Evidence map›Paper›PMID 28931404›Full record

Trial reportTrials2017

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.

N Chaillet, E Bujold, B Masse, W A Grobman, P Rozenberg, J C Pasquier, A Shorten, M Johri, F Beaudoin, H Abenhaim and 7 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact, top 84% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 8 institutions in 3 countries.

N ChailletDepartment of Obstetrics and Gynaecology, Laval University, Quebec, QC, Canada. nils.chaillet@fmed.ulaval.ca.
E BujoldDepartment of Obstetrics and Gynaecology, Laval University, Quebec, QC, Canada.
B MasseDepartment of Epidemiology and Biostatistics, University of Montréal, Montréal, QC, Canada.
W A GrobmanDepartment of Obstetrics and Gynaecology, Northwestern University, Chicago, IL, USA.
P RozenbergService de gynécologie obstétrique et médecine de la reproduction, Centre hospitalier intercommunal de Poissy/Saint-Germain-en-Laye, 10, rue du Champ-Gaillard, 78303, Poissy, France.
J C PasquierDepartment of Obstetrics and Gynecology, Sherbrooke University, Quebec, QC, Canada.
A ShortenUAB School of Nursing, University of Alabama, Birmingham, AL, USA.
M JohriUniversity of Montreal, Hospital Research Center (CRCHUM), Montreal, QC, Canada.
F BeaudoinDepartment of Obstetrics and Gynecology, University of Montreal, Montreal, QC, Canada.
H AbenhaimDepartment of Obstetrics and Gynecology, McGill University, Jewish Hospital, Montreal, QC, Canada.
S DemersDepartment of Obstetrics and Gynaecology, Laval University, Quebec, QC, Canada.
W FraserDepartment of Obstetrics and Gynecology, Sherbrooke University, Quebec, QC, Canada.
M DugasPopulation Health and Optimal Health Practices Research Unit, CHU de Québec Research Centre, Quebec, QC, Canada.
S BlouinDepartment of Obstetrics and Gynaecology, Laval University, Quebec, QC, Canada.
E DubéDepartment of Obstetrics and Gynaecology, Laval University, Quebec, QC, Canada.
R GauthierDepartment of Obstetrics and Gynecology, University of Montreal, Montreal, QC, Canada.
PRISMA Trial Research Group
Université Laval · CAUniversité de Montréal · CAUniversité de Sherbrooke · CACentre Hospitalier Intercommunal de Poissy · FRMcGill University · CANorthwestern University · USQuebec Research and Development CentreUniversity of Alabama at Birmingham · US

Funding

CIHR MOP-142448
6 · The paper itself

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. DISCUSSION: 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.

trial registrationCurrent Controlled Trials, ID: ISRCTN15346559 . Registered on 20 August 2015.

Indexed as

Cesarean Section, RepeatDecision Support TechniquesMaternal HealthPregnancy OutcomeVaginal Birth after CesareanChoice BehaviorClinical Decision-MakingClinical ProtocolsCost-Benefit AnalysisFemaleHealth Care CostsHumansLogistic ModelsMultivariate AnalysisNomogramsPatient ParticipationIntrapartum managementRCTUterine ruptureVBAC

Identifiers

PMID28931404
PMCPMC5608183
OpenAlexW2754609856

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.