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Progesterone and Second Trimester Bleeding

NCT01269450 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2018-06-06

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • HaEmek Medical Center, Israel

    lead OTHER

Principal Investigators

  • RAED SALIM, MD · HaEmek medical center affiliated to the Rappaport faculty of medicine, Technion, Haifa, Israel

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2017-01-31
Completion
2017-07-31

Countries

  • Israel

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01269450 on ClinicalTrials.gov