Clinical Trial: Pr-conceptional Progesterone for Unexplained Recurrent Miscarriage

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

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, ).

Detailed Summary:

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.


Sponsor: Woman's Health University Hospital, Egypt

Current Primary Outcome: Number of patients continued the pregnancy beyond 20 weeks gestation. [ Time Frame: 2 years ]

Original Primary Outcome: Live births beyond 32 weeks [ Time Frame: 2 years ]

progesterone (400 mg pessaries, twice daily), started soon as possible at luteal phase and after a positive pregnancy test and continued to 32 weeks of gestation.


Current Secondary Outcome: Number of miscarriages [ Time Frame: 2 years ]

Original Secondary Outcome: Gestation at delivery and fetal weight AND Congenital abnormalities with specific examination for genital anomalies [ Time Frame: 2 years ]

Gestation at delivery and fetal weight Doppler changes in both groups. Survival at 32 days of neonatal life


Information By: Woman's Health University Hospital, Egypt

Dates:
Date Received: August 17, 2012
Date Started: September 2012
Date Completion:
Last Updated: April 3, 2016
Last Verified: April 2016