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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
360
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
Preterm Birth Rate before 37 weeks of gestation
Time frame: from study enrollment to maximum 37 weeks of gestation
Preterm Birth Rate before 34 weeks of gestation
Time frame: from study enrollment to maximum 34 weeks of gestation
Preterm Birth Rate before 28 weeks of gestation
Time frame: from study enrollment to maximum 28 weeks of gestation
Result of birth(rate of death, weight, cause of hospitalization to NICU)
Time frame: from study enrollment to maximum 37 weeks of gestation
Any complications occurred to newborn and mother
Time frame: from study enrollment to maximum 37 weeks of gestation
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