• Profile
Close

Cervical pessary compared with vaginal progesterone for preventing early preterm birth: A randomized controlled trial

Obstetrics and Gynecology Sep 28, 2018

Cruz-Melguizo S, et al. - In this multicenter, open-label, randomized, noninferiority trial, researchers investigated how a cervical pessary differs from vaginal progesterone when used as a preventive against spontaneous preterm births in pregnant women with cervical lengths 25 mm or less. According to findings, compared with vaginal progesterone, a cervical pessary was not noninferior for preventing spontaneous birth before 34 weeks of gestation in pregnant women with short cervixes.

Methods

  • Participants included women with singleton pregnancies and a short cervix (25 mm or less) measured by transvaginal ultrasonography at the second-trimester ultrasonogram.
  • Via computer-randomization (1:1), these subjects were randomized into cervical pessary placement or treatment with vaginal progesterone (200 mg/24 hours).
  • Researchers focused on spontaneous preterm delivery before 34 weeks of gestation (primary outcome).
  • The noninferiority margin was set at 4% with a 0.025 one-sided α level and a statistical power of 80%; that is, if the 95% CI upper bound exceeded 4%, the pessary could not be deemed noninferior.
  • To demonstrate noninferiority of the pessary to progesterone, they needed a sample size of 254 women.

Results

  • Twenty-seven Spanish hospitals participated in this trial conducted from August 2012 to April 2016.
  • There were 254 enrolled subjects, and the intention-to-treat analysis included 246 subjects.
  • A similarity in demographic and baseline characteristics was observed across groups.
  • The estimated rate of spontaneous delivery before 34 weeks of gestation in the pessary group and in the progesterone group was 14% (n=18/127) and 14% (n=17/119), respectively, with a risk difference of -0.11% (95% CI -8.85% to 8.62%; P=.99).
  • The pessary group had a significantly higher incidence of increased vaginal discharge (87% vs 71%, P=.002) and discomfort (27% vs 3%, P<.001).
Go to Original
Only Doctors with an M3 India account can read this article. Sign up for free or login with your existing account.
4 reasons why Doctors love M3 India
  • Exclusive Write-ups & Webinars by KOLs

  • Nonloggedininfinity icon
    Daily Quiz by specialty
  • Nonloggedinlock icon
    Paid Market Research Surveys
  • Case discussions, News & Journals' summaries
Sign-up / Log In
x
M3 app logo
Choose easy access to M3 India from your mobile!


M3 instruc arrow
Add M3 India to your Home screen
Tap  Chrome menu  and select "Add to Home screen" to pin the M3 India App to your Home screen
Okay