Progesterone and Second Trimester Bleeding

Not Applicable

Terminated

• Conditions: Antepartum Bleeding; Preterm Birth
• Interventions: Drug: placebo; Drug: micronized progesterone 200 mg (Utrogestan)

• Registration Number: NCT01269450
• Lead Sponsor: HaEmek Medical Center, Israel

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-03
• Study First Submitted QC: 2011-01-03
• Study First Posted: 2011-01-04
• Study Start: 2011-03
• Primary Completion: 2017-01
• Study Completion: 2017-07
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-05
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 128

Inclusion Criteria

• Viable pregnancy
• Gestational age between 13 to 26 weeks
• Vaginal bleeding from uterine origin
• Singleton pregnancy
• Normal clotting tests
• Hemodynamically stable woman

Exclusion Criteria

• Water leak
• Signs of preterm labor
• Fetal malformations incompatible with life
• Uterine malformations and other maternal conditions, i.e. liver disease, breast cancer, active thromboembolic state
• Past preterm birth

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
Utrogestan	micronized progesterone 200 mg (Utrogestan)	-

Primary Outcome Measures

Name	Time	Method
Incidence of spontaneous preterm birth - before 37 weeks.	3 years

Secondary Outcome Measures

Name	Time	Method
Maternal and fetal outcomes	3 years

Trial Locations

Locations (3)

Emek medical center; 🇮🇱 Afula, Israel

Dep. OB/GYN, The Nazareth Hospital, E.M.M.S; 🇮🇱 Nazareth, Israel

dEP ob/gyn, Hillel Yaffe Medical Center.; 🇮🇱 Hadera, Israel