A cluster-randomized trial to reduce major perinatal morbidity among women with one prior cesarean delivery in Québec (PRISMA trial): study protocol for a randomized controlled trial.
A cluster-randomized trial to reduce major perinatal morbidity among women with one prior cesarean delivery in Québec (PRISMA trial): study protocol for a randomized controlled trial.
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DOI：
10.1186/s13063-017-2150-x
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发表时间：
2017-09-20
期刊：
影响因子：
2.5
通讯作者：
PRISMA Trial Research Group
中科院分区：
文献类型：
--
作者：
Chaillet N;Bujold E;Masse B;Grobman WA;Rozenberg P;Pasquier JC;Shorten A;Johri M;Beaudoin F;Abenhaim H;Demers S;Fraser W;Dugas M;Blouin S;Dubé E;Gauthier R;PRISMA Trial Research Group
在工业化国家，剖腹产率持续上升，重复剖腹产约占所有剖腹产的三分之一。第一次剖腹产的妇女面临着下一次怀孕的艰难选择，即：(1)计划第二次剖腹产，与阴道分娩相比，产妇并发症的风险更高;或（B）进行试产（TOL），目的是实现剖腹产后阴道分娩（VBAC），并接受子宫破裂及其相关产妇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的干预是否会降低一次剖宫产妇女围产期主要发病率。该研究是一项多方面干预的分层、非盲、随机分组、平行组试验。魁北克的医院是随机分组单位，妇女是分析单位。如图1所示，该研究包括1年的干预前阶段（基线）、5个月的实施阶段和2年的干预阶段。在基线期结束时，将20家医院分配到干预组，20家医院分配到对照组，使用按护理水平分层的随机化。医疗记录将用于收集干预前和干预期间的数据。主要结局是在干预期间测量的主要围产期发病率的复合发生率。次要结局包括主要和次要孕产妇发病率;次要围产期发病率; TOL和VBAC率。将使用logistic回归的多变量广义估计方程扩展来评估干预的效果。评估将包括早产和足月分娩的亚组分析以及成本效益分析。该干预措施旨在促进：（1）妇女的决策过程，使用决策分析工具（DAT），（2）使用超声评估子宫低段厚度来估计TOL期间子宫破裂的风险，（3）使用经验证的预测工具来估计TOL成功的机会，以及（4）实施产时管理的最佳实践。当前对照试验，ID：ISRCTN 15346559。于2015年8月20日注册。本文的在线版本（doi：10.1186/s13063-017-2150-x）包含补充材料，可供授权用户使用。
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. 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. The online version of this article (doi:10.1186/s13063-017-2150-x) contains supplementary material, which is available to authorized users.
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影响因子：
168.9
作者：
Dumont, Alexandre;Fournier, Pierre;Fraser, William D.
通讯作者：
Fraser, William D.
DOI：
10.1016/s1701-2163(16)34478-4
发表时间：
2010-04-01
影响因子：
1.8
作者：
Bujold, Emmanuel;Jastrow, Nicole;Chaillet, Nils
通讯作者：
Chaillet, Nils
影响因子：
7.2
作者：
Costantine, Maged M.;Fox, Karin;Saade, George
通讯作者：
Saade, George
影响因子：
3.6
作者：
Briggs, Andrew H.;Weinstein, Milton C.;Paltiel, A. David
通讯作者：
Paltiel, A. David
影响因子：
9.8
作者：
Bergeron, Marie-Eve;Beaudet, Christine;Laberge, Philippe
通讯作者：
Laberge, Philippe