Cervical cerclage for prevention of preterm delivery in women with short cervix: randomised controlled trial
Cervical cerclage for prevention of preterm delivery in women with short cervix: randomised controlled trial
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DOI：
10.1016/s0140-6736(04)16351-4
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发表时间：
2004-06-05
期刊：
影响因子：
168.9
通讯作者：
Nicolaides, KH
中科院分区：
文献类型：
--
作者：
To, MS;Alfirevic, Z;Nicolaides, KH
背景 过去 50 年来，宫颈环扎术已广泛用于预防早期早产及其相关的新生儿死亡率和发病率。随机试验的结果总体上并未支持这种做法，但缺乏益处可能是由于患者选择不理想，而患者选择基本上是基于产科病史。识别早期早产高危人群的更有效方法可能是通过阴道超声测量宫颈长度。我们进行了一项多中心随机对照试验，以调查在妊娠 22-24 周时通过常规经阴道扫描发现宫颈较短的女性中，插入 Shirodkar 缝合线是否会减少早期早产。方法 对 47 123 名女性进行了宫颈长度测量。 470 名女性的子宫颈直径为 15 毫米或以下，其中 253 名 (54%) 女性参与了这项研究，并被随机分配接受宫颈环扎术 (127 例) 或期待治疗 (126 例)。主要结局是怀孕 33 周（231 天）前的分娩频率。结果 两组中 33 周前早产的比例相似，环扎组为 22%（127 人中的 28 人），而对照组为 26%（126 人中的 33 人）（相对风险=0.84，95% Cl 0.54-1.31，p=0.44），无显着性差异。围产期或孕产妇发病率或死亡率的差异。解释 对于子宫颈短的女性插入 Shirodkar 缝线并不能显着降低早期早产的风险。 22-24 周时常规超声测量宫颈长度可识别早期早产高风险人群。
Background Cervical cerclage has been widely used in the past 50 years to prevent early preterm birth and its associated neonatal mortality and morbidity. Results of randomised trials have not generally lent support to this practice, but this absence of benefit may be due to suboptimum patient selection, which was essentially based on obstetric history. A more effective way of identifying the high-risk group for early preterm delivery might be by transvaginal sonographic measurement of cervical length. We undertook a multicentre randomised controlled trial to investigate whether, in women with a short cervix identified by routine transvaginal scanning at 22-24 weeks' gestation, the insertion of a Shirodkar suture reduces early preterm delivery.Methods Cervical length was measured in 47 123 women. The cervix was 15 mm or less in 470, and 253 (54%) of these women participated in the study and were randomised to cervical cerclage (127) or to expectant management (126). Primary outcome was the frequency of delivery before 33 completed weeks (231 days) of pregnancy.Findings The proportion of preterm delivery before 33 weeks was similar in both groups, 22% (28 of 127) in the cerclage group versus 26% (33 of 126) in the control group (relative risk=0.84, 95% Cl 0.54-1.31, p=0.44), with no significant differences in perinatal or maternal morbidity or mortality.Interpretation The insertion of a Shirodkar suture in women with a short cervix does not substantially reduce the risk of early preterm delivery. Routine sonographic measurement of cervical length at 22-24 weeks identifies a group at high risk of early preterm birth.