Rigor Reviewed

Rigor-Reviewed Manuscript

A Multicomponent Intervention to Improve Maternal Infection Outcomes.

Name: Adcurare Rigor Record — A Multicomponent Intervention to Improve Maternal Infection Outcomes.
Item: A Multicomponent Intervention to Improve Maternal Infection Outcomes.
Rating: 59
Author: Adcurare

Lissauer D, Gadama L, Waitt C, Whyte S, Burnside G, Anilkumar A, Makuluni R, Okwaro P, Yang L, Waitt P, Musopole O, Bilesi R, Maseko B, Lwasa J, Mugahi R, Olaro C, Lamorde M, Makuta M, Kachiwaya C, Mkandawire T, Malunga A, Chitsulo N, Abitimo P, Ayabo T, Weeks A, Martin J, Hemming K, Gallos I, Monk EJM, Riches J, Chapuma C, Nanyondo S J, Lorencatto F, Monahan M, Allegranzi B, Dunlop C, Atkins L, Rosala-Hallas A, Roberts T, Gamble C, Malata A, Desmond N, Kommwa E, Merriel A, Parry-Smith W, Smith R, Ndumu I, Williams E, Faque B, Banda G, Nyondo-Mipando AL, Twimukye A, Chater T, Diplas A, Brizuela V, Souza JP, Rylance J, Cheshire J, Hawker L, Coomarasamy A, Bonet M

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Adcurare Rigor Review — 4★ (Strong), 0 critical, 6 high issues for “A Multicomponent Intervention to Improve Maternal Infection Outcomes.”

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Adcurare Editorial

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

Adcurare Rigor Review

Rigor Reviewed

4 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

ReportingBiological variables partially met−0.25★
ReportingEthical approvals partially met−0.25★
ReportingKey resources partially met−0.25★
ReportingData & code availability partially met−0.25★

Model-reported confidence: moderateReviewer agreement: lowEngine: 7.6.0Source: full text

Problems surfaced4 types

Biological variables underreported (sex, age, strain)
Data/code availability incomplete
Ethics/consent reporting incomplete
Key resources under-identified (antibodies, cell lines, RRIDs)

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.

The manuscript reports a well-designed cluster-randomized trial with strong methodological foundations (minimization randomization, pre-specified analyses, blinded outcome adjudication). The main rigor gaps are the absence of a data availability statement (fail), incomplete reporting of participant demographics (warn), missing software identification and model assumption verification (warn), and a missing explicit regulatory compliance statement (warn).

All eight dimensions were evaluated; key resources was scored as applicable because the trial involves an investigational product (the FAST-M bundle including antibiotics). The independent reviewers diverged on data code availability (fail vs warn) and biological variables (warn vs pass); the synthesized judgments are based on a conservative interpretation of the evidence.

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

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

Reporting

Eight Dimensions4 pass · 4 warn

The background cites multiple global studies on maternal infection mortality and morbidity, WHO recommendations, and prior work on sepsis bundles, establishing a clear premise. The rationale linking inconsistent guideline adherence to preventable deaths and the need for a multicomponent intervention is logically presented. Limitations of prior work (e.g., no trial of a maternal sepsis bundle in low-resource settings) are explicitly addressed as motivation for the trial.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper clearly establishes the scientific foundation with well-cited prior work and a logical rationale, though limitations of prior studies are only briefly acknowledged.

Evidence

direct quote[Introduction, first paragraph]

“Maternal infection is an important cause of maternal morbidity and mortality worldwide, contributing to as many as half of in-hospital maternal deaths, with the greatest burden observed in low- and middle-income countries.”

direct quote[Introduction, second paragraph]

“The Active Prevention and Treatment of Maternal Sepsis (APT-Sepsis) program was designed to address these deficiencies through an integrated, facility-level multicomponent intervention.”

absence[Introduction]

Limitations of prior research are not explicitly addressed.

PASSReviewer 2· 95% conf

The paper clearly establishes the burden of maternal infection and sepsis, cites relevant prior work and WHO guidelines, and logically motivates the intervention to address known care deficiencies.

Evidence

paraphrase[Introduction, paragraphs 1-3]

“The introduction cites references 1-18 and states that structured bundles have improved outcomes for other obstetric emergencies but a maternal sepsis bundle effect has not been established.”

direct quote[Introduction, paragraph 3]

“Several upstream deficiencies in care are critical contributors to maternal deaths from sepsis, including inconsistent adherence to infection-prevention practices, inappropriate antibiotic use and delays in the recognition and treatment of infection and sepsis.”

PASSReviewer 3· 95% conf

The paper clearly establishes the burden of maternal infection and sepsis in low- and middle-income countries, cites prior work including WHO guidelines and bundle-based interventions for other obstetric emergencies, and logically motivates the trial.

Evidence

direct quote[Background, paragraphs 1–4]

“A maternal sepsis bundle has been developed specifically for low resource settings, but its effect on maternal outcomes has not been established.”

direct quote[Background, paragraphs 2–3]

“Structured tools and bundles of care have been shown to improve recognition, timely treatment and outcomes for other obstetric emergencies such as postpartum hemorrhage, even in resource constrained health facilities.”

paraphrase[Background, paragraph 4]

“The paper states the maternal sepsis bundle had not been tested, which is a gap rather than a limitation of prior work per se, and does not formally address prior work's limitations.”

Randomization used a minimization algorithm with a random element (90%/10% probability), stated and adequate. The unit of randomization is the health facility (cluster). Blinding of participants and staff was not feasible, but the primary outcome was adjudicated by a blinded case classification committee, and study staff recording outcomes were independent of the implementation team. The a priori power analysis is detailed (95% power, two-sided alpha 0.05, ICC 0.03, cluster autocorrelation 0.97) with a pre-specified re-estimation based on baseline data. Inclusion criteria (≥1500 births/year, comprehensive obstetric care, readiness assessment) are clearly defined. Outlier handling is not explicitly discussed, but the intention-to-treat analysis and generalized linear mixed model approach pre-specified in the protocol are appropriate. The trial includes a baseline control phase which serves as its own control. Independent replication was not part of this single trial, but the consistency across countries and facility size supports generalizability.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsINADEQUATE

outlier handlingNOT REPORTED

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study design is robust with randomization, a power analysis, and intention-to-treat analysis; however, outlier handling is not explicitly reported.

Evidence

direct quote[Methods, Trial design and oversight]

“A minimization algorithm generated by an independent statistician was used to ensure balance... A random element was incorporated so each facility was given the allocation that would minimize the imbalance with 90% probability, or the other allocation with 10% probability.”

direct quote[Methods, Statistical analysis]

“We calculated that at least 60 clusters... would be required for the trial to have 95% power, with 2 sided p < 0.05, to detect a 25% relative reduction in the composite primary outcome from 3% to 2.25%.”

direct quote[Methods, Statistical analysis]

“All analyses were performed according to the intention-to-treat principle.”

PASSReviewer 2· 95% conf

The trial design is rigorous: cluster-randomized with minimization, a baseline phase, pre-specified sample size calculation, and clearly defined inclusion/exclusion criteria. Blinding was not possible, but objective outcome definitions and adjudication mitigate bias.

Evidence

direct quote[Methods, Trial design and oversight, paragraph 1]

“A minimization algorithm generated by an independent statistician was used to ensure balance between facilities allocated to the intervention and control groups within each country.”

direct quote[Methods, Statistical analysis, paragraph 1]

“We calculated that at least 60 clusters (a minimum of 30 in Malawi and 30 in Uganda) would be required for the trial to have 95% power, with 2 sided p < 0.05, to detect a 25% relative reduction in the composite primary outcome from 3% to 2.25%.”

paraphrase[Methods, Outcome measures; Discussion, paragraph 3]

“The case classification committee was blinded to site allocation; study staff identifying outcomes were not blinded.”

PASSReviewer 3· 95% conf

The cluster-randomized design is rigorous with a minimization algorithm, a baseline control phase, and pre-specified sample-size calculations. Most applicable sub-criteria are reported and adequate for a human interventional trial.

Evidence

direct quote[Methods, paragraph 2]

“A minimization algorithm generated by an independent statistician was used to ensure balance between facilities allocated to the intervention and control groups within each country.”

direct quote[Statistical analysis, paragraph 1]

direct quote[Methods, Outcome measures, paragraph 1]

“If there was discordance in assessments, or if uncertainty in the causation was recorded by either group, the case was adjudicated by a separate case classification committee blinded to site allocation.”

All subjects are pregnant women (sex is female by definition). However, the paper does not report age, weight, or health status of participants. Demographics such as race/ethnicity are not reported. Only facility-level characteristics like number of births and resource availability are provided.

Sub-criteria

demographicsNOT REPORTED

sex reportedADEQUATE

sex justifiedN/A

age weight healthNOT REPORTED

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 85% conf

The study does not report age, weight, or other demographic characteristics of individual participants, only facility-level data.

Evidence

paraphrase[Methods, Participating hospitals]

“Women giving birth are the population, but individual sex is not reported.”

absence[Results, Table 1]

Age and health status of participants not reported.

absence[Results]

Demographics beyond country and facility type not reported.

PASSReviewer 2· 90% conf

The study population is well-characterized: sex is all female, age/parity may be available from baseline tables (not fully detailed in this text), and hospital-level characteristics are reported. Species/strain/housing are inapplicable, and demographics are partially reported.

Evidence

direct quote[Abstract]

“The primary outcome was a composite of maternal infection-related mortality or severe morbidity ... among pregnant or recently pregnant women.”

absence[Table 1]

Age or parity of individual women not reported in main text.

absence[Table 1]

Demographics such as race/ethnicity not reported.

WARNReviewer 3· 85% conf

Human demographics (age, sex, comorbidities) are not reported in the main paper, although all participants are pregnant/postpartum women. The paper omits key participant characteristics beyond obstetric outcomes and resource availability.

Evidence

absence[Results, Hospital and participant characteristics; Table 1]

All participants are pregnant/postpartum women, so sex is reported, but no age or comorbidity data appear in the manuscript tables.

direct quote[Table 1]

“Characteristics of participating facilities and resource availability at baseline”

paraphrase[Methods, Trial design]

“The trial population is defined as pregnant or recently pregnant women.”

The paper lists ethics committees that approved the trial, including institutional and national bodies. Informed consent was waived with justification (intervention delivered to providers, components considered best practice). However, no explicit statement of compliance with the Declaration of Helsinki or other regulations is provided, making regulatory_compliance reported_but_inadequate.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceINADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 90% conf

Ethics approval from multiple committees is reported and a waiver of individual consent is justified, but explicit regulatory compliance statement is missing.

Evidence

direct quote[Methods, Trial design and oversight]

“The trial was approved by the University of Liverpool, the WHO Ethics Review Committee, the College of Medicine Research Ethics Committee in Malawi, the Infectious Diseases Institute Research Ethics Committee and Uganda National Council for Science and Technology in Uganda.”

direct quote[Methods, Trial design and oversight]

“Patients were not individually consented as the intervention was delivered to healthcare providers, and the components were considered best practice.”

absence[Methods]

No explicit regulatory compliance statement (e.g., Declaration of Helsinki).

WARNReviewer 2· 90% conf

Ethics committee approval is reported, but informed consent is addressed with a waiver justification; however, the justification for waiving individual consent is borderline and may be considered inadequate for a trial generating non-public subject-level data (clinical outcomes).

Evidence

direct quote[Methods, Trial design and oversight, paragraph 2]

“Patients were not individually consented as the intervention was delivered to healthcare providers, and the components were considered best practice.”

absence[Methods, Trial design and oversight]

Regulatory compliance not explicitly named.

PASSReviewer 3· 95% conf

Ethics approval from multiple named bodies is stated, informed consent was waived with a justification, and regulatory compliance (Declaration of Helsinki) is implied via WHO approval. All applicable criteria are adequately reported.

Evidence

direct quote[Methods, Trial design and oversight, paragraph 3]

“Patients were not individually consented as the intervention was delivered to healthcare providers, and the components were considered best practice.”

absence[Methods, Trial design and oversight]

No explicit statement of adherence to a named regulatory framework (e.g., Declaration of Helsinki).

The study is a clinical trial of a multicomponent behavioral and systems intervention, not a drug. The 'investigational product' is the intervention itself, which is described in Figure 1 and text. Antibiotics (ceftriaxone, metronidazole, gentamicin) are named as part of the FAST-M bundle, but no manufacturer, lot numbers, or concentrations are given (inadequate). The observation chart and checklists are described but not provided with RRIDs or full specifications. Software tools (e.g., for analysis) are not identified in the main text (likely SAS/Stata/R, but not stated). The trial protocol may contain more detail. This is a human interventional trial, so antibodies, cell lines, mycoplasma, organisms are not applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedINADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedNOT REPORTED

Per reviewer (3) — the votes behind the verdict

N/AReviewer 1· 95% conf

The study is a behavioral/system intervention without a drug, biologic, or device as an investigational product, and no wet-lab reagents were used, making this dimension not applicable.

Evidence

paraphrase[Methods, APT-Sepsis intervention and usual care]

“The intervention is a multi-component program including hand hygiene, infection prevention, and sepsis bundle, not a specific product.”

WARNReviewer 2· 85% conf

The investigational product is the APT-Sepsis program, which is described in detail, but key resources such as antibiotics are only mentioned generically (ceftriaxone, metronidazole, gentamicin) without lot numbers or full identification. Software is not versioned in the main text.

Evidence

direct quote[Figure 1]

“Antibiotics - According to source or if unknown ceftriaxone 2g IV OD and metronidazole 500mg IV TDS (or 400mg PO TDS) with additional singe dose gentamicin 5mg/kg IV if haemodynamically unstable.”

absence[Methods, Statistical analysis]

Statistical software not identified.

PASSReviewer 3· 80% conf

The intervention is a multicomponent program with behavior change strategies and relatively few additional resources; the investigational 'product' is the program itself plus standard drugs/resources, which are adequately identified. Software for analysis is identified. Antibodies, cell lines, and organisms are not applicable.

Evidence

direct quote[Methods, APT-Sepsis intervention and usual care; Figure 1]

“FAST-M bundle: To be completed within 1 hour. Fluids - 500ml crystalloid bolus, repeated if hypotension persists. Antibiotics - According to source or if unknown ceftriaxone 2g IV OD and metronidazole 500mg IV TDS (or 400mg PO TDS) with additional singe dose gentamicin 5mg/kg IV if haemodynamically unstable.”

direct quote[Methods, Trial design and oversight, paragraph 4]

“The first and last author, and the trial statisticians from the Liverpool Clinical Trials Centre vouch for the accuracy and completeness of the data and for the fidelity of the trial to the protocol, available with the full text of this article at NEJM.org.”

paraphrase[Methods, APT-Sepsis intervention and usual care]

“Key resources such as antibiotics were obtained by both the intervention and control sites through their usual procurement pathways.”

The primary analysis method (generalized linear mixed effects model with logit link and robust SEs) is named and justified. Exact p-values are reported (P<0.001 for primary). Effect sizes (risk ratios, mean differences) and 95% confidence intervals are provided throughout. Assumptions such as normality are not mentioned, but the model is robust to misspecification. Software is not identified. Data presentation includes detailed tables (Table 2) with counts, percentages, and denominators. Redundant checking: several percentages can be verified (e.g., 1752/124298 = 0.01409, rounds to 1.4% — consistent). No arithmetic inconsistencies were detected.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedNOT REPORTED

assumptions verifiedNOT REPORTED

mathematical plausibilityPASS

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 80% conf

Statistical methods are appropriate and effect sizes with CIs are reported, but software is not identified, model assumptions are not verified, and exact p-values are not provided for secondary outcomes.

Evidence

direct quote[Methods, Statistical analysis]

“We used generalized linear mixed effects models incorporating a constrained baseline approach... with robust standard errors, followed by marginal standardization to estimate risk ratios and risk differences.”

direct quote[Results, Outcomes]

“risk ratio, 0.68; 95% CI, 0.55 to 0.83; P<0.001”

absence[Methods, Statistical analysis]

Statistical software not identified.

PASSReviewer 2· 90% conf

Statistical methods are well-described: tests named (generalized linear mixed model with binomial link, marginal standardization), pre-specified subgroups, and exact p-values reported. Effect sizes with CIs are given. Assumption verification is not explicitly reported but is reasonable for a trial using robust SEs and mixed models. Data presentation includes tables with counts and percentages, and figures with confidence intervals.

Evidence

direct quote[Methods, Statistical analysis, paragraph 2]

“We used generalized linear mixed effects models incorporating a constrained baseline approach. ... We used binomial distribution and logit link, with robust standard errors, followed by marginal standardization to estimate risk ratios and risk differences.”

direct quote[Results, Outcomes, paragraph 1]

“risk ratio, 0.68; 95% CI, 0.55 to 0.83; P<0.001”

paraphrase[Table 2]

“Table 2 provides for each outcome the count, denominator, percentage, and risk ratio or mean difference with 95% CI.”

PASSReviewer 3· 90% conf

The analysis methods are appropriate for a cluster-randomized trial, pre-specified, and include both primary and subgroup analyses. Exact p-values and confidence intervals are reported for the primary outcome; secondary outcomes have CIs but no multiplicity adjustment is noted. Data presentation is adequate for a large trial.

Evidence

direct quote[Methods, Statistical analysis, paragraph 2]

“In the primary analysis, we used generalized linear mixed effects models incorporating a constrained baseline approach.”

direct quote[Results, Outcomes, paragraph 1; Table 2 footnote]

“P<0.001”

absence[Methods, Statistical analysis]

Analysis software not explicitly named in the methods.

The paper mentions the protocol is available with the full text at NEJM.org, which may include a data sharing plan, but no standalone data availability statement or repository accession number is given in the manuscript. The ISRCTN registration is provided, which typically includes a data sharing statement, but that is not part of the manuscript text. Code is not mentioned. For a clinical trial of this scale, a data sharing statement (e.g., managed access via a repository) is expected.

Sub-criteria

code sharingNOT REPORTED

accession numbersN/A

repository depositN/A

data availability statementNOT REPORTED

Per reviewer (3) — the votes behind the verdict

FAILReviewer 1· 90% conf

No data availability statement or data repository deposit is reported; the protocol is available but data and code are not.

Evidence

absence[End of article]

No data availability statement.

direct quote[Methods, Trial design and oversight]

WARNReviewer 2· 90% conf

The paper states that data are available with the full text at NEJM.org and a protocol is referenced, but no explicit data availability statement (e.g., repository deposition or managed access) is provided. The trial is registered (ISRCTN42347014). Code is not shared.

Evidence

absence[End of manuscript]

No explicit data availability statement in the manuscript.

direct quote[Abstract; Disclosure forms]

“APT-Sepsis ISRCTN number, ISRCTN42347014.”

WARNReviewer 3· 90% conf

A data availability statement is present and adequate (protocol available at NEJM.org), but there is no mention of a permanent repository for the individual patient data, and no code sharing is reported. Only the data_availability_statement is adequate; repository_deposit and code_sharing are inadequate for a contemporary trial.

Evidence

direct quote[Methods, Trial design and oversight, paragraph 4]

absence[Methods, Trial design and oversight]

No mention of a data repository or managed-access platform for the individual patient data.

absence[Entire paper]

No code sharing repository or statement is provided.

The methods are detailed enough for replication. The trial is registered (ISRCTN42347014). All outcomes appear reported. Limitations are discussed. Conclusions are proportional. Funding and conflicts are disclosed. However, no explicit reference to a reporting guideline like CONSORT is made.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Reporting is complete and transparent; methods, outcomes, limitations, and funding are well described, though a reporting guideline checklist is not referenced.

Evidence

direct quote[Abstract]

“APT-Sepsis ISRCTN number, ISRCTN42347014.”

direct quote[Discussion]

“The trial has several limitations. The multicomponent nature of the intervention precludes attribution of the effect to individual elements.”

absence[Methods]

No reporting guideline checklist referenced.

PASSReviewer 2· 90% conf

The manuscript is well-reported: methods are detailed, limitations are discussed, conclusions are proportional, funding and COI are provided, and the trial is registered.

Evidence

direct quote[Abstract; Disclosure forms]

“APT-Sepsis ISRCTN number, ISRCTN42347014.”

direct quote[Discussion, paragraph 3]

“The multicomponent nature of the intervention precludes attribution of the effect to individual elements. ... As study staff identifying outcomes were not blinded to group allocation, and there is subjectivity in identifying the relatedness of outcomes to infection, bias is possible.”

paraphrase[Table 2]

“Table 2 reports secondary outcomes such as stillbirth and neonatal death which did not reach statistical significance.”

PASSReviewer 3· 90% conf

The trial is registered (ISRCTN42347014), methods are described in sufficient detail for replication, limitations are discussed, conclusions are proportional, and funding/COI disclosures are provided. The CONSORT reporting guideline is not explicitly referenced, but the paper follows its structure.

Evidence

direct quote[Abstract]

“(Funded by the Joint Global Health Trials scheme and others; APT-Sepsis ISRCTN number, ISRCTN42347014.)”

direct quote[Discussion, paragraph 4]

“The multicomponent nature of the intervention precludes attribution of the effect to individual elements. Microbiological data were not available, preventing pathogen-specific diagnosis or resistance profiling. As study staff identifying outcomes were not blinded to group allocation, and there is subjectivity in identifying the relatedness of outcomes to infection, bias is possible.”

absence[Methods]

No CONSORT or other reporting guideline is referenced.

3 copyedit issues flagged: mostly typo, other.

Checked 30 references: 21 verified — 9 not checked.

Reproducibility

1 data/code link checked; 0 live.

Registered (1 ID: ISRCTN). No reporting guideline cited.

Adcurare Rigor Action ItemsFinal pass before journal submission

The paper is nearly submission-ready but requires several reporting additions before submission. The most critical gap is the absence of a data availability statement, which major journals now require. Adding participant demographics, software identification, a regulatory compliance statement, and a CONSORT checklist will address the remaining reviewer concerns.

1.
HIGHdata code
Add a data availability statement at the end of the manuscript specifying how individual patient data can be accessed (e.g., via a managed-access platform or data-access committee), as per ICMJE and journal requirements.
Major journals require a data availability statement; its absence is a likely rejection/return issue.
2.
HIGHreporting
In Table 1 (Results), report baseline demographics for participants: age, parity, HIV status, and other relevant health characteristics, for each arm.
Participant-level demographics are essential to assess balance and potential confounders in a large trial.
3.
HIGHstatistics
In the Methods Statistical analysis section, identify the statistical software used (e.g., SAS version 9.4, Stata 17, or R version 4.x) with the specific package and version.
Software identification is required for reproducibility; its absence is a common reviewer request.
4.
HIGHethics
In the Methods Trial design and oversight section, add an explicit statement of regulatory compliance, e.g., 'The trial was conducted in accordance with the Declaration of Helsinki and ICH-GCP guidelines.'
Explicit compliance statements are expected by journals and ethics reviewers.
5.
HIGHreporting
In the Methods, cite the CONSORT extension for cluster-randomized trials and include a completed CONSORT checklist as a supplementary file.
Reporting guideline checklists are increasingly required by journals and improve completeness.
6.
HIGHother
In the Methods Statistical analysis section, add a brief statement on how missing data and outliers were handled (e.g., no data were excluded, or specify the method).
Handling of missing data and outliers is a standard reporting expectation for clinical trials.
7.
MEDIUMstatistics
In the Methods Statistical analysis section, describe how model assumptions (e.g., linearity, overdispersion) were verified for the generalized linear mixed models.
Verification of assumptions, even if robust standard errors are used, strengthens methodological transparency.
8.
MEDIUMdata code
Provide the custom analysis code in a public repository (e.g., GitHub, Zenodo) with a persistent DOI, and include a code availability statement in the manuscript.
Code sharing enables full reproducibility and is increasingly expected by journals.
9.
LOWcopyedit
Fix the typo in Figure 1: change 'singe dose gentamicin' to 'single dose gentamicin'.
Typographical errors, even minor, should be corrected before submission.
10.
LOWcopyedit
Rephrase the sentence in Methods, Trial design and oversight: 'Facilities were allocated sequentially. With 90% probability, each facility received the allocation that would minimize imbalance, and with 10% probability, the other allocation.'
The original phrasing is slightly unclear; this revision improves readability.

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A Multicomponent Intervention to Improve Maternal Infection Outcomes.

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DOI

10.1056/NEJMoa2512698

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