Messinger Chelsea J, Hernández-Díaz Sonia, Hofman Albert, Sadlak Natalie, Einarsson Jon, McElrath Thomas F
Department of Anesthesiology, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, MA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA; Harvard Medical School, Boston, MA.
Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA.
Am J Obstet Gynecol. 2025 Jul 9. doi: 10.1016/j.ajog.2025.06.049.
The 2020 Multicentre Abdominal vs Vaginal Randomised Intervention of Cerclage trial found that transabdominal cerclage placed via open laparotomy reduces the risk of spontaneous preterm birth before 32 weeks relative to transvaginal cerclage in a very high-risk obstetric population. It is not known whether the results of the trial generalize to obstetric populations with fewer risk factors, on average, for recurrent spontaneous preterm birth, or to patients without history of failed transvaginal cerclage (an inclusion criterium in the trial).
We identified a cohort of adult singleton pregnancies who received history-indicated cerclage at a quaternary care center in the United States. The cohort consisted of patients with a history of ≥1 spontaneous deliveries (birth or fetal loss) <28 weeks and patients with a history of failed transvaginal cerclage, defined as ≥1 spontaneous preterm deliveries <34 weeks with cervical cerclage in situ. All eligible patients who received transabdominal cerclage were compared to a sample of eligible patients who received transvaginal cerclage. We performed survival analysis with inverse probability weights to adjust for potential sources of bias. Effects were estimated as risk difference, risk ratio, and 95% confidence intervals. Subgroup analyses were performed among patients without a history of failed transvaginal cerclage. The risks of surgical, delivery, and neonatal outcomes were described.
One hundred eighty-eight patients were included, of whom 87 received transabdominal cerclage (99% laparoscopic) and 101 received transvaginal cerclage. Twenty-six patients (30%) with transabdominal cerclage had no history of failed transvaginal cerclage, the majority of whom had additional clinical reasons why transabdominal cerclage was offered. After adjusting for confounding, the adjusted risk of early preterm delivery was 5.5% in the transabdominal group (95% confidence interval, 2.0%, 9.4%) and 18.7% in the transvaginal group (95% confidence interval, 6.8%, 31.4%), risk difference = -13.1% (95% confidence interval, -26.6%, -0.5%), and risk ratio = 0.30 (95% confidence interval, 0.10, 0.94). Among patients without history of failed transvaginal cerclage (N = 104 total, N = 26 in transabdominal group), the risk difference was -12.6% (-21.6%, -4.1%). Risks of placement and delivery complications were comparable across groups but included a few serious uterine complications in the transabdominal cerclage group. Neonatal intensive care unit admission occurred in 35% and 23% of neonates in the transabdominal and transvaginal groups, respectively.
Among women with history of ≥1 preterm deliveries <28 weeks or failed transvaginal cerclage <34 weeks, transabdominal cerclage reduced the risk of preterm delivery <34 weeks compared to transvaginal cerclage, consistent with the Multicentre Abdominal vs Vaginal Randomised Intervention of Cerclage trial findings. Conclusions about efficacy among patients without history of failed transvaginal cerclage are limited by small sample size. Further research is necessary to understand whether the benefits of transabdominal cerclage in subgroups of patients outweigh risks of abdominal surgery and cesarean delivery.
2020年多中心经腹与经阴道宫颈环扎随机干预试验发现，在高危产科人群中，经腹开放性剖腹手术进行宫颈环扎相对于经阴道宫颈环扎可降低32周前自发早产的风险。尚不清楚该试验结果是否适用于平均复发性自发早产风险因素较少的产科人群，或适用于无经阴道宫颈环扎失败史（该试验的纳入标准）的患者。
1）评估在四级医疗中心有宫颈机能不全病史的患者中，经腹宫颈环扎与经阴道宫颈环扎对早期早产（<34周）的影响；2）评估在无经阴道宫颈环扎失败史的患者亚组中的影响；3）描述放置和分娩相关并发症及新生儿结局。
我们在美国一家四级医疗中心确定了一组接受根据病史进行宫颈环扎的成年单胎妊娠队列。该队列包括有≥1次<28周自发分娩（活产或胎儿丢失）病史的患者以及有经阴道宫颈环扎失败史的患者，经阴道宫颈环扎失败定义为≥1次<34周自发早产且宫颈环扎在位。将所有接受经腹宫颈环扎的符合条件患者与接受经阴道宫颈环扎的符合条件患者样本进行比较。我们采用逆概率加权法进行生存分析以调整潜在的偏倚来源。效应估计为风险差、风险比和95%置信区间。在无经阴道宫颈环扎失败史的患者中进行亚组分析。描述手术、分娩和新生儿结局的风险。
共纳入188例患者，其中87例接受经腹宫颈环扎（99%为腹腔镜手术），101例接受经阴道宫颈环扎。26例（30%）接受经腹宫颈环扎的患者无经阴道宫颈环扎失败史，其中大多数有其他临床原因而选择经腹宫颈环扎。在调整混杂因素后经腹组早期早产的校正风险为5.5%（95%置信区间，2.0%，9.4%），经阴道组为18.7%（95%置信区间，6.8%，31.4%），风险差=-13.1%（95%置信区间，-26.6%，-0.5%），风险比=0.30（95%置信区间，0.10，0.94）。在无经阴道宫颈环扎失败史的患者中（共104例，经腹组26例），风险差为-12.6%（-21.6%，-4.1%）。两组放置和分娩并发症的风险相当，但经腹宫颈环扎组包括一些严重的子宫并发症。经腹组和经阴道组分别有35%和23%的新生儿入住新生儿重症监护病房。
在有≥1次<28周早产史或<34周经阴道宫颈环扎失败史的女性中，与经阴道宫颈环扎相比，经腹宫颈环扎降低了<34周早产的风险，这与多中心经腹与经阴道宫颈环扎随机干预试验的结果一致。关于无经阴道宫颈环扎失败史患者疗效的结论因样本量小而受限。有必要进一步研究以了解经腹宫颈环扎在患者亚组中的益处是否超过腹部手术和剖宫产的风险。
