Abstract
BackgroundRates 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/designThe 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.DiscussionThe 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.Trial registrationCurrent Controlled Trials, ID: ISRCTN15346559. Registered on 20 August 2015.
Highlights
Rates of cesarean delivery are continuously increasing in industrialized countries, with repeated cesarean accounting for about a third of all cesareans
Over 30,000 women in Canada who have undergone a cesarean delivery will be faced with a difficult choice for their pregnancy, i.e.: (1) plan for a second cesarean delivery, associated with a higher risk of maternal complications than a vaginal delivery [4, 5], or (2) have a trial of labor (TOL) to achieve a vaginal birth after cesarean (VBAC) and accept a significant, but rare, risk of uterine rupture [6,7,8,9], which constitutes a principal complication related to a TOL [10,11,12,13,14,15,16]
Findings indicated: (1) the combination of abdominal and endovaginal ultrasounds allowed an optimal detection rate for uterine scar defect; [50, 51], (2) a lower uterine segment (LUS) thickness < 2.0 mm represent a higher risk of uterine rupture (>1%), a LUS thickness ≥ 2.0 and < 2.5 mm represent a moderate risk of uterine rupture, and a LUS thickness ≥ 2.5 mm represent a low risk of uterine rupture (
Summary
The PRISMA trial is a phase III cluster randomized controlled trial to assess the effectiveness of a multifaceted intervention aiming to reduce severe perinatal morbidity in women with one previous cesarean delivery. An important challenge relies in the implementation of the program, which may differ in different hospitals In this Trial, a high level of implementation will be ensured by the support of local partners and healthcare professionals identified in intervention hospitals, by continuous internal assessments for compliance, by an annual site monitoring visit or more if required, and by a centralized platform in Québec allowing an external validation of each LUS thickness measures. This real time validation will ensure a constant follow up with participating physicians.
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