An interventional study of micronized progesterone 200 mg (Utrogestan) and placebo in Antepartum Bleeding and Preterm Birth, sponsored by HaEmek Medical Center, Israel. Terminated at 3 sites in Israel. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-06.
Sponsored by HaEmek Medical Center, Israel · Not applicable, Interventional, and Prevention
Working hypothesis and aims:
To investigate whether progesterone treatment affects the incidence of preterm labor compared to placebo, among women with 2nd trimester bleeding.
The participants will be allocated through randomization to a study or control group. Women in the study group will receive micronized progesterone 200 mg (Utrogestan, company) with an intra-vaginal tablet once daily while the control group will receive placebo. Both women and medical staff will be blinded to group allocation. Treatment will commence on the day of inclusion to the study, but not before 16 weeks and will continue until 36 weeks gestation. Data will be collected after the conclusion of pregnancy regarding the maternal and neonatal outcome.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 128 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →HaEmek Medical Center, Israel is the lead sponsor of 228 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: micronized progesterone 200 mg (Utrogestan)
Drug: placebo
micronized progesterone 200 mg (Utrogestan, company) as an intra-vaginal tablet once daily
placebo 200mg vaginal tablets
Incidence of spontaneous preterm birth - before 37 weeks.
Time frame: 3 years
Maternal and fetal outcomes
Time frame: 3 years
This study is terminated, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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HaEmek Medical Center, Israel