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| Name | Class |
|---|---|
| Samsung Medical Center | OTHER |
| Han Wha Pharma Co., Ltd. | INDUSTRY |
| Ministry of Health & Welfare, Korea | OTHER_GOV |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal progesterone | Experimental | Vaginal progesterone(Utrogestan)200mg/day, during 14~21 weeks. |
|
| Intramuscular progesterone | Active Comparator | Intramuscular progesterone(Progesterone Depot Jenapharm Injection)250mg/week, during 14~21 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal progesterone | Drug | micronized progesterone 200mg/day till 36 weeks 6 days of gestation or premature rupture of membranes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Preterm Birth Rate before 37 weeks of gestation | from study enrollment to maximum 37 weeks of gestation |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Young Ju Kim | Contact | 822-2650-5500 | kkyj@ewha.ac.kr | |
| SUK-JOO CHOI | Contact | 822-3410-3546 | drmaxmix.choi@samsung.com |
| Name | Affiliation | Role |
|---|---|---|
| Young Ju Kim | Ewha Womans University Mokdong Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32536019 | Derived | Choi SJ, Kwak DW, Kil K, Kim SC, Kwon JY, Kim YH, Na S, Bae JG, Cha HH, Shim JY, Oh KY, Lee KA, Kim SM, Cho IA, Lee SM, Cho GJ, Jo YS, Choi GY, Choi SK, Hur SE, Hwang HS, Kim YJ; from The Preterm Birth Research Committee of the Korean Society of Maternal Fetal Medicine. Vaginal compared with intramuscular progestogen for preventing preterm birth in high-risk pregnant women (VICTORIA study): a multicentre, open-label randomised trial and meta-analysis. BJOG. 2020 Dec;127(13):1646-1654. doi: 10.1111/1471-0528.16365. Epub 2020 Jul 14. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000624167 | Utrogestan |
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| Intramuscular progesterone | Drug | hydroxyprogesterone caproate 250mg/ml/week till 36 weeks 6 days of gestation or premature rupture of membranes |
|
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| 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 |
| D000091642 | Urogenital Diseases |