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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
Author(s) -
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
Publication year - 2020
Publication title -
bjog: an international journal of obstetrics and gynaecology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.157
H-Index - 164
eISSN - 1471-0528
pISSN - 1470-0328
DOI - 10.1111/1471-0528.16365
Subject(s) - medicine , obstetrics , progestogen , gynecology , gestation , pregnancy , randomized controlled trial , population , relative risk , confidence interval , hormone , environmental health , biology , genetics
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.