Evidence map›Paper›PMID 28188151›Full record

Trial reportBMJ open2017

Perineal resuturing versus expectant management following vaginal delivery complicated by a dehisced wound (PREVIEW): a pilot and feasibility randomised controlled trial.

L Dudley, C Kettle, P W Thomas, K M K Ismail

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

Trial report in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 13 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 3 pooled it
3.1field-weighted citation impact, top 9% 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

13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 39 citations in OpenAlex.

  1. Pooled it
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  3. Antibiotic prophylaxis for operative vaginal delivery.The Cochrane database of systematic reviews · 2020
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors at 4 institutions in 1 country.

L DudleyThe Maternity Centre, Royal Stoke, University Hospitals of North Midlands, Staffordshire, UK.
C KettleFaculty of Health Sciences, Professor Emerita of Women's Health, Staffordshire University, Stafford, UK.
P W ThomasFaculty of Health and Social Sciences, Professor of Health Care Statistics and Epidemiology, Bournemouth University Clinical Research Unit, Bournemouth University, Dorset, UK.
K M K IsmailInstitute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
Bournemouth University · GBRoyal Stoke University Hospital · GBUniversity of Birmingham · GBUniversity of Staffordshire · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo establish the feasibility of conducting a definitive randomised controlled trial (RCT) comparing the effectiveness of resuturing versus expectant management for dehisced perineal wounds.

designA multicentre pilot and feasibility RCT.

settingTen UK maternity units from July 2011 to July 2013. POPULATION: Eligible women with a dehisced perineal wound within 2 weeks of childbirth.

methodsThe interventions were resuturing or expectancy. Randomisation was via web or telephone, stratified by participating centre. Blinding was not possible due to the nature of the interventions. Analysis was by intention-to-treat. OUTCOME: The primary outcome measure was wound healing at 6-8 weeks.

resultsThe study revealed a number of feasibility issues, particularly strong patient and clinician preference for treatment options at recruiting centres and the timing of the primary outcome measure. Thirty-four women were randomised (17 in each arm). Data from 33 women were analysed on an intention-to-treat analysis to obtain preliminary estimates of effect size. There was a difference in wound healing at 2 weeks favouring resuturing (OR 20.00, 95% CI 2.04 to 196.37, p=0.004). However, by 6-8 weeks all but one wound in both groups had healed.

conclusionsPREVIEW revealed a number of feasibility issues, which impacted on recruitment rate. These will have to be taken into account in the design of any future definitive study. In this feasibility study, resuturing was associated with quicker wound healing and women reported higher satisfaction rates with the outcome at 3 months. TRIAL REGISTRATION NUMBER: ISRCTN05754020.

Indexed as

Conservative TreatmentDelivery, ObstetricSuture TechniquesAdultFeasibility StudiesFemaleHumansLacerationsPatient SatisfactionPerineumPilot ProjectsPregnancySurgical Wound DehiscenceTreatment OutcomeUnited KingdomWound HealingDehiscenceExpectancyPerineumPostnatalRe-suturing

Identifiers

PMID28188151
PMCPMC5306527
OpenAlexW2586236334

What OpenQuestion holds

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Registered trials

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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.