Table 3Review protocol for uterine closure techniques

Field (based on PRISMA-P)Content
Actual review questionWhat is the efficacy of single layer closure of the uterus as compared with double layer closure at caesarean birth?
Type of review questionIntervention
Objective of the reviewTo ascertain whether there are differences in efficacy between single versus two-layer closure of the uterus. Surgical technique differs between individual surgeons at present, and the existing guideline does not discuss which technique may be most appropriate.
Eligibility criteria – population/disease/condition/issue/domainWomen undergoing planned (elective) or unplanned (emergency/intrapartum) caesarean birth
  • pregnancy at or near term (≥ 34 weeks)
  • lower segment transverse uterine incision
Eligibility criteria – intervention(s)/exposure(s)/prognostic factor(s)Single layer closure of the uterus
Eligibility criteria – comparator(s)/control or reference (gold) standardDouble layer closure
Outcomes and prioritisationCritical outcomes:
  • Need for blood transfusion (within 7 days of operation)
  • Additional surgical procedures (within 7 days of operation)
  • Uterine rupture in subsequent pregnancy
Important outcomes:
  • Use of antibiotics (within 7 days of operation)
  • Morbidly adherent placenta/abnormal invasion of placenta in subsequent pregnancy
  • Peri-partum hysterectomy in subsequent pregnancy
  • Caesarean birth in subsequent pregnancy
Eligibility criteria – study design

Only published full text papers

Systematic reviews of RCTs

RCTs

Other inclusion/exclusion criteriaExclude classical incision and vertical incision
Proposed stratified, sensitivity/sub-group analysis, or meta-regression

If heterogeneity identified:

subgroup analysis for different numbers of caesarean birth (CB) (i.e. first CB versus repeat CB, need to include multiple repeat CB)

Selection process – duplicate screening/selection/analysisDuplicate screening/selection/analysis will not be undertaken for this review as this question was not prioritised for it. Included and excluded studies will be cross checked with the committee and with published systematic reviews when available.
Data management (software)

If pairwise meta-analyses are undertaken, they will be performed using Cochrane Review Manager (RevMan5).

‘GRADE’ will be used to assess the quality of evidence for each outcome.

STAR will be used for bibliographies/citations and study sifting, data extraction and quality assessment/critical appraisal.

Information sources – databases and dates

Sources to be searched: Medline, Medline In-Process, CCTR, CDSR and Embase.

Limits (e.g. date, study design): All study designs. Standard animal/non-English language filters will be applied. No date limit will be applied and no supplementary search techniques will be used.

See appendix B for full strategies.

Identify if an updateYes, this question was included in the 2011 guideline. Studies meeting the current protocol criteria and previously included in the 2011 guideline (CG132) will be included in this update.
Author contacts

Developer: National Guideline Alliance

KU.GRO.GOCR@seiriuqne-AGN

Highlight if amendment to previous protocolFor details please see section 4.5 of Developing NICE guidelines: the manual
Search strategy – for one databaseFor details please see appendix B
Data collection process – forms/duplicateA standardised evidence table format will be used, and published as appendix D (clinical evidence tables).
Data items – define all variables to be collectedFor details please see evidence tables in appendix D (clinical evidence tables).
Methods for assessing bias at outcome/study level

Appraisal of methodological quality:

The methodological quality of each study will be assessed using an appropriate checklist:

ROBIS for systematic reviews

Cochrane risk of bias tool for randomised studies

For details please see section 6.2 of Developing NICE guidelines: the manual

The risk of bias across all available evidence will evaluated for each outcome using an adaptation of the ‘Grading of Recommendations Assessment, Development and Evaluation (GRADE) toolbox’ developed by the international GRADE working group http://www​.gradeworkinggroup.org/

Criteria for quantitative synthesisFor details please see section 6.4 of Developing NICE guidelines: the manual
Methods for quantitative analysis – combining studies and exploring (in)consistency

Synthesis of data:

Meta-analysis will be conducted where appropriate using Review Manager. For detailed methods for meta-analysis, please see full guideline methods chapter.

Minimum important differences

Any significant difference will be used as the MID for the following outcomes:

  • Uterine rupture in subsequent pregnancy
  • Morbidly adherent placenta/abnormal invasion of placenta in subsequent pregnancy
  • Peri-partum hysterectomy in subsequent pregnancy

For the remaining outcomes, default values will be used of: 0.8 and 1.25 relative risk for dichotomous outcomes; 0.5 times the control group SD for continuous outcomes, unless more appropriate values are identified by the guideline committee or in the literature.

Double sifting, data extraction and methodological quality assessment:

Sifting, data extraction, appraisal of methodological quality and GRADE assessment will be performed by the systematic reviewer. Quality control will be performed by the senior systematic reviewer. Dual quality assessment and data extraction will not be performed

Meta-bias assessment – publication bias, selective reporting biasFor details please see section 6.2 of Developing NICE guidelines: the manual.
Confidence in cumulative evidenceFor details please see sections 6.4 and 9.1 of Developing NICE guidelines: the manual
Rationale/context – what is knownFor details please see the introduction to the evidence review
Describe contributions of authors and guarantor

A multidisciplinary committee developed the guideline. The committee was convened by the National Guideline Alliance and chaired by Sarah Fishburn in line with section 3 of Developing NICE guidelines: the manual.

Staff from the National Guideline Alliance undertook systematic literature searches, appraised the evidence, conducted meta-analysis and cost-effectiveness analysis where appropriate, and drafted the guideline in collaboration with the committee. For details please see the methods chapter.

Sources of funding/supportThe National Guideline Alliance is funded by NICE and hosted by the Royal College of Obstetricians and Gynaecologists
Name of sponsorThe National Guideline Alliance is funded by NICE and hosted by the Royal College of Obstetricians and Gynaecologists
Roles of sponsorNICE funds the National Guideline Alliance to develop guidelines for the NHS in England.
PROSPERO registration numberNot registered with PROSPERO

CDSR: Cochrane Database of Systematic Reviews; CENTRAL: Cochrane Central Register of Controlled Trials; DARE: Database of Abstracts of Reviews of Effects; GRADE: Grading of Recommendations Assessment, Development and Evaluation; HTA: Health Technology Assessment; NGA: National Guideline Alliance; NHS: National health service; NICE: National Institute for Health and Care Excellence; RCT: randomised controlled trial; RoB: risk of bias; SD: standard deviation

From: Techniques to close the uterus at caesarean birth

Cover of Techniques to close the uterus at caesarean birth
Techniques to close the uterus at caesarean birth: Caesarean birth: Evidence review D.
NICE Guideline, No. 192.
National Guideline Alliance (UK).
Copyright © NICE 2021.

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