Pr-conceptional Progesterone for Unexplained Recurrent Miscarriage
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
- Number of patients continued the pregnancy beyond 20 weeks gestation. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Number of miscarriages [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Number of Live Birth [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Number of preterm delivery [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2012|
|Study Completion Date:||November 2015|
|Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Progesterone group
progesterone (400 mg pessary, once daily)
Placebo Comparator: Placebo group
Placebo (pessary, once daily)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01670929
|Women's Health Hospital|
|Principal Investigator:||Alaa M Ismail, M D||Faculity of medicine,Assiut university|