Vaginal Compared With Intramuscular Progesterone for Prevention of Preterm Birth in High Risk Pregnant Women
Information source: Ewha Womans University Mokdong Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Premature Birth
Intervention: Vaginal progesterone (Drug); Intramuscular progesterone (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Ewha Womans University Mokdong Hospital Official(s) and/or principal investigator(s): Young Ju Kim, Principal Investigator, Affiliation: Ewha Womans University Mokdong Hospital
Overall contact: Young Ju Kim, Phone: 822-2650-5500, Email: kkyj@ewha.ac.kr
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.
Clinical Details
Official title: A Multicenter, Randomized, Open-label, Investigator Initiated Trial of Vaginal Compared With Intramuscular Progesterone for Prevention of Preterm Birth in High Risk Pregnant Women
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Preterm Birth Rate before 37 weeks of gestation
Secondary outcome: Preterm Birth Rate before 34 weeks of gestationPreterm Birth Rate before 28 weeks of gestation Result of birth(rate of death, weight, cause of hospitalization to NICU) Any complications occurred to newborn and mother
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, adverse effects and patient preference of two different regimens
of progesterone therapy.
Design: Multi-center, randomized, open-label trial
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Young Ju Kim, Phone: 822-2650-5500, Email: kkyj@ewha.ac.kr Additional Information
Starting date: December 2014
Last updated: November 26, 2014
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