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

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ewha Womans University Mokdong Hospital
• Collaborators: Han Wha Pharma Co., Ltd.; Ministry of Health & Welfare, Korea; Samsung Medical Center
• Treatments: Progesterone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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