Cervical Incompetence Prevention Randomized Cerclage Trial (CIPRACT): effect of therapeutic cerclage with bed rest vs. bed rest only on cervical length.

OBJECTIVE: To compare the effects of therapeutic cerclage and bed rest vs. just bed rest on cervical length and to relate these effects to the risk of preterm delivery.
DESIGN: Cervical length was measured in patients at high risk of cervical incompetence. When a cervical length < 25 mm was measured before 27 weeks' gestation, randomization for therapeutic cerclage and bed rest vs. just bed rest was performed. After randomization, cervical length was measured weekly. For statistical analysis, t-test and Fisher's exact tests were used and P < 0.05 was considered statistically significant.
RESULTS: Nineteen women were randomly allocated to receive a therapeutic cerclage and bed rest and 16 were allocated to receive bed rest only. Mean cervical lengths and mean gestational ages before randomization were comparable between both groups, overall 19.8 mm and 20.7 weeks. Cervical length was measured again at a mean gestation of 22.1 weeks. Mean cervical length (31 mm) was significantly (P < 0.0001) longer after cerclage than after bed rest only (19 mm). A cervical length > or = 25 mm was measured in 22 of the 35 included women, 16 in the cerclage group and six in the bed-rest group (P = 0.006). Of these 22 women, only one delivered before 34 weeks' gestation, which was significantly less frequent than six out of 13 women with a cervical length < 25 mm (P = 0.006).
CONCLUSIONS: Therapeutic cerclage with bed rest increases cervical length more often than bed rest alone. A postintervention cervical length > or = 25 mm reduces the risk of preterm delivery in women at high risk of cervical incompetence and a preintervention cervical length < 25 mm.

RCT Entities:   Population Interventions Outcomes