Clinical trial NCT02304237: Vaginal Compared With Intramuscular Progesterone for Prevention of Preterm Birth in High Risk Pregnant Women
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Premature Birth
Keywords: Premature Birth
progesterone
Lead sponsor: Ewha Womans University Mokdong Hospital
Sponsor class: OTHER
Collaborators: name: Samsung Medical Center
name: Han Wha Pharma Co., Ltd.
name: Ministry of Health & Welfare, Korea
First posted: 2014-12-01
Enrollment: 360
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility 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

Primary outcomes:
measure: Preterm Birth Rate before 37 weeks of gestation
timeFrame: from study enrollment to maximum 37 weeks of gestation
Secondary outcomes:
measure: Preterm Birth Rate before 34 weeks of gestation
timeFrame: from study enrollment to maximum 34 weeks of gestation
measure: Preterm Birth Rate before 28 weeks of gestation
timeFrame: from study enrollment to maximum 28 weeks of gestation
measure: Result of birth(rate of death, weight, cause of hospitalization to NICU)
timeFrame: from study enrollment to maximum 37 weeks of gestation
measure: Any complications occurred to newborn and mother
timeFrame: from study enrollment to maximum 37 weeks of gestation
Other outcomes:
Locations:
Study officials:
affiliation: Ewha Womans University Mokdong Hospital
name: Young Ju Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.