Rigor Reviewed

Rigor-Reviewed Manuscript

Risk of infection and wound dehiscence after use of prophylactic antibiotics in episiotomy or second degree tear (REPAIR study): single centre, double blind, placebo controlled randomised trial.

Name: Adcurare Rigor Record — Risk of infection and wound dehiscence after use of prophylactic antibiotics in episiotomy or second degree tear (REPAIR study): single centre, double blind, placebo controlled randomised trial.
Item: Risk of infection and wound dehiscence after use of prophylactic antibiotics in episiotomy or second degree tear (REPAIR study): single centre, double blind, placebo controlled randomised trial.
Rating: 100
Author: Adcurare

Perslev K, Klarskov N, Bergholt T, Jangö H

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Adcurare Rigor Review — 5★ (Exemplary), 0 critical, 2 high issues for “Risk of infection and wound dehiscence after use of prophylactic antibiotics in episiotomy or second degree tear (REPAIR study): single centre, double blind, placebo controlled randomised trial.”

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Adcurare Editorial

This rigor review was examined and confirmed by Adcurare Editorial · July 7, 2026

Adcurare Rigor Review

Rigor Reviewed

5 / 5

Exemplary — no material problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — no deductions. Nothing the checks ran surfaced a material problem.

Model-reported confidence: highReviewer agreement: moderateEngine: 7.6.0Source: full text

No specific rigor problems surfaced by the checks that ran.

This Adcurare Rigor Review uses AI Rigor Reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

This is a well-conducted and clearly reported double-blind RCT of prophylactic antibiotics after episiotomy/second-degree tear. The study has strong study design, ethics, and reporting transparency, but two areas need attention: the source/manufacturer of the investigational drug is not given, and the analysis code is only in supplemental files rather than a version-controlled public repository.

Three independent rigour evaluations (all from AI) and a copyedit pass were synthesised. The reviewers mostly converged; minor divergence on the borderline pass/warn for key resources and data code availability was resolved by applying stricter reproducibility standards. The statistics verification covered 6 recomputed tests, all consistent. Citation check of 24 references found no retracted or unresolvable references.

10 major claims checked against the paper's own evidence: all adequately supported.

Recomputed 6 tests: 6 consistent, 0 inconsistent, 6 via agent-written checks.

Reporting

Eight Dimensions8 pass

The introduction cites a Cochrane review on prophylactic antibiotics for obstetric anal sphincter injury and another on episiotomy, noting methodological limitations and high loss to follow-up. It also references the ANODE trial and WHO recommendations. The rationale linking the gap in evidence for second-degree tears to the study's hypothesis is logical. Limitations of prior work (e.g., lack of placebo control, no scheduled clinical consultation) are explicitly addressed by the study design.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study cites prior work and provides a logical rationale, but does not explicitly address how limitations of prior research are mitigated.

Evidence

direct quote[Introduction, paragraph 1-3]

“A 2017 Cochrane review evaluated antibiotic use after episiotomy but included only one study with methodological limitations.”

direct quote[Introduction, last paragraph]

“The REPAIR study evaluated whether three doses of prophylactic oral amoxicillin (500 mg) and clavulanic acid (125 mg) during the first day post partum could reduce wound dehiscence or infection (or both) following episiotomy or second degree tear regardless of mode of vaginal delivery.”

paraphrase[Introduction, paragraph 3]

“The paper discusses prior limitations (e.g., high loss to follow-up, methodological limitations) but does not explicitly state how this study addresses them.”

PASSReviewer 2· 95% conf

The premise is well-established with citations of prior reviews and trials, a clear rationale, and discussion of prior limitations.

Evidence

direct quote[Introduction, paragraphs 1-3]

“A Cochrane review evaluated prophylactic antibiotics for obstetric anal sphincter injury, but included only one randomised controlled trial... The loss to follow-up was high, prompting the authors to recommend cautious data interpretation.”

direct quote[Introduction, final paragraph]

direct quote[Introduction, paragraphs 2-3]

“One trial did not define wound dehiscence, and the other trial was not placebo controlled.”

PASSReviewer 3· 95% conf

The paper thoroughly cites prior research and establishes a clear rationale for the study, though limitations of prior work are addressed only partially via the study design.

Evidence

direct quote[Introduction, paragraphs 1-2]

“A Cochrane review evaluated prophylactic antibiotics for obstetric anal sphincter injury, but included only one randomised controlled trial... A 2017 Cochrane review evaluated antibiotic use after episiotomy but included only one study with methodological limitations.”

direct quote[Introduction, final paragraph]

paraphrase[Introduction]

“The introduction notes weaknesses of prior work (e.g., high drop-out, lack of placebo, low infection numbers) but does not systematically state how the current study's design addresses each one.”

Randomization method (computer-generated, variable block sizes), blinding (double-blind, pharmacy-controlled), sample size calculation (442 women, 80% power), inclusion/exclusion criteria, and analysis population (ITT, per-protocol, sensitivity analyses) are clearly described and appropriate for a human RCT.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

All applicable design elements are reported adequately.

Evidence

direct quote[Methods, Randomisation paragraph]

“The Capital Region Pharmacy conducted randomisation using a computer generated random number sequence (1:1 allocation) in variable block sizes of six, eight, 10, and 12.”

direct quote[Methods, Randomisation paragraph]

“Physicians, the steering committee, and participants were blinded.”

direct quote[Methods, Sample size paragraph]

“Accounting for an anticipated drop-out rate of 10%, a significance level of 0.05, and a power of 80%, the study required 442 women for inclusion.”

PASSReviewer 2· 90% conf

The design includes adequate randomization, blinding, a pre-specified sample size calculation, clear inclusion/exclusion criteria, and appropriate handling of outliers, though biological replicate distinction is not applicable for a human RCT.

Evidence

direct quote[Methods, Randomisation section]

“The Capital Region Pharmacy conducted randomisation using a computer generated random number sequence (1:1 allocation) in variable block sizes of six, eight, 10, and 12.”

direct quote[Methods, Sample size section]

“Accounting for an anticipated drop-out rate of 10%, a significance level of 0.05, and a power of 80%, the study required 442 women for inclusion, with a 1:1 allocation ratio.”

direct quote[Methods, Randomisation section]

“The pharmacy used sealed containers labelled with identification numbers containing either three antibiotic tablets in blister packs for shelf stability, or three placebo tablets stored loose... The pharmacy advised that a healthcare provider not involved in the study remove the blister packs, repackage the tablets, and return the container to the enrolling doctor without revealing its contents.”

PASSReviewer 3· 90% conf

The study design is rigorous with clear randomization, blinding, and sample size justification, though some sub-criteria (outlier handling, independent replication) are not applicable for this clinical RCT.

Evidence

direct quote[Methods, Randomisation paragraph]

“The Capital Region Pharmacy conducted randomisation using a computer generated random number sequence (1:1 allocation) in variable block sizes of six, eight, 10, and 12.”

direct quote[Methods, Randomisation paragraph]

“...randomisation therefore occurred before enrolment and remained blinded to the staff (except repacking individuals), the steering committee (comprising all authors), and the patients until unblinding.”

direct quote[Methods, Sample size paragraph]

“Accounting for an anticipated drop-out rate of 10%, a significance level of 0.05, and a power of 80%, the study required 442 women for inclusion, with a 1:1 allocation ratio.”

The paper reports maternal age, parity, body mass index, gestational diabetes, hypertension, and other baseline characteristics in Table 1. Sex is inherently female for all participants, and the paper notes 'all genders were eligible for inclusion.' Age and health status are reported. Race/ethnicity data are not provided, but the authors acknowledge this as a limitation regarding generalizability. Species/strain and housing conditions are not applicable for a human study.

Sub-criteria

demographicsINADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 85% conf

Sex and age/health are reported, but race/ethnicity is missing.

Evidence

direct quote[Methods, Participants]

“In this study, “women” refers to people of female sex; all genders were eligible for inclusion.”

paraphrase[Results, Table 1]

“Baseline table includes mean age, median BMI, rates of gestational diabetes, hypertension, etc.”

direct quote[Discussion, Strengths and limitations]

“Generalisability may be limited and selection bias introduced because of the single centre design, inclusion restricted to Danish-speaking women, and lack of ethnicity data.”

PASSReviewer 2· 90% conf

Sex, age, BMI, and other human demographics are well-reported. Sex is justified by the study population (women with perineal tears). Species/strain and housing conditions are not applicable for a human trial.

Evidence

direct quote[Methods, Participants]

“In this study, 'women' refers to people of female sex; all genders were eligible for inclusion.”

direct quote[Results, Table 1]

“Mean (SD) age (years): Antibiotics 31 (4.6), Placebo 32 (4.1); Median (IQR) body mass index: 22.8 (20.3-25.2), 23.1 (20.7-25.8)”

PASSReviewer 3· 95% conf

Relevant biological variables (age, sex, health status) are reported for this human clinical trial, with limitations noted for race/ethnicity data.

Evidence

direct quote[Table 1]

“Mean (SD) age (years): 31 (4.6) [antibiotics], 32 (4.1) [placebo]”

direct quote[Discussion, Strengths and limitations]

“Generalisability may be limited and selection bias introduced because of the single centre design, inclusion restricted to Danish-speaking women, and lack of ethnicity data.”

direct quote[Methods, Participants]

“In this study, 'women' refers to people of female sex; all genders were eligible for inclusion.”

The trial was approved by a named ethics committee (Danish National Committee on Health Research Ethics) and the Danish Medicines Agency, with a protocol number. Written informed consent was obtained. Compliance with Good Clinical Practice is stated.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approvals and consent are clearly reported.

Evidence

direct quote[Ethics statements]

“The trial was approved in Denmark through the EU Clinical Trials Information System (CTIS; EU No 2022-501930-49-00) by the Danish Medicines Agency and the Danish National Committee on Health Research Ethics.”

direct quote[Ethics statements]

“All participants provided written informed consent.”

PASSReviewer 2· 95% conf

Ethical approval was obtained from a named authority (Danish Medicines Agency and National Committee on Health Research Ethics via EU CTIS), and written informed consent was obtained. Regulatory compliance is stated.

Evidence

direct quote[Ethics statements]

“All participants provided written informed consent.”

PASSReviewer 3· 95% conf

The study has clear ethical approval with a named body (EU CTIS), informed consent, and regulatory compliance.

Evidence

direct quote[Methods, Study design and Ethics statements]

“Approved on 2 February 2023 (EU-CT 2022-501930-49-00) and registered at ClinicalTrials.gov (NCT05830162)”

direct quote[Ethics statements]

“All participants provided written informed consent.”

direct quote[Methods, Study design]

“...the study was monitored by the national Danish Good Clinical Practice Unit.”

The antibiotic (amoxicillin 500mg with clavulanic acid 125mg) and placebo (calcium) are fully identified with dose, regimen, and description of matching. The supplier is implied (Capital Region Pharmacy). Statistical software is identified (R Studio version 4.4.1). Antibodies, cell lines, mycoplasma, and organisms are not applicable to this purely clinical trial.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 85% conf

The investigational drug is named but not fully sourced; software is identified.

Evidence

direct quote[Abstract]

“three doses of amoxicillin (500 mg) with clavulanic acid (125 mg)”

direct quote[Methods, Statistical analysis]

“We used R Studio version 4.4.1 to perform statistical analyses.”

PASSReviewer 2· 90% conf

The investigational product (amoxicillin/clavulanic acid) and placebo are well-identified with dose, regimen, and manufacturer context. Software is identified with version. Other bench resources are not applicable for this clinical trial.

Evidence

direct quote[Methods, Intervention]

“The treatment group received three doses of oral antibiotics: amoxicillin (500 mg) with clavulanic acid (125 mg).”

direct quote[Methods, Statistical analysis]

“We used R Studio version 4.4.1 to perform statistical analyses.”

PASSReviewer 3· 90% conf

The investigational product (amoxicillin/clavulanic acid) is identified with dose and regimen, and statistical software is specified, meeting the requirements for a clinical drug trial.

Evidence

direct quote[Methods, Intervention]

“The treatment group received three doses of oral antibiotics: amoxicillin (500 mg) with clavulanic acid (125 mg)... The placebo group received three placebo tablets (calcium) matching the active drug in size, shape, and colour.”

direct quote[Methods, Statistical analysis]

“We used R Studio version 4.4.1 to perform statistical analyses.”

absence[Methods, Intervention]

Manufacturer of the drug is not specified.

Tests are named (Fisher's exact, t-test, Mann-Whitney), normality was assessed, exact p-values and 95% CIs are provided, and software is identified. Data presentation includes group sizes and risk differences.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are well described, with exact p-values and effect sizes reported.

Evidence

direct quote[Methods, Statistical analysis]

“We used Fisher’s exact test for categorical variables while continuous variables were analysed using the t test when normally distributed and using the Mann-Whitney U test when not normally distributed.”

paraphrase[Results, Table 2]

“Primary outcome P=0.10, risk difference -7.2% (95% CI -15.4% to 0.8%); secondary outcome P=0.01, risk difference -8.0% (95% CI -14.3% to -1.8%).”

direct quote[Methods, Statistical analysis]

“Variables with normal distribution were summarised using means and standard deviations (SDs). Non-normally distributed data were presented as medians with interquartile ranges.”

PASSReviewer 2· 85% conf

Statistical tests are named, assumptions are verified for continuous variables, exact p-values and effect sizes with CIs are reported, software is identified, and data presentation is adequate. Mathematical plausibility checks are broadly satisfied.

Evidence

direct quote[Methods, Statistical analysis]

“We used Fisher's exact test for categorical variables while continuous variables were analysed using the t test when normally distributed and using the Mann-Whitney U test when not normally distributed. ...continuous data were evaluated for normal distribution with visual evaluation (histograms and Q-Q plots).”

direct quote[Results, Table 2]

“P=0.10; risk difference −7.2% (95% CI −15.4% to 0.8%)”

PASSReviewer 3· 85% conf

Statistical tests are named, p-values and effect sizes with CIs are reported, and data presentation is adequate for a clinical trial. Assumption verification is partially reported but adequate given the large sample and standard methods.

Evidence

direct quote[Methods, Statistical analysis]

direct quote[Results, Outcomes and Table 2]

“For clinically relevant wound complications, significantly fewer events occurred in the treatment group (19/218, 9% v 36/215, 17%; P=0.01), with a risk difference of −8.0% (95% CI −14.3% to −1.8%) and a relative risk of 0.52 (0.31 to 0.88).”

direct quote[Methods, Statistical analysis]

“For baseline data, amount and percentages were provided for categorical data, while continuous data were evaluated for normal distribution with visual evaluation (histograms and Q-Q plots).”

A data availability statement is present and provides a direct link to a public repository (Dataverse) with a DOI. This is considered adequate. Code is shared as supplementary files (R code). For a clinical trial with patient-level data, repository deposit of de-identified data is acceptable and provided here.

Sub-criteria

code sharingINADEQUATE

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 85% conf

Data are openly available, but code is only in supplemental files.

Evidence

direct quote[Data availability statement]

“The data underlying the findings in this paper are openly and publicly available and can be found here: https://dataverse.deic.dk/dataset.xhtml?persistentId=doi:10.60612/DATADK/WTK5BD”

direct quote[Data availability statement]

“The code used to analyse the data in the paper can be found in the supplemental files.”

PASSReviewer 2· 90% conf

Data are openly available in a public repository with a DOI, and code is provided in supplementary files. The data availability statement is concrete and adequate.

Evidence

direct quote[Data availability statement]

“The data underlying the findings in this paper are openly and publicly available and can be found here: https://dataverse.deic.dk/dataset.xhtml?persistentId=doi:10.60612/DATADK/WTK5BD”

direct quote[Data availability statement]

“The code used to analyse the data in the paper can be found in the supplemental files.”

PASSReviewer 3· 90% conf

Data are openly available in a public repository with a DOI, and code is provided in supplemental files. The data availability statement is concrete.

Evidence

direct quote[Data availability statement]

“The data underlying the findings in this paper are openly and publicly available and can be found here: https://dataverse.deic.dk/dataset.xhtml?persistentId=doi:10.60612/DATADK/WTK5BD”

direct quote[Data availability statement]

“The code used to analyse the data in the paper can be found in the supplemental files.”

direct quote[Data availability statement]

“doi:10.60612/DATADK/WTK5BD”

All methods are detailed. The trial is registered in two registries. CONSORT 2010 is followed. Both primary (non-significant) and secondary (significant) outcomes are reported. Limitations are discussed. Conclusions are proportional to the evidence. Funding and conflicts are declared.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study is comprehensively reported with trial registration, CONSORT adherence, and balanced conclusions.

Evidence

direct quote[Abstract]

“Trial registration Clinical Trials Information System (euclinicaltrials.eu) 2022-501930-49-00 and ClinicalTrials.gov NCT05830162”

direct quote[Methods, Study design]

“the present study adheres to the CONSORT 2010 guidelines.”

direct quote[Discussion, Strengths and limitations]

“One limitation is that the outcome of clinically relevant wound dehiscence was registered at ClinicalTrials.gov after study initiation, although it was defined before study initiation and assessed prospectively throughout.”

PASSReviewer 2· 90% conf

Methods are comprehensive, the trial is registered, CONSORT guidelines are followed, negative results are reported, limitations are discussed, conclusions are proportional, and funding/COI are disclosed.

Evidence

direct quote[Abstract, Trial registration; Methods, Study design]

“Clinical Trials Information System (euclinicaltrials.eu) 2022-501930-49-00 and ClinicalTrials.gov NCT05830162”

direct quote[Methods, Study design]

“the present study adheres to the CONSORT 2010 guidelines.”

direct quote[Discussion, Strengths and limitations]

PASSReviewer 3· 95% conf

The study is comprehensively reported with trial registration, adherence to CONSORT, discussion of limitations, and proportional conclusions.

Evidence

direct quote[Abstract and Methods]

“Trial registration Clinical Trials Information System (euclinicaltrials.eu) 2022-501930-49-00 and ClinicalTrials.gov NCT05830162”

direct quote[Methods, Study design]

“...while the present study adheres to the CONSORT 2010 guidelines.”

direct quote[Discussion, Strengths and limitations]

“One limitation is that the outcome of clinically relevant wound dehiscence was registered at ClinicalTrials.gov after study initiation... Generalisability may be limited and selection bias introduced because of the single centre design, inclusion restricted to Danish-speaking women, and lack of ethnicity data.”

2 copyedit issues flagged: mostly consistency, other.

Checked 24 references: 17 verified — 7 not checked.

Reproducibility

2 data/code links checked; 2 live.

Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

Adcurare Rigor Action ItemsFinal pass before journal submission

Ready after minor edits. The two warn-dimension gaps (drug manufacturer, code repository) and the copyedit issues (spelling consistency, code link) should be addressed before submission; none of these affect the scientific validity of the trial.

1.
HIGHrigor
Add the manufacturer/source (including city/country) for amoxicillin/clavulanic acid and placebo tablets in the Methods, Intervention section.
Reagent identification standards require a traceable source for reproducibility; reviewers and editors will flag this absence.
2.
HIGHdata code
Deposit the analysis code in a version-controlled public repository (e.g., GitHub, Zenodo) with a persistent DOI, and update the Data Availability Statement to reference the repository link.
Code in supplemental files is less discoverable and reproducible; a public repository with a persistent identifier is the standard for code sharing.
3.
MEDIUMreporting
Explicitly state how each limitation of prior work (high loss to follow-up, no placebo control, no clinical consultation) is addressed by the current study design in the Introduction.
Strengthens the scientific premise by showing a systematic approach to mitigating known weaknesses, as recommended by reporting guidelines.
4.
MEDIUMreporting
Include a statement in Methods, Randomisation on how the randomization code was generated (specific software or algorithm) and whether data analysts were blinded during analysis.
Improves reproducibility and transparency of the randomization and analysis phases, as suggested by one reviewer.
5.
MEDIUMreporting
Provide a direct hyperlink to the supplemental files containing the analysis code in the Data Availability Statement.
The copyedit pass noted that a direct URL would improve accessibility; currently only a vague statement is given.
6.
MEDIUMreporting
Report the exact time (hours post-delivery) of the first antibiotic dose relative to delivery in the Methods, Intervention section.
Allows secondary analyses of timing effects and improves reproducibility of the intervention protocol.
7.
MEDIUMreporting
Add a formal power calculation or justification for the secondary outcome (clinically relevant wound complications) in the Methods, Sample size or Discussion.
Helps readers interpret the significance of the secondary finding and assess whether it was adequately powered.
8.
LOWreporting
Report the number of women screened, eligible, and enrolled (if not already in the CONSORT flow diagram) to fully document the selection process.
Improves assessment of selection bias and external validity, as noted by one reviewer.
9.
LOWreporting
Describe the method for handling missing data in the primary ITT analysis (e.g., multiple imputation, complete-case) in the Methods, Statistical analysis section.
Currently only ITT is stated; specifying how missing outcomes were handled strengthens the robustness of the analysis.
10.
LOWcopyedit
Unify spelling of 'randomization' (American) and 'randomisation' (British) throughout the manuscript, choosing one style consistently.
Minor consistency issue flagged by the copyedit pass; a clean manuscript avoids such distractions.
11.
LOWreporting
Explicitly note that race/ethnicity data were not collected (already acknowledged as a limitation) and consider stating this in the Methods, Participants section.
Addresses the 'reported_but_inadequate' rating for demographics by making the absence transparent.

Full text (35,287 chars)Analyzed: Jul 7, 2026

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