Status:
UNKNOWN
Vaginal Compared With Intramuscular Progesterone for Prevention of Preterm Birth in High Risk Pregnant Women
Lead Sponsor:
Ewha Womans University Mokdong Hospital
Collaborating Sponsors:
Samsung Medical Center
Han Wha Pharma Co., Ltd.
Conditions:
Premature Birth
Eligibility:
FEMALE
20+ years
Phase:
PHASE3
Brief 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.
Detailed Description
The objectives of this study is 1) To compare the efficacy of two different regimens of progesterone therapy in preventing preterm birth less than 37 weeks of gestation. 2) To compare the cost-benefit...
Eligibility Criteria
Inclusion
- With a history of prior spontaneous preterm birth or short cervix length
- Spontaneous preterm birth: preterm birth \<37 weeks of gestation due to spontaneous preterm labor or preterm premature rupture of membranes (PPROM)
- Short Cervix length : cervix length \<25 mm as measured by transvaginal ultrasound at 16-24 weeks of gestation
Exclusion
- Multiple gestations
- Major congenital anomalies
- Elective prophylactic cervical cerclage \<16 weeks of gestation during current pregnancy
- Previous intentional preterm birth due to maternal or fetal indications, such as preeclampsia and fetal growth restriction
- Diabetes, hypertension, other severe medical diseases
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT02304237
Start Date
December 1 2014
End Date
December 1 2016
Last Update
December 1 2014
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