Kaimen 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: Kaimen Rigor review — 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: 59
Author: Alpha1

Perslev K, Klarskov N, Bergholt T, Jangö H

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Kaimen Rigor review — 3.25★ (Adequate), 0 critical, 3 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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This rigor review was examined and confirmed by Alpha1 Editorial · August 10, 2026

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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.

Perslev K, Klarskov N, Bergholt T, Jangö H

Read full text (PMC)

DOI

10.1136/bmj-2025-084312

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Kaimen 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.

Perslev K, Klarskov N, Bergholt T, Jangö H

Paper source

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.

Read full text (PMC)

Embed this Rigor badge

Links back to this Kaimen Rigor review.

Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 10, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

Incomplete run — read this verdict with care

Only 2 of 3 reviewers completed. Each verdict below is the majority of 2, not of 3 — the disagreement between reviewers that normally filters out one model's noise could not be applied.
This run hit its time budget: at least one step billed work that never produced a result.

3.25 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
ReportingKey resources partially met−0.25★
ReportingStatistical analysis partially met−0.25★
ReportingData & code availability partially met−0.25★

Model-reported confidence: moderateReviewer agreement: highEngine: 7.29.0Source: full text

Biggest issues

01Other integrity concern
mediumAuthenticityreviewer-assessedFull detail
Trial NCT05830162 was first submitted to ClinicalTrials.gov on 2023-03-29, after the registered study start date of 2023-03-21. Retrospective registration means the protocol and outcomes were not on the public record before the study ran, which is what prospective registration exists to establish.
NCT05830162
reviewer’s wording

Findings by category

01ArithmeticNone found 102OverreachOverstated conclusions 103AuthenticityData authenticity concerns 304DisclosureReporting gaps · partly checked 05AvailabilityNone found 06Copyedit4 minor suggestions

This Kaimen Rigor review uses Kaimen 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.

The REPAIR trial is a methodologically strong, well-designed double-blind placebo-controlled RCT with rigorous randomisation, blinding, power analysis, transparent reporting, dual registration, CONSORT adherence, and openly available data. The main weaknesses are reporting gaps rather than validity threats: the investigational drug manufacturer is not stated, one p-value is reported only as a threshold, the analysis code is only in supplemental files, and registration was retrospective with the headline recommendation resting on a secondary outcome added after study initiation.

Two independent reviewer runs were reconciled; they agreed on six dimensions and diverged on statistical analysis (warn vs pass) and on the demographics sub-criterion (ethnicity). The statistics verification recomputed only 4 tests reported with test statistics/df or effect estimates with CIs (all consistent); threshold-only, exact/permutation p-values and GRIM/GRIMMER checks (inapplicable to continuous measurements) are not verified. All 22 references were located with none retracted, and both data links are live. Criteria not applicable to a human obstetric drug trial were excluded.

Numerical inconsistencies

None found

Values that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.

Checked — nothing surfaced.

Recomputed 4 tests: 4 consistent, 0 inconsistent; 4 via agent-written checks.

Overstated conclusions

1 finding · worst low

Conclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.

Conclusions only partially backed by the presented evidenceAssessed

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

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

Data authenticity concerns

1 finding · worst medium

An adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.

Other integrity concernAssessed

2 integrity concerns flagged (0 high).

Reporting gaps

3 findings · worst high

Required detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.

Statistical reporting gaps (tests, assumptions, effect sizes)Assessed
Data/code availability incompleteAssessed
Key resources under-identified (antibodies, cell lines, RRIDs)Assessed

Eight Dimensions5 pass · 3 warn

Prior work is cited with explicit acknowledgment of limitations (e.g., high loss to follow-up, lack of placebo control, methodological weaknesses). The rationale linking the evidence gap to the study objective is explicit, and the design addresses prior limitations (e.g., placebo control, defined outcomes, low drop-out rate).

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The introduction clearly establishes the scientific gap, cites prior work (Cochrane reviews, ANODE trial), and logically motivates the study hypothesis.

Evidence

“A Cochrane review evaluated prophylactic antibiotics for obstetric anal sphincter injury, but included only one randomised controlled trial, which reported a reduction in healing complications from 24% to 8% following a single intravenous dose of antibiotics. The loss to follow-up was high, prompting the authors to recommend cautious data interpretation.”

Introduction ¶2Find in source

“Even less data are available on the effect of prophylactic antibiotics after the most common obstetric tears: episiotomies and second degree tears.”

Introduction ¶3Find in source

paraphrase[Methods, Study design]

“Paraphrase: The REPAIR study used a double-blind, placebo-controlled design to overcome the lack of placebo control in prior trials.”

PASSReviewer 2· 90% conf

The scientific premise is well established through a thorough review of prior Cochrane reviews, the ANODE trial, and other studies, with clear acknowledgement of their limitations and a logical rationale for the current trial.

Evidence

“A 2017 Cochrane review evaluated antibiotic use after episiotomy but included only one study with methodological limitations. The review concluded that evidence was not sufficient to recommend prophylactic antibiotic use.”

IntroductionFind in source

“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.”

IntroductionFind in source

All applicable design elements are adequately reported: randomisation method (computer-generated variable block sizes), randomisation unit (participant), blinding (double-blind, with detailed measures to maintain blinding despite packaging differences), a priori sample size calculation (based on 50% reduction, alpha 0.05, power 80%, 10% drop-out), and inclusion/exclusion criteria. Outlier handling is addressed through ITT, per-protocol, and extreme-case sensitivity analyses. Replicate distinction, controls, and independent replication are not applicable 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 (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The randomised trial is rigorously designed with computer-generated randomisation, blinding, a priori power calculation, pre-specified inclusion/exclusion criteria, and clear handling of missing data and outliers.

Evidence

“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.”

MethodsFind in source

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

AbstractFind in source

“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.”

MethodsFind in source

PASSReviewer 2· 90% conf

A rigorously designed double-blind placebo-controlled RCT with adequate randomisation (computer-generated variable block sizes), blinding of physicians, steering committee and participants, a pre-specified power calculation, explicit inclusion/exclusion criteria, and ITT plus per-protocol analyses.

Evidence

“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.”

MethodsFind in source

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

AbstractFind in source

“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.”

MethodsFind in source

Sex is reported (all participants are postpartum women). Age, weight (BMI) and health status are reported in Table 1 (e.g., mean age 31 vs 32 years, median BMI 22.8 vs 23.1, gestational diabetes, hypertension). Demographics include age, parity, BMI, and comorbidities; ethnicity was not collected, which the authors explicitly disclose as a limitation. Sex justification is n/a because the condition (obstetric tears) affects only women. Species/strain and housing are n/a for a human trial.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 80% conf

Biological variables relevant to a human obstetric trial are well reported for age, weight/BMI, and comorbidities, though ethnicity is not reported (acknowledged as a limitation).

Evidence

“Mean (SD) age (years) | 0 | 31 (4.6) | 32 (4.1)”

Table 1Find in source

“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.”

LimitationsFind in source

PASSReviewer 2· 85% conf

Age, BMI/weight, health status (gestational diabetes, pre-eclampsia) and key demographics are reported in the baseline table; the study population is inherently female. Ethnicity is not reported but is acknowledged as a limitation.

Evidence

“Mean (SD) age (years) | 0 | 31 (4.6) | 32 (4.1)”

Table 1Find in source

“This information included maternal age, parity, body mass index, gestational diabetes, pre-eclampsia, and previous or current psychological difficulties”

MethodsFind in source

The ethical approval statement names the competent authorities (Danish Medicines Agency and the Danish National Committee on Health Research Ethics) via the EU CTIS system, with a protocol number. Written informed consent is explicitly stated. Regulatory compliance is evidenced by monitoring by the Danish Good Clinical Practice Unit and adherence to CONSORT.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial received named ethics approval from the Danish Medicines Agency and the Danish National Committee on Health Research Ethics, and all participants provided written informed consent.

Evidence

“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.”

EthicsFind in source

“All participants provided written informed consent.”

EthicsFind in source

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

MethodsFind in source

PASSReviewer 2· 95% conf

Ethical approval by a named national ethics committee with a protocol/EU number and written informed consent are both explicitly reported, along with Good Clinical Practice monitoring.

Evidence

EthicsFind in source

“All participants provided written informed consent.”

EthicsFind in source

The drug is described with formulation (oral), strength (500 mg amoxicillin + 125 mg clavulanic acid), and dose regimen (three doses at 8-hour intervals), and the placebo is described as calcium tablets. However, no manufacturer or source is specified for either the drug or placebo. The statistical software (R Studio version 4.4.1) is identified. Antibodies, cell lines, mycoplasma, and organisms are not applicable in this clinical trial. Therefore, 1 of 2 applicable criteria is adequate.

Sub-criteria

mycoplasma testingN/A

reagents identifiedINADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 70% conf

The investigational drug (amoxicillin/clavulanic acid) and placebo are named with dose and regimen, but the manufacturer/source is not provided; analysis software is identified. This is a minor identification gap.

Evidence

paraphrase[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.”

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

Statistical analysisFind in source

WARNReviewer 2· 60% conf

The investigational product (amoxicillin-clavulanic acid) is named with strength, dose and regimen, and the analysis software (R Studio 4.4.1) is identified with version, but the manufacturer/source of the drug is not stated.

Evidence

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

MethodsFind in source

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

Statistical analysisFind in source

All applicable statistical elements are adequate except exact_p_values: the paper reports most p-values exactly (e.g., P=0.10, P=0.01), but uses '<0.001' for the wound dehiscence median difference. Tests are named (Fisher's exact, t-test, Mann-Whitney U), assumptions are checked via histograms and Q-Q plots, effect sizes with 95% CIs are presented, software is identified, and data presentation includes per-group n and CIs. No arithmetic errors were found in the reported percentages and risk differences.

Sub-criteria

tests namedADEQUATE

exact p valuesINADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 75% conf

Statistical methods are generally well reported (tests named, assumptions checked, effect sizes with CIs), but one p-value is reported only as a threshold ('<0.001') rather than as an exact value, constituting imprecise reporting.

Evidence

“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.”

Statistical analysisFind in source

“Median (IQR) wound dehiscence (mm) | 7 (6-10) | 10 (7-12) | <0.001”

Table 2Find in source

“with a risk difference of −7.2% (95% confidence interval (CI) −15.4% to 0.8%) and a relative risk of 0.75 (0.54 to 1.04).”

AbstractFind in source

PASSReviewer 2· 85% conf

Statistical tests are named, normality was visually assessed, exact p-values and effect sizes with 95% CIs are reported, software is identified, and the reported percentages are arithmetically plausible.

Evidence

paraphrase[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.”

“We also calculated the risk difference, relative risk, and number needed to treat with 95% confidence intervals (CIs).”

Statistical analysisFind in source

The data availability statement names a concrete repository (dataverse.deic.dk) with a persistent identifier (DOI), and the data are openly available. However, the code is described as being in 'supplemental files,' which does not meet the standard of a version-controlled public repository with a permanent identifier. Since 2 of 3 applicable criteria are adequate, the dimension is rated warn.

Sub-criteria

code sharingINADEQUATE

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

Data are openly available in a repository with a DOI and a data availability statement is present, but the analysis code is only provided as supplemental files rather than in a version-controlled public repository.

Evidence

“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”

Data availabilityFind in source

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

Data availabilityFind in source

WARNReviewer 2· 70% conf

De-identified data are openly deposited in a Dataverse repository with a DOI and a clear availability statement, but the analysis code is only in supplemental files rather than a version-controlled public repository.

Evidence

“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”

Data availabilityFind in source

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

Data availabilityFind in source

Methods are comprehensive and reference a protocol paper. Trial registration numbers for both EU-CTIS and ClinicalTrials.gov are given. The paper adheres to CONSORT 2010. All pre-specified outcomes (primary, secondary, exploratory) are reported, including non-significant results, and limitations are explicitly discussed. Conclusions are proportional to the evidence, acknowledging the primary outcome was non-significant. Funding and competing interests are declared.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The manuscript is well reported: methods are detailed, trial registration is provided, CONSORT is followed, all outcomes are reported, limitations are discussed, conclusions are proportional, and funding/COI are declared.

Evidence

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

AbstractFind in source

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

MethodsFind in source

“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.”

LimitationsFind in source

PASSReviewer 2· 90% conf

The manuscript is transparently reported with dual trial registration, CONSORT adherence, disclosure of a secondary outcome added after initiation, a thorough limitations section, and funding/COI statements.

Evidence

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

AbstractFind in source

“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.”

LimitationsFind in source

“The study was funded by the Research Unit and the Department of Gynaecology and Obstetrics at Herlev Hospital.”

FundingFind in source

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

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 22 references by DOI: 17 verified — 5 no DOI (shown, not verified).

2 data/code links checked; 2 live.

Copyediting

4 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 4 minor suggestions below.

4 copyedit issues flagged: mostly consistency, clarity, other.

Kaimen Rigor Action ItemsFinal pass before journal submission

As a post-publication audit, the published REPAIR trial is robust: the design, ethics, transparency, and open data are strong, and no detected issue invalidates the reported results. An informed reader should weigh the retrospective registration timing, the recommendation carried by a secondary outcome added after initiation while the primary was non-significant, the missing drug manufacturer/source, and the single threshold-only p-value; none warrant a formal correction of the results, and the open data and code enable independent re-analysis.

1.
HIGHreporting
Clarify in the trial-registration section why NCT05830162 was first submitted to ClinicalTrials.gov on 2023-03-29, after the registered study start date of 2023-03-21, and state plainly whether registration was prospective.
Retrospective registration undermines the prospective-registration guarantee that the protocol and outcomes were fixed on the public record before the study ran.
2.
HIGHdata code
Deposit the analysis code in a version-controlled public repository (e.g., GitHub or Zenodo) with a persistent DOI and cite it in the Data availability statement instead of only supplemental files.
Code in supplemental files lacks version control and a permanent identifier, limiting reproducibility.
3.
HIGHreporting
Specify the manufacturer/source and lot numbers of the amoxicillin/clavulanic acid and the placebo (calcium) tablets in Methods/Intervention.
The investigational product is currently identified only by name, strength and regimen, which is an incomplete resource identification.
4.
MEDIUMstatistics
Replace the threshold-only p-value '<0.001' for wound dehiscence in Table 2 with the exact computed value.
A p-value the authors computed should be reported exactly rather than as a threshold; this is the sole imprecise-reporting element in the statistics.
5.
MEDIUMreporting
Report the exact post-partum timing of the first antibiotic/placebo dose, or state explicitly that it was not recorded and discuss the implication for efficacy interpretation.
The Discussion notes the exact timepoint was not recorded, which is relevant to interpreting the treatment effect.
6.
MEDIUMcopyedit
Fix Table 1 fetal-presentation rows: populate the 'No of participants with missing information' column for occiput posterior and breech rows, and reconcile the occiput anterior missing count (14) with the reported counts (199+11+2=212 vs 218−14=204).
The blank column and the count discrepancy create an apparent internal inconsistency that a reader could construe as an error.
7.
MEDIUMstatistics
State in Methods/Statistical analysis whether any multiple-testing correction was applied to the exploratory outcomes.
The exploratory outcomes are numerous and not pre-specified, so readers need to know whether multiplicity was addressed.
8.
MEDIUMreporting
Add race/ethnicity data to Table 1 if available, or make the absence and its impact on generalisability more prominent in the limitations.
Ethnicity was not collected and the population was restricted to Danish-speaking women, limiting generalisability.
9.
MEDIUMreporting
Qualify the routine-practice recommendation for prophylactic antibiotics, which rests on a secondary outcome added to the registry after study initiation while the primary outcome was non-significant.
A headline conclusion carried by a post-hoc-added secondary outcome should be tempered to what the primary evidence supports.
10.
LOWcopyedit
Remove the stray header artifact '391 e084312 e084312'.
It is a typesetting artifact rather than a substantive error, but it should be cleaned for a polished record.
11.
LOWcopyedit
Clarify the kidney-function statement in Methods/Drug treatment to specify that no dose adjustment applies to amoxicillin/clavulanic acid for courses under one week and whether renal function was assessed.
The statement is a general guideline and would be clearer if tied to the specific drug and population.

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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.

Perslev K, Klarskov N, Bergholt T, Jangö H

Read full text (PMC)

DOI

10.1136/bmj-2025-084312

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Record fingerprint

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Issued Aug 10, 2026Engine 7.29.0

Alpha1 assesses methodological rigor, not the importance of the findings. See how we calibrate →

Kaimen Rigor review

Kaimen Rigor reviewed

Incomplete run — read this verdict with care

Only 2 of 3 reviewers completed. Each verdict below is the majority of 2, not of 3 — the disagreement between reviewers that normally filters out one model's noise could not be applied.
This run hit its time budget: at least one step billed work that never produced a result.

3.25 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
ReportingKey resources partially met−0.25★
ReportingStatistical analysis partially met−0.25★
ReportingData & code availability partially met−0.25★

Model-reported confidence: moderateReviewer agreement: highEngine: 7.29.0Source: full text

Biggest issues

01Other integrity concern
mediumAuthenticityreviewer-assessedFull detail
Trial NCT05830162 was first submitted to ClinicalTrials.gov on 2023-03-29, after the registered study start date of 2023-03-21. Retrospective registration means the protocol and outcomes were not on the public record before the study ran, which is what prospective registration exists to establish.
NCT05830162
reviewer’s wording

Findings by category

Numerical inconsistencies

None found

Checked — nothing surfaced.

Recomputed 4 tests: 4 consistent, 0 inconsistent; 4 via agent-written checks.

Overstated conclusions

1 finding · worst low

Conclusions only partially backed by the presented evidenceAssessed

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

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

Data authenticity concerns

1 finding · worst medium

Other integrity concernAssessed

2 integrity concerns flagged (0 high).

Reporting gaps

3 findings · worst high

Statistical reporting gaps (tests, assumptions, effect sizes)Assessed
Data/code availability incompleteAssessed
Key resources under-identified (antibodies, cell lines, RRIDs)Assessed

Eight Dimensions5 pass · 3 warn

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The introduction clearly establishes the scientific gap, cites prior work (Cochrane reviews, ANODE trial), and logically motivates the study hypothesis.

Evidence

Introduction ¶2Find in source

“Even less data are available on the effect of prophylactic antibiotics after the most common obstetric tears: episiotomies and second degree tears.”

Introduction ¶3Find in source

paraphrase[Methods, Study design]

“Paraphrase: The REPAIR study used a double-blind, placebo-controlled design to overcome the lack of placebo control in prior trials.”

PASSReviewer 2· 90% conf

Evidence

IntroductionFind in source

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Evidence

“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.”

MethodsFind in source

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

AbstractFind in source

“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.”

MethodsFind in source

PASSReviewer 2· 90% conf

Evidence

“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.”

MethodsFind in source

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

AbstractFind in source

“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.”

MethodsFind in source

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 80% conf

Biological variables relevant to a human obstetric trial are well reported for age, weight/BMI, and comorbidities, though ethnicity is not reported (acknowledged as a limitation).

Evidence

“Mean (SD) age (years) | 0 | 31 (4.6) | 32 (4.1)”

Table 1Find in source

“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.”

LimitationsFind in source

PASSReviewer 2· 85% conf

Evidence

“Mean (SD) age (years) | 0 | 31 (4.6) | 32 (4.1)”

Table 1Find in source

“This information included maternal age, parity, body mass index, gestational diabetes, pre-eclampsia, and previous or current psychological difficulties”

MethodsFind in source

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial received named ethics approval from the Danish Medicines Agency and the Danish National Committee on Health Research Ethics, and all participants provided written informed consent.

Evidence

EthicsFind in source

“All participants provided written informed consent.”

EthicsFind in source

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

MethodsFind in source

PASSReviewer 2· 95% conf

Ethical approval by a named national ethics committee with a protocol/EU number and written informed consent are both explicitly reported, along with Good Clinical Practice monitoring.

Evidence

EthicsFind in source

“All participants provided written informed consent.”

EthicsFind in source

Sub-criteria

mycoplasma testingN/A

reagents identifiedINADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 70% conf

Evidence

paraphrase[Methods, Intervention]

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

Statistical analysisFind in source

WARNReviewer 2· 60% conf

Evidence

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

MethodsFind in source

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

Statistical analysisFind in source

Sub-criteria

tests namedADEQUATE

exact p valuesINADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 75% conf

Evidence

Statistical analysisFind in source

“Median (IQR) wound dehiscence (mm) | 7 (6-10) | 10 (7-12) | <0.001”

Table 2Find in source

“with a risk difference of −7.2% (95% confidence interval (CI) −15.4% to 0.8%) and a relative risk of 0.75 (0.54 to 1.04).”

AbstractFind in source

PASSReviewer 2· 85% conf

Evidence

paraphrase[Methods, Statistical analysis]

“We also calculated the risk difference, relative risk, and number needed to treat with 95% confidence intervals (CIs).”

Statistical analysisFind in source

Sub-criteria

code sharingINADEQUATE

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

Evidence

“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”

Data availabilityFind in source

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

Data availabilityFind in source

WARNReviewer 2· 70% conf

Evidence

“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”

Data availabilityFind in source

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

Data availabilityFind in source

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Evidence

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

AbstractFind in source

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

MethodsFind in source

LimitationsFind in source

PASSReviewer 2· 90% conf

Evidence

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

AbstractFind in source

“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.”

LimitationsFind in source

“The study was funded by the Research Unit and the Department of Gynaecology and Obstetrics at Herlev Hospital.”

FundingFind in source

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

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 22 references by DOI: 17 verified — 5 no DOI (shown, not verified).

2 data/code links checked; 2 live.

Copyediting

4 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 4 minor suggestions below.

4 copyedit issues flagged: mostly consistency, clarity, other.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHreporting
Clarify in the trial-registration section why NCT05830162 was first submitted to ClinicalTrials.gov on 2023-03-29, after the registered study start date of 2023-03-21, and state plainly whether registration was prospective.
Retrospective registration undermines the prospective-registration guarantee that the protocol and outcomes were fixed on the public record before the study ran.
2.
HIGHdata code
Deposit the analysis code in a version-controlled public repository (e.g., GitHub or Zenodo) with a persistent DOI and cite it in the Data availability statement instead of only supplemental files.
Code in supplemental files lacks version control and a permanent identifier, limiting reproducibility.
3.
HIGHreporting
Specify the manufacturer/source and lot numbers of the amoxicillin/clavulanic acid and the placebo (calcium) tablets in Methods/Intervention.
The investigational product is currently identified only by name, strength and regimen, which is an incomplete resource identification.
4.
MEDIUMstatistics
Replace the threshold-only p-value '<0.001' for wound dehiscence in Table 2 with the exact computed value.
A p-value the authors computed should be reported exactly rather than as a threshold; this is the sole imprecise-reporting element in the statistics.
5.
MEDIUMreporting
Report the exact post-partum timing of the first antibiotic/placebo dose, or state explicitly that it was not recorded and discuss the implication for efficacy interpretation.
The Discussion notes the exact timepoint was not recorded, which is relevant to interpreting the treatment effect.
6.
MEDIUMcopyedit
Fix Table 1 fetal-presentation rows: populate the 'No of participants with missing information' column for occiput posterior and breech rows, and reconcile the occiput anterior missing count (14) with the reported counts (199+11+2=212 vs 218−14=204).
The blank column and the count discrepancy create an apparent internal inconsistency that a reader could construe as an error.
7.
MEDIUMstatistics
State in Methods/Statistical analysis whether any multiple-testing correction was applied to the exploratory outcomes.
The exploratory outcomes are numerous and not pre-specified, so readers need to know whether multiplicity was addressed.
8.
MEDIUMreporting
Add race/ethnicity data to Table 1 if available, or make the absence and its impact on generalisability more prominent in the limitations.
Ethnicity was not collected and the population was restricted to Danish-speaking women, limiting generalisability.
9.
MEDIUMreporting
Qualify the routine-practice recommendation for prophylactic antibiotics, which rests on a secondary outcome added to the registry after study initiation while the primary outcome was non-significant.
A headline conclusion carried by a post-hoc-added secondary outcome should be tempered to what the primary evidence supports.
10.
LOWcopyedit
Remove the stray header artifact '391 e084312 e084312'.
It is a typesetting artifact rather than a substantive error, but it should be cleaned for a polished record.
11.
LOWcopyedit
Clarify the kidney-function statement in Methods/Drug treatment to specify that no dose adjustment applies to amoxicillin/clavulanic acid for courses under one week and whether renal function was assessed.
The statement is a general guideline and would be clearer if tied to the specific drug and population.

Full text (34,938 chars)Analyzed: Aug 10, 2026