Premature Birth
Conditions
Keywords
Premature Birth, progesterone
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, adverse effects and patient preference of two different regimens of progesterone therapy. Design: Multi-center, randomized, open-label trial
Interventions
DRUGVaginal progesterone
micronized progesterone 200mg/day till 36 weeks 6 days of gestation or premature rupture of membranes
hydroxyprogesterone caproate 250mg/ml/week till 36 weeks 6 days of gestation or premature rupture of membranes
Sponsors
Samsung Medical Center
Han Wha Pharma Co., Ltd.
Ministry of Health & Welfare, Korea
Ewha Womans University Mokdong Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Preterm Birth Rate before 37 weeks of gestation | from study enrollment to maximum 37 weeks of gestation |
Secondary
| Measure | Time frame |
|---|---|
| Preterm Birth Rate before 34 weeks of gestation | from study enrollment to maximum 34 weeks of gestation |
| Preterm Birth Rate before 28 weeks of gestation | from study enrollment to maximum 28 weeks of gestation |
| Result of birth(rate of death, weight, cause of hospitalization to NICU) | from study enrollment to maximum 37 weeks of gestation |
| Any complications occurred to newborn and mother | from study enrollment to maximum 37 weeks of gestation |
Contacts
Primary ContactYoung Ju Kim
Backup ContactSUK-JOO CHOI
Outcome results
None listed