Vaginal Compared With Intramuscular Progesterone for Prevention of Preterm Birth in High Risk Pregnant Women
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|ClinicalTrials.gov Identifier: NCT02304237|
Recruitment Status : Unknown
Verified November 2014 by Young Ju Kim, Ewha Womans University Mokdong Hospital.
Recruitment status was: Not yet recruiting
First Posted : December 1, 2014
Last Update Posted : December 1, 2014
|Condition or disease||Intervention/treatment||Phase|
|Premature Birth||Drug: Vaginal progesterone Drug: Intramuscular progesterone||Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||December 2014|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||December 2016|
Experimental: Vaginal progesterone
Vaginal progesterone(Utrogestan)200mg/day, during 14~21 weeks.
Drug: Vaginal progesterone
micronized progesterone 200mg/day till 36 weeks 6 days of gestation or premature rupture of membranes
Other Name: Utrogestan
Active Comparator: Intramuscular progesterone
Intramuscular progesterone(Progesterone Depot Jenapharm Injection)250mg/week, during 14~21 weeks.
Drug: Intramuscular progesterone
hydroxyprogesterone caproate 250mg/ml/week till 36 weeks 6 days of gestation or premature rupture of membranes
Other Name: Progesterone Depot Jenapharm Injection
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02304237
|Contact: Young Ju Kimemail@example.com|
|Contact: SUK-JOO CHOIfirstname.lastname@example.org|
|Principal Investigator:||Young Ju Kim||Ewha Womans University Mokdong Hospital|