Pr-conceptional Progesterone for Unexplained Recurrent Miscarriage
|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 ]
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|