NCT01269450

Progesterone and Second Trimester Bleeding

The Impact of Progesterone on the Risk of Preterm Birth Among Women With Second Trimester Bleeding. A Double Blind Placebo Controlled Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: HaEmek Medical Center, Israel · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Antepartum Bleeding
• Preterm Birth

Interventions

Type	Name	Description
DRUG	micronized progesterone 200 mg (Utrogestan)	micronized progesterone 200 mg (Utrogestan, company) as an intra-vaginal tablet once daily
DRUG	placebo	placebo 200mg vaginal tablets

Timeline

• Start date: 2011-03-01
• Primary completion: 2017-01-01
• Completion: 2017-07-01
• First posted: 2011-01-04
• Last updated: 2018-06-06

Locations

3 sites across 1 country: Israel