Vaginal Compared With Intramuscular Progesterone for Prevention of Preterm Birth in High Risk Pregnant Women

Phase 3 Unknown 360 enrolled Ewha Womans University Mokdong Hospital Han Wha Pharma Co., Ltd. · collab Ministry of Health & Welfare, Korea · collab Samsung Medical Center · collab

RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start: 2014-12
Primary completion: 2016-11
Completion: 2016-12

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	17-alpha-hydroxyprogesterone caproate	Unknown	250 mg	Intramuscular
Subject	Progesterone	Other / unclassified	200 mg	Other

Indications

No indication recorded.