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#Grand Rounds

VICTORIA RCT Results: IM vs Vaginal Progestogen for Preterm Birth

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BACKGROUND AND PURPOSE: 

  • Two forms of progestogen therapy, IM 17-OHPC and vaginal micronized natural progesterone, are used for the prevention of preterm birth (PTB) 
  • Choi et al. (BJOG, 2020) compared the efficacy of IM vs vaginal progestogen therapy  

METHODS: 

  • Multicenter, randomized, open-label, equivalence trial and a meta-analysis
  • Participants
    • Pregnant women with a history of spontaneous PTB and/or short cervical length (<25 mm)
  • Interventions
    • Vaginal group: 200 mg of vaginal micronized progesterone daily
    • IM group: intramuscular injection of 250 mg 17-OHPC weekly
  • Primary outcome
    • PTB before <37 weeks
  • Results of this study were included in a meta-analysis of other RCTs that compared the 2 interventions

RESULTS: 

  • Vaginal group: 119 women | IM group: 128 women
  • Risks of PTB <37 weeks of gestation did not significantly differ between the two groups (P=0.571)
    • Vaginal: 22.7%
    • IM: 25.8%
  • The difference in PTB risk between the two groups was within the equivalence margin of 15%
    • 3.1% (95% CI, −7.6 to 13.8%)
  • Likewise, no differences were seen at <34 weeks or <28 weeks
    • <34 weeks: adjusted relative risk (RR): 1.522 (95% CI, 0.741 to 3.126)
    • <28 weeks: aRR: 2.088 (95% CI, 0.658 to 6.626)
  • Meta-analysis (current study plus 5 additional RCTs) showed no significant differences in the risk of PTB between the vaginal and IM progestogen treatments

CONCLUSION: 

  • Vaginal and IM progestogen demonstrated the same efficacy at preventing preterm birth 
  • The authors acknowledge that a significant limitation is combining indications (previous PTB and short cervix) 
    • Subgroup analysis did not demonstrate differences, however sample size was too small to draw a definitive conclusion   

Learn More – Primary Sources: 

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 

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Related ObG Topics:

Do Progestogens Prevent Preterm Birth in Symptomatic Pregnancies with a Short Cervix?
Short Cervix and Risk for Preterm Birth: Do Pessaries Work? 
Does a Weekly Dose of 17-OHPC Improve Outcomes in the Setting of Preterm Ruptured Membranes?

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