Final results of the Cervical Incompetence Prevention Randomized Cerclage Trial (CIPRACT): Therapeutic cerclage with bed rest versus bed rest alone
Final results of the Cervical Incompetence Prevention Randomized Cerclage Trial (CIPRACT): Therapeutic cerclage with bed rest versus bed rest alone
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DOI：
10.1067/mob.2001.118655
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发表时间：
2001-11-01
影响因子：
9.8
通讯作者：
van Geijn, HP
中科院分区：
文献类型：
--
作者：
Althuisius, SM;Dekker, GA;van Geijn, HP
目的：比较早产率（前34周妊娠）和新生儿的发病率和死亡率的危险因素或症状的宫颈机能不全的患者管理与治疗麦当劳环扎术和卧床休息与bed rest onesel.Study设计：宫颈长度测量宫颈机能不全的危险因素或症状的患者。宫颈机能不全的危险因素包括妊娠34周之前的早产，符合宫颈机能不全的临床诊断标准，妊娠32周之前的胎膜早破，冷刀锥切术史，己烯雌酚暴露和子宫异常。当在胎龄27周之前测量宫颈长度< 25 mm时，进行治疗性环扎和卧床休息（环扎组）或单独卧床休息（卧床休息组）的随机分组。分析是基于意向treat.Results：35名妇女谁符合纳入标准，19人被随机分配到环扎组和16卧床休息组。两组在随机化时的平均宫颈长度和平均胎龄相当，平均总体20 mm和21周。34周前早产在卧床休息组中的发生率明显高于环扎组（分别为7/16 vs 0; P = 0.002）。两组新生儿存活率无统计学显著差异（卧床休息组13例新生儿存活，环扎组全部存活）。新生儿复合发病率，定义为新生儿重症监护室入院或新生儿死亡，在卧床休息组明显高于环扎组（16例中8例vs 19例中1例; P = 0.005; RR = 9.5，95% CI，1.3-68.1）。治疗性宫颈环扎术联合卧床休息可减少妊娠34周前的早产，并减少妊娠27周前有宫颈机能不全危险因素和/或症状且宫颈长度< 25 mm的妇女的新生儿并发症发病率。
OBJECTIVE: To compare preterm delivery rates (before 34 weeks of gestation) and neonatal morbidity and mortality in patients with risk factors or symptoms of cervical incompetence managed with therapeutic McDonald cerclage and 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 clinical criteria for the diagnosis of cervical incompetence, previous preterm premature rupture of membranes before 32 weeks of gestation, history of cold knife conization, diethylstilbestrol exposure, and uterine anomaly. When a cervical length of < 25 mm was measured before a gestational age of 27 weeks, a randomization for therapeutic cerclage and bed rest (cerclage group) 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 were 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 cerclage group (7 of 16 vs none, respectively; P = .002). There was no statistically significant difference in neonatal survival between the groups (13 neonates survived in the bed rest group vs all in the cerclage group). The compound 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 before 34 weeks of gestation and compound neonatal morbidity in women with risk factors and/or symptoms of cervical incompetence and a cervical length of < 25 mm before 27 weeks of gestation.