Althuisius S M, Dekker G A, van Geijn H P, Bekedam D J, Hummel P
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University Hospital Vrije Universiteit, Amsterdam, The Netherlands.
Am J Obstet Gynecol. 2000 Oct;183(4):823-9. doi: 10.1067/mob.2000.108874.
The objective of this study was to compare different management strategies for women at risk for cervical incompetence.
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.
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).
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.
本研究的目的是比较宫颈机能不全风险女性的不同管理策略。
在一项正在进行的随机试验中，既往有孕34周前早产且符合宫颈机能不全临床诊断标准的患者，按1:2的比例分配接受预防性宫颈环扎术（预防性宫颈环扎组）或不接受（观察组）。两组均进行经阴道超声宫颈随访检查。当观察组患者在孕27周前宫颈长度<25mm时，进一步随机分配进行治疗性宫颈环扎或不进行宫颈环扎。分析采用意向性分析。
初次随机分配将23名女性分配至预防性宫颈环扎组，44名分配至观察组。两组在产科病史方面具有可比性。预防性宫颈环扎组与观察组在孕34周前早产（分别为3/23和6/44）及新生儿存活率（分别为21/23和41/44）方面未发现显著差异。观察组18例患者（41%）在平均孕周19.1±2.9周时宫颈长度<25mm。宫颈长度短的组孕34周前早产发生率显著更高（6/18 vs 0/26；P = 0.003）。对18例宫颈长度短的患者进行二次随机分配，其中10例接受治疗性宫颈环扎。治疗性宫颈环扎组孕34周前早产的发生率显著更低（1/10 vs 5/8）。
对于有宫颈机能不全风险的女性，经阴道超声对宫颈进行系列随访检查，并根据情况进行二次干预，似乎是传统预防性宫颈环扎术的一种安全替代方法。经阴道超声宫颈随访检查可使大多数女性避免不必要的干预。放置治疗性宫颈环扎术可能会降低高危患者孕34周前早产的发生率。
