Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA (Drs Gulersen and Berghella).
Biostatistics and Data Management, New York University Rory Meyers College of Nursing, New York, NY (Dr Lenchner).
Am J Obstet Gynecol MFM. 2023 Jun;5(6):100930. doi: 10.1016/j.ajogmf.2023.100930. Epub 2023 Mar 15.
This study aimed to determine whether cervical cerclage for a transvaginal ultrasound-detected short cervical length after 24 weeks of gestation in singleton pregnancies reduces the risk for preterm birth.
Ovid MEDLINE, Scopus, and the Cochrane Central Register of Controlled Trials were searched using the following terms: "cerclage, cervical," "uterine cervical incompetence," "obstetrical surgical procedures," "cervix uteri," "randomized controlled trial," and "controlled clinical trial."
All randomized controlled trials comparing cerclage placement with no cerclage in singleton gestations with a transvaginal ultrasound-detected short cervical length ≤25 mm between 24+0/7 and 29+6/7 weeks of gestation were eligible for inclusion.
Individual patient-level data from each trial were collected. If an eligible trial included patients with both multiple and singleton gestations with a short cervical length detected either before or after 24+0/7 weeks of gestation, only singletons who presented at or after 24+0/7 weeks were included. The primary outcome was preterm birth <37 weeks' gestation. Secondary outcomes included preterm birth <34, <32, and <28 weeks' gestation, gestational age at delivery, latency, preterm prelabor rupture of membranes, chorioamnionitis, and adverse neonatal outcomes. Individual patient-level data from each trial were analyzed using a 2-stage approach. Pooled relative risks or mean differences with 95% confidence intervals were calculated as appropriate.
Data from the 4 eligible randomized controlled trials were included. A total of 131 singletons presented at 24+0/7 to 26+6/7 weeks of gestation and were further analyzed; there were no data on patients with a cerclage at 27+0/7 weeks' gestation or later. Of those included, 66 (50.4%) were in the cerclage group and 65 (49.6%) were in the no cerclage group. The rate of preterm birth <37 weeks' gestation was similar between patients who were randomized to the cerclage group and those who were randomized to the no cerclage group (27.3% vs 38.5%; relative risk, 0.78; 95% confidence interval, 0.37-1.28). Secondary outcomes including preterm birth <34, <32, and <28 weeks' gestation, gestational age at delivery, time interval from randomization to delivery, preterm prelabor rupture of membranes, and adverse neonatal outcomes such as low birthweight, very low birthweight, and perinatal death were similar between the 2 groups. Planned subgroup analyses revealed no statistically significant differences in the rate of preterm birth <37 weeks' gestation between the 2 groups when compared based on cervical length measurement (≤15 mm or ≤10 mm), gestational age at randomization (24+0/7 to 24+6/7 weeks or 25+0/7 to 26+6/7 weeks), or history of preterm birth.
Cervical cerclage did not reduce or increase the rate of preterm birth among singleton pregnancies with a short cervical length detected after 24 weeks of gestation. Because there was a 22% nonsignificant decrease in preterm birth associated with cerclage, which is a similar amount of risk reduction often associated with ultrasound-indicated cerclage before 24 weeks' gestation, further randomized controlled trials in this patient population are warranted.
本研究旨在确定经阴道超声检测到妊娠 24 周后宫颈长度较短的单胎妊娠中,行宫颈环扎术是否能降低早产风险。
使用以下术语在 Ovid MEDLINE、Scopus 和 Cochrane 对照试验中心注册库中进行了检索:“cerclage,cervical”、“uterine cervical incompetence”、“obstetrical surgical procedures”、“cervix uteri”、“randomized controlled trial”和“controlled clinical trial”。
所有比较经阴道超声检测到的 24+0/7 至 29+6/7 周妊娠的单胎妊娠中宫颈长度≤25mm 的短宫颈长度的环扎术与无环扎术的随机对照试验均符合纳入标准。
从每个试验中收集个体患者水平数据。如果符合条件的试验包括经阴道超声检测到的短宫颈长度在 24+0/7 周之前或之后的多胎和单胎妊娠患者,则仅纳入在 24+0/7 周或之后出现的单胎妊娠。主要结局是 37 周前早产。次要结局包括早产<34 周、<32 周和<28 周、分娩时的胎龄、潜伏期、早产胎膜早破、绒毛膜羊膜炎和不良新生儿结局。每个试验的个体患者水平数据采用两阶段方法进行分析。适当计算了合并相对风险或均数差值及其 95%置信区间。
纳入了 4 项符合条件的随机对照试验的数据。进一步分析了 131 名在 24+0/7 至 26+6/7 周妊娠时出现的单胎妊娠患者;没有 27+0/7 周或更晚行环扎术的患者数据。其中,66 例(50.4%)接受环扎术,65 例(49.6%)接受无环扎术。随机分配至环扎组和无环扎组的患者早产<37 周的发生率相似(27.3%vs.38.5%;相对风险,0.78;95%置信区间,0.37-1.28)。次要结局包括早产<34 周、<32 周和<28 周、分娩时的胎龄、从随机分组到分娩的时间间隔、早产胎膜早破以及低出生体重、极低出生体重和围产期死亡等不良新生儿结局在两组间相似。计划的亚组分析显示,基于宫颈长度测量(≤15mm 或≤10mm)、随机分组时的胎龄(24+0/7 至 24+6/7 周或 25+0/7 至 26+6/7 周)或早产史,两组间 37 周前早产的发生率无统计学显著差异。
在妊娠 24 周后经阴道超声检测到宫颈长度较短的单胎妊娠中,行宫颈环扎术并不能降低或增加早产率。由于环扎术与早产率降低 22%相关,这与通常与妊娠 24 周前超声指示性环扎相关的风险降低量相似,因此有必要在该患者人群中进行进一步的随机对照试验。