MedTrace Logo

Vaginal Compared With Intramuscular Progesterone for Prevention of Preterm Birth in High Risk Pregnant Women

NCT02304237 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2014-12-01

No results posted yet for this study

Summary

This study is for compare the efficacy of two different regimens(vaginal vs intramuscular) of progesterone therapy in prevention of preterm birth in high risk pregnant women.

Conditions

  • Premature Birth

Interventions

DRUG

Vaginal progesterone

micronized progesterone 200mg/day till 36 weeks 6 days of gestation or premature rupture of membranes

DRUG

Intramuscular progesterone

hydroxyprogesterone caproate 250mg/ml/week till 36 weeks 6 days of gestation or premature rupture of membranes

Sponsors & Collaborators

  • Ewha Womans University Mokdong Hospital

    lead OTHER

  • Samsung Medical Center

    collaborator OTHER

  • Han Wha Pharma Co., Ltd.

    collaborator INDUSTRY

  • Ministry of Health & Welfare, Korea

    collaborator OTHER_GOV

Principal Investigators

  • Young Ju Kim · Ewha Womans University Mokdong Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-11-30
Completion
2016-12-31

More Related Trials

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 NCT02304237 on ClinicalTrials.gov