculity of medicine,Assiut university|