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Cervical Pessary After Arrested Preterm Labor: A Randomized Controlled Trial
Frederik J R Hermans1, Ewoud Schuit, Mireille N Bekker
1Departments of Obstetrics and Gynecology, Academic Medical Center, Amsterdam, University Medical Center Utrecht, Utrecht, Radboud University Nijmegen Medical Center, Nijmegen, VU Medical Center, Amsterdam, Leiden University Medical Center, Leiden, Maastricht University Medical Center, Maastricht, and University Medical Center Groningen, Groningen, the Netherlands, and Monash University, Monash Medical Centre, Clayton, Victoria, Australia; and the Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.
A cervical pessary did not reduce preterm birth rates in high-risk women after threatened preterm labor. This study found no effectiveness for cervical pessary intervention in preventing early delivery.
Area of Science:
- Maternal-fetal medicine
- Obstetrics
- Perinatology
Background:
- Preterm birth remains a leading cause of neonatal morbidity and mortality.
- Identifying effective interventions for women at high risk of preterm birth is crucial.
- Women experiencing threatened preterm labor require strategies to prolong gestation.
Purpose of the Study:
- To evaluate the efficacy of a cervical pessary in preventing preterm birth.
- To assess the impact of cervical pessary on adverse neonatal outcomes.
- To determine the effectiveness of pessary use in high-risk pregnancies post-threatened preterm labor.
Main Methods:
- A multicenter, open-label, randomized controlled trial compared cervical pessary to no intervention.
- Eligible participants were women (24-34 weeks gestation) with high-risk factors for preterm birth.
- The primary outcome was delivery before 37 weeks gestation; secondary outcomes included adverse neonatal events.
Main Results:
- The study was stopped early for futility after enrolling 130 women.
- Preterm birth before 37 weeks occurred in 48% of the pessary group versus 39% in the control group.
- No significant difference was observed in composite adverse perinatal outcomes between groups.
Conclusions:
- Cervical pessary treatment was found to be ineffective in reducing preterm birth rates.
- The intervention did not improve neonatal outcomes in this high-risk population.
- Further research may be needed to explore alternative strategies for preventing preterm birth in similar cases.
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