Cervical pessary to reduce preterm birth <34 weeks of gestation after an episode of preterm labor and a short cervix: a randomized controlled trial

Abstract

Background: To date, no intervention has proved effective in reducing the spontaneous preterm birth rate in singleton pregnancies following an episode of threatened preterm labor and short cervix remaining.

Objective: This study was designed to ascertain whether cervical pessaries could be useful in preventing spontaneous preterm birth in women with singleton pregnancies and a short cervix after a threatened preterm labor episode.

Study design: This open randomized controlled trial was conducted in 357 pregnant women (between 24⁰-33⁶ weeks) who had not delivered 48 hours after a threatened preterm labor episode and had a short cervix remaining (≤25 mm at 24⁰-29⁶ weeks; ≤15 mm at 30⁰-33⁶ weeks). Patients were randomly assigned to cervical pessary (179) or routine management (178). The primary outcome was the spontaneous preterm birth rate <34 weeks. Spontaneous preterm birth <28 and 37 weeks and neonatal morbidity and mortality were also evaluated in an intention-to-treat analysis.

Results: No significant differences between the pessary and routine management groups were observed in the spontaneous preterm birth rate <34 weeks (19/177 [10.7%] in the pessary group vs 24/175 [13.7%] in the control group; relative risk, 0.78; 95% confidence interval, 0.45-1.38). Spontaneous preterm birth <37 weeks occurred less frequently in the pessary group (26/175 [14.7%] vs 44/175 [25.1%]; relative risk, 0.58; 95% confidence interval, 0.38-0.90; P = .01). Preterm premature rupture of membranes rate was significantly lower in pessary carriers (4/177 [2.3%] vs 14/175 [8.0%]; relative risk, 0.28; 95% confidence interval, 0.09-0.84; P = .01). The pessary group less frequently required readmission for new threatened preterm labor episodes (8/177 [4.5%] vs 35/175 [20.0%]; relative risk, 0.23; 95% confidence interval, 0.11-0.47; P < .0001). No serious adverse maternal events occurred; neonatal morbidity and mortality were similar in both groups.

Conclusion: Pessary use did not significantly lower the spontaneous preterm birth rate <34 weeks in women with a short cervix remaining after a threatened preterm labor episode but did significantly reduce the spontaneous preterm birth rate <37 weeks, threatened preterm labor recurrence, and the preterm premature rupture of membranes rate.

Keywords: arabin pessary; arrested preterm labor; cervical pessary; fetal maturation; high-risk pregnancy; neonatal morbidity; preterm birth; preterm birth prevention; respiratory distress syndrome; short cervical length; short cervix; singleton pregnancy; threatened preterm labor; tocolysis; tocolytic treatment.