Final results of the Cervical Incompetence Prevention Randomized Cerclage Trial (CIPRACT): Therapeutic cerclage with bed rest versus bed rest alone

OBJECTIVE: To compare preterm delivery rates (before 34 weeks of gestation) and neonatal morbidity and mortality in patients with risk factors or symp toms of cervical incompetence managed with therapeutic McDonald cerclage an d bed rest versus bed rest alone. STUDY DESIGN: Cervical length was measured in patients with risk factors or symptoms of cervical incompetence. Risk factors for cervical incompetence included previous preterm delivery before 34 weeks of gestation that met cl inical criteria for the diagnosis of cervical incompetence, previous preter m premature rupture of membranes before 32 weeks of gestation, history of c old knife conization, diethylstilbestrol exposure, and uterine anomaly. Whe n a cervical length of < 25 mm was measured before a gestational age of 27 weeks, a randomization for therapeutic cerclage and bed rest (cerclage grou p) or bed rest alone (bed rest group) was performed. The analysis is based on intention to treat. RESULTS: Of the 35 women who met the inclusion criteria, 19 were allocated randomly to the cerclage group and 16 to the bed rest group. Both groups we re comparable for mean cervical length and mean gestational age at time of randomization, mean overall 20 mm and 21 weeks. Preterm delivery before 34 weeks was significantly more frequent in the bed rest group than in the cer clage group (7 of 16 vs none, respectively; P = .002). There was no statist ically significant difference in neonatal survival between the groups (13 n eonates survived in the bed rest group vs all in the cerclage group). The c ompound neonatal morbidity, defined as admission to the neonatal intensive care unit or neonatal death, was significantly higher in the bed rest group than in the cerclage group (8 of 16 vs 1 of 19, respectively; P = .005; RR = 9.5, 95% Cl, 1.3-68.1). CONCLUSIONS: Therapeutic cerclage with bed rest reduces preterm delivery be fore 34 weeks of gestation and compound neonatal morbidity in women with ri sk factors and/or symptoms of cervical incompetence and a cervical length o f < 25 mm before 27 weeks of gestation.