Cerclage pessary for preventing preterm birth in women with a singleton pregnancy and a short cervix at 20 to 24 weeks: a randomized controlled trial
American Journal of Perinatology, 08/09/2012
Hui SYA et al. – In the population, <5% had a cervical length of less than 25 mm at 20 to 24 weeks' gestation. The prophylactic use of cerclage pessary did not reduce the rate of preterm delivery before 34 weeks.Methods
- Low–risk women carrying singleton pregnancies were screened with transvaginal ultrasound, and those with a cervical length <25 mm at 20 to 24 weeks were recruited into a randomized controlled trial, comparing the prophylactic use of cerclage pessary with expectant management.
- The analysis was by intent–to–treat.
- The primary outcome measure was preterm delivery before 34 weeks.
- Among 4438 screened women, 203 women (4.6%) met the inclusion criteria and 108 (58%) consented for the study.
- A total of 53 and 55 women were allocated to pessary and control groups, respectively.
- There was no difference in background demographics, including the mean cervical length (19.6 mm versus 20.5 mm) and the mean gestational age at randomization (both 21.9 weeks).
- Delivery before 34 weeks occurred in 9.4% and 5.5% (p = 0.46) in the pessary and the control groups, respectively.
- No differences in major side effects were noted between the groups.