Cervical Incompetence Prevention Randomized Cerclage Trial (CIPRACT): Study design and preliminary results

OBJECTIVE: The objective of this study was to compare different management strategies for women at risk for cervical incompetence. STUDY DESIGN: In an ongoing randomized trial patients with a previous prete rm delivery at <34 weeks' gestation who met clinical criteria for the diagn osis of cervical incompetence are allocated to receive a prophylactic cercl age (prophylactic cerclage group) or not (observational group) in a proport ion of 1.2. Transvaginal ultrasonographic follow-up examination of the cerv ix is performed in both groups. When a patient of the latter group has a ce rvical length <25 mm at <27 weeks' gestation, a further random assignment o f therapeutic cerclage or no cerclage is performed. The analysis is by inte nt to treat. RESULTS: Primary random assignment allocated 23 women to the prophylactic c erclage group and 44 to the observational group. Both groups were comparabl e with respect to obstetric history. No significant difference was found be tween the prophylactic cerclage group and the observational group in preter m delivery at <34 weeks' gestation (3/23 vs 6/44, respectively) and neonata l survival (21/23 vs 41/44, respectively). A cervical length <25 mm was fou nd in 18 patients (41%) in the observational group at a mean gestational ag e of 19.1 +/- 2.9 weeks' gestation. Incidence of preterm delivery at <34 we eks' gestation was significantly higher in the group with short cervical le ngth (6/18 vs 0/26; P = .003). Secondary random assignment of the 18 patien ts with short cervical length allocated 10 to undergo therapeutic cerclage. Preterm delivery at <34 weeks' gestation was significantly less frequent i n the therapeutic cerclage group (1/10 vs 5/8). CONCLUSION: Transvaginal ultrasonographic serial follow-up examinations of the cervix in women at risk for cervical incompetence, with secondary inter vention as indicated, appears to be a safe alternative to the traditional p rophylactic cerclage. Transvaginal ultrasonographic follow-up examination o f the cervix can save the majority of women from unnecessary intervention. Placement of a therapeutic cerclage may reduce the incidence of preterm del ivery at <34 weeks' gestation among high-risk patients.