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#Grand Rounds

PoPPS Study: Does Pessary Use In Women with a Short Cervical Length Prevent Preterm Birth?

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BACKGROUND AND PURPOSE:

  • Transvaginal cervical length is a predictor for spontaneous preterm birth (SPTB)
  • In singleton pregnancies without PTB, vaginal progesterone prevents SPTB
    • Prior PTB, and cervical length < 25mm, cerclage associated with prevention of recurrence
  • RCT data on pessaries for SPTB prevention are contradictory
  • Dugoff et al. (Ultrasound Obstet Gynecol, 2017) assessed if pessary use prevents preterm birth in singleton gestations with short cervical length and no SPTB history

METHODS:

  • Open-label multicenter randomized trial of asymptomatic singleton births (2014-2016)
  • Inclusion criteria
    • Transvaginal ultrasound cervical length ≤ 25 mm at 18w0d-23w6d
    • No prior spontaneous preterm birth
    • No complications (e.g., ruptured membranes, fetal anomalies, bleeding)
  • Subjects were randomized to receive either
    • Bioteque cup pessary
    • No pessary
  • Vaginal progesterone was recommended to women with a cervical length ≤20mm
  • Primary outcome was preterm birth < 37 weeks
  • Secondary outcomes
    • PTB <34, <28 and <24 weeks; SPTB <37, <34, <28 and <24 weeks; gestational age at delivery; birth weight; chorioamnionitis; genitourinary infections; intrauterine fetal demise and cesarean delivery
    • Adverse neonatal outcomes were also assessed including neonatal death (birth to 28 days of age) as well as a composite adverse outcome measure
  • NOTE: The trial was stopped early before complete enrollment
    • Two primary sites halted enrollment due to competing NICHD studies after their inclusion in to the NICHD MFM network

RESULTS:

  • 391 (92.7 %) women met eligibility criteria and 122 (31.2 %) agreed to randomization
  • Baseline characteristics were similar between pessary and no pessary groups
  • There were no significant differences between the pessary and no pessary groups in rates of preterm birth <37 weeks (43% vs 40%, relative risk 1.09, 95% CI 0.71-1.68),
  • There were no significant differences in secondary outcomes

CONCLUSION:

  • Possible reasons that there was no difference in outcomes
    • Progesterone use
    • Enrolled women without previous SPTB but still may be a high-risk population
    • Earlier gestational age at time of enrollment / African American inner city population
    • PPROM rate higher than other RCTs
    • Present study used Bioteque and not Arabin pessary
    • Small sample size due to interruption of study prior to complete enrollment
  • Pessary use was not associated with a decreased risk for preterm birth for singleton asymptomatic gestations with short transvaginal ultrasound cervical length without prior spontaneous preterm birth

Learn More – Primary Sources:

Prevention of Preterm Birth with Pessary in Singletons (PoPPS): a randomized controlled trial.

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Related ObG Topics:

Does fetal fibronectin testing prevent preterm birth?
Does Socioeconomic Status Affect Risk of Adverse Birth Outcomes?
SMFM Statement: Choice of Progestogen for Preterm Birth Prevention
17-OHPC Treatment and Prevention of Preterm Birth: Does Timing Matter?
Does the Uterocervical Angle on Ultrasound Impact Rate of Preterm Birth?

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