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Cervical incompetence prevention randomized cerclage trial (CIPRACT): study design and preliminary results.

Abstract：

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 preterm delivery at <34 weeks' gestation who met clinical criteria for the diagnosis of cervical incompetence are allocated to receive a prophylactic cerclage (prophylactic cerclage group) or not (observational group) in a proportion of 1:2. Transvaginal ultrasonographic follow-up examination of the cervix is performed in both groups. When a patient of the latter group has a cervical length <25 mm at <27 weeks' gestation, a further random assignment of therapeutic cerclage or no cerclage is performed. The analysis is by intent to treat. RESULTS:Primary random assignment allocated 23 women to the prophylactic cerclage group and 44 to the observational group. Both groups were comparable with respect to obstetric history. No significant difference was found between the prophylactic cerclage group and the observational group in preterm delivery at <34 weeks' gestation (3/23 vs 6/44, respectively) and neonatal survival (21/23 vs 41/44, respectively). A cervical length <25 mm was found in 18 patients (41%) in the observational group at a mean gestational age of 19.1 +/- 2.9 weeks' gestation. Incidence of preterm delivery at <34 weeks' gestation was significantly higher in the group with short cervical length (6/18 vs 0/26; P =.003). Secondary random assignment of the 18 patients with short cervical length allocated 10 to undergo therapeutic cerclage. Preterm delivery at <34 weeks' gestation was significantly less frequent in 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 intervention as indicated, appears to be a safe alternative to the traditional prophylactic cerclage. Transvaginal ultrasonographic follow-up examination of the cervix can save the majority of women from unnecessary intervention. Placement of a therapeutic cerclage may reduce the incidence of preterm delivery at <34 weeks' gestation among high-risk patients.

journal_name

Am J Obstet Gynecol

journal_title

American journal of obstetrics and gynecology

authors

Althuisius SM,Dekker GA,van Geijn HP,Bekedam DJ,Hummel P

doi

10.1067/mob.2000.108874

subject

Has Abstract

pub_date

2000-10-01 00:00:00

pages

823-9

issue

eissn

0002-9378

issn

1097-6868

pii

S0002-9378(00)52748-3

journal_volume

183

pub_type

临床试验,杂志文章,随机对照试验

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Cervical incompetence prevention randomized cerclage trial (CIPRACT): study design and preliminary results.