Chaillet N, Bujold E, Masse B, Grobman W A, Rozenberg P, Pasquier J C, Shorten A, Johri M, Beaudoin F, Abenhaim H, Demers S, Fraser W, Dugas M, Blouin S, Dubé E, Gauthier R
Department of Obstetrics and Gynaecology, Laval University, Quebec, QC, Canada.
Faculté de Médecine, Département d'Obstétrique & Gynécologie, Université Laval, Centre de recherche du CHUQ, 2705, Boul. Laurier, local T-R-92, Quebec, QC, G1V 4G2, Canada.
Trials. 2017 Sep 20;18(1):434. doi: 10.1186/s13063-017-2150-x.
Rates of cesarean delivery are continuously increasing in industrialized countries, with repeated cesarean accounting for about a third of all cesareans. Women who have undergone a first cesarean are facing a difficult choice for their next pregnancy, i.e.: (1) to plan for a second cesarean delivery, associated with higher risk of maternal complications than vaginal delivery; or (b) to have a trial of labor (TOL) with the aim to achieve a vaginal birth after cesarean (VBAC) and to accept a significant, but rare, risk of uterine rupture and its related maternal and neonatal complications. The objective of this trial is to assess whether a multifaceted intervention would reduce the rate of major perinatal morbidity among women with one prior cesarean.
METHODS/DESIGN: The study is a stratified, non-blinded, cluster-randomized, parallel-group trial of a multifaceted intervention. Hospitals in Quebec are the units of randomization and women are the units of analysis. As depicted in Figure 1, the study includes a 1-year pre-intervention period (baseline), a 5-month implementation period, and a 2-year intervention period. At the end of the baseline period, 20 hospitals will be allocated to the intervention group and 20 to the control group, using a randomization stratified by level of care. Medical records will be used to collect data before and during the intervention period. Primary outcome is the rate of a composite of major perinatal morbidities measured during the intervention period. Secondary outcomes include major and minor maternal morbidity; minor perinatal morbidity; and TOL and VBAC rate. The effect of the intervention will be assessed using the multivariable generalized-estimating-equations extension of logistic regression. The evaluation will include subgroup analyses for preterm and term birth, and a cost-effectiveness analysis.
The intervention is designed to facilitate: (1) women's decision-making process, using a decision analysis tool (DAT), (2) an estimate of uterine rupture risk during TOL using ultrasound evaluation of low-uterine segment thickness, (3) an estimate of chance of TOL success, using a validated prediction tool, and (4) the implementation of best practices for intrapartum management.
Current Controlled Trials, ID: ISRCTN15346559 . Registered on 20 August 2015.
在工业化国家，剖宫产率持续上升，其中再次剖宫产约占所有剖宫产的三分之一。接受过首次剖宫产的女性在下次怀孕时面临艰难抉择，即：（1）计划进行第二次剖宫产，这与比阴道分娩更高的母体并发症风险相关；或（2）进行引产试验（TOL），旨在实现剖宫产后阴道分娩（VBAC），并接受子宫破裂及其相关母体和新生儿并发症的显著但罕见的风险。本试验的目的是评估多方面干预措施是否会降低有过一次剖宫产史的女性的主要围产期发病率。
方法/设计：本研究是一项多方面干预措施的分层、非盲、整群随机、平行组试验。魁北克的医院是随机分组单位，女性是分析单位。如图1所示，研究包括1年的干预前期（基线期）、5个月的实施期和2年的干预期。在基线期结束时，将根据护理级别分层随机分配20家医院至干预组，20家医院至对照组。干预期间将使用医疗记录收集数据。主要结局是干预期内测量的主要围产期发病率的综合发生率。次要结局包括主要和次要母体发病率；次要围产期发病率；以及引产试验和剖宫产后阴道分娩率。将使用逻辑回归的多变量广义估计方程扩展来评估干预效果。评估将包括早产和足月产的亚组分析以及成本效益分析。
该干预措施旨在促进：（1）使用决策分析工具（DAT）辅助女性的决策过程；（2）通过超声评估子宫下段厚度来估计引产试验期间子宫破裂的风险；（3）使用经过验证的预测工具估计引产试验成功的几率；以及（4）实施产时管理的最佳实践。
当前受控试验，编号：ISRCTN15346559。于2015年8月20日注册。
