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.

• Authors: S-J Choi, D W Kwak, K Kil, S-C Kim, J-Y Kwon, Y H Kim, S Na, J-G Bae, H-H Cha, J-Y Shim, K Y Oh, K A Lee, S M Kim, I A Cho, S M Lee, G J Cho, Y S Jo, G Y Choi, S K Choi, S E Hur, H S Hwang, Y J Kim, from The Preterm Birth Research Committee of the Korean Society of Maternal Fetal Medicine
• Journal: BJOG : an international journal of obstetrics and gynaecology (BJOG) Vol. 127 Issue 13 Pg. 1646-1654 (12 2020) ISSN: 1471-0528 [Electronic] England
• PMID: 32536019 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2020 Royal College of Obstetricians and Gynaecologists.

Chemical References

• Progestins

Topics

• Administration, Intravaginal
• Adult
• Female
• Humans
• Injections, Intramuscular
• Meta-Analysis as Topic
• Pregnancy
• Pregnancy, High-Risk
• Premature Birth (prevention & control)
• Progestins (administration & dosage)