@article{12504aaeda7c4b3a973e962eed276842,
title = "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",
abstract = "Objective: To compare the efficacy of two types of progestogen therapy for preventing preterm birth (PTB) and to review the relevant literature. Design: A multicentre, randomised, open-label, equivalence trial and a meta-analysis. Setting: Tertiary referral hospitals in South Korea. Population: Pregnant women with a history of spontaneous PTB or short cervical length (<25 mm). Methods: Eligible women were screened and randomised at 16‒22 weeks of gestation to receive either 200 mg of vaginal micronised progesterone daily (vaginal group) or an intramuscular injection of 250 mg 17α-hydroxyprogesterone caproate weekly (IM group). Stratified randomisation was carried out according to participating centres and indications for progestogen therapy. This trial was registered at ClinicalTrials.gov (NCT02304237). Main outcome measure: Preterm birth (PTB) before 37 weeks of gestation. Results: A total of 266 women were randomly assigned and a total of 247 women (119 and 128 women in the vaginal and IM groups, respectively) were available for the intention-to-treat analysis. Risks of PTB before 37 weeks of gestation did not significantly differ between the two groups (22.7 versus 25.8%, P = 0.571). The difference in PTB risk between the two groups was 3.1% (95% CI −7.6 to 13.8%), which was within the equivalence margin of 15%. The meta-analysis results showed no significant differences in the risk of PTB between the vaginal and IM progestogen treatments. Conclusion: Compared with vaginal progesterone, treatment with intramuscular progestin might increase the risk of PTB before 37 weeks of gestation by as much as 13.8%, or reduce the risk by as much as 7.6%, in women with a history of spontaneous PTB or with short cervical length. Tweetable abstract: Vaginal and intramuscular progestogen showed equivalent efficacy for preventing preterm birth before 37 weeks of gestation.",
keywords = "Preterm birth, prevention, progestogen, short cervical length",
author = "{from The Preterm Birth Research Committee of the Korean Society of Maternal Fetal Medicine} and Choi, {S. J.} and Kwak, {D. W.} and K. Kil and Kim, {S. C.} and Kwon, {J. Y.} and Kim, {Y. H.} and S. Na and Bae, {J. G.} and Cha, {H. H.} and Shim, {J. Y.} and Oh, {K. Y.} and Lee, {K. A.} and Kim, {S. M.} and Cho, {I. A.} and Lee, {S. M.} and Cho, {G. J.} and Jo, {Y. S.} and Choi, {G. Y.} and Choi, {S. K.} and Hur, {S. E.} and Hwang, {H. S.} and Kim, {Y. J.}",
note = "Funding Information: This study was supported by a grant (HI14C0306) from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea, and was funded and supported by Besins Healthcare and Han Wha Pharma Co., Ltd. Funding Information: This study was supported by a grant (HI14C0306) from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea, and funded and supported by Besins Healthcare and Han Wha Pharma Co., Ltd. This study was supported by a grant (HI14C0306) from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea, and was funded and supported by Besins Healthcare and Han Wha Pharma Co., Ltd. The authors thank Soon Young Hwang (Department of Biostatistics, Korea University College of Medicine) who performed the meta-analysis. Funding Information: The authors report grants from a Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), non‐financial support from Besins Healthcare and non‐financial support from Han Wha Pharma Co., Ltd, during the conduct of the study. Completed disclosure of interest forms are available to view online as supporting information. Publisher Copyright: {\textcopyright} 2020 Royal College of Obstetricians and Gynaecologists",
year = "2020",
month = dec,
doi = "10.1111/1471-0528.16365",
language = "English",
volume = "127",
pages = "1646--1654",
journal = "BJOG: An International Journal of Obstetrics and Gynaecology",
issn = "1470-0328",
publisher = "Wiley-Blackwell Publishing Ltd",
number = "13",
}