Rigor Reviewed

Rigor-Reviewed Manuscript

Prophylactic tranexamic acid for the prevention of postpartum haemorrhage in women with placenta praevia: multicentre, double blind, randomised, placebo controlled, phase 3 trial.

Name: Adcurare Rigor Record — Prophylactic tranexamic acid for the prevention of postpartum haemorrhage in women with placenta praevia: multicentre, double blind, randomised, placebo controlled, phase 3 trial.
Item: Prophylactic tranexamic acid for the prevention of postpartum haemorrhage in women with placenta praevia: multicentre, double blind, randomised, placebo controlled, phase 3 trial.
Rating: 96
Author: Adcurare

Zhang L, Bi S, Chen L, Du L, He F, Qiao Y, Li Z, Zeng W, Zhao X, Chen X, Li X, Ding G, Zhou W, Sun B, Guo Q, Guo X, Jin F, Wang X, Zhu Q, Sun Q, Jiang S, Wang X, Cai F, Jiang Y, Gao J, Wang Z, Wang Z, Zhang L, Liu JM, Huang L, Yu L, Chen J, Zhang S, Poon LC, Li HT, Chen D, study’s collaborator group

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Adcurare Rigor Review — 4.75★ (Strong), 0 critical, 4 high issues for “Prophylactic tranexamic acid for the prevention of postpartum haemorrhage in women with placenta praevia: multicentre, double blind, randomised, placebo controlled, phase 3 trial.”

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Adcurare Editorial

This rigor review was examined and confirmed by Adcurare Editorial · July 6, 2026

Adcurare Rigor Review

Rigor Reviewed

4.75 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

ReportingData & code availability partially met−0.25★

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

Problems surfaced1 type

Data/code availability incomplete

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 paper presents a well-designed, rigorously conducted phase 3 trial with strong methodological reporting in most dimensions. The main weaknesses are the absence of an explicit regulatory compliance statement in the ethics section and the use of a GitHub repository without a persistent identifier for data and code sharing.

All eight dimensions were applicable and evaluated. The three independent reviewers largely agreed, with minor divergence on ethical approvals (pass vs. warn) resolved by weighing the evidence. The statistics verification component checked 7 tests, all consistent; coverage is limited to tests with a test statistic and df or an effect estimate with CI. The citation check found no retracted or not-found references.

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

Recomputed 7 tests: 7 consistent, 0 inconsistent, 7 via agent-written checks.

Reporting

Eight Dimensions7 pass · 1 warn

The introduction cites prior research establishing that postpartum haemorrhage is a leading cause of maternal death, that placenta praevia increases risk, and that tranexamic acid reduces haemorrhage in low-risk caesarean deliveries. It explicitly states the gap: 'no evidence exists for tranexamic acid reducing more severe maternal outcomes' and 'previous studies have predominantly enrolled participants from low risk or mixed risk populations'. The rationale logically links this gap to the study's objective. Limitations of prior research (selective enrolment, lack of high-risk data) are acknowledged and addressed by the study design.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The paper clearly establishes the scientific premise by citing prior work on postpartum haemorrhage, placenta praevia, and tranexamic acid, and identifies a gap in evidence for high-risk populations.

Evidence

direct quote[Introduction, paragraphs 1-3]

“Tranexamic acid, an antifibrinolytic agent that inhibits plasmin mediated fibrinolysis, has been shown to effectively reduce the incidence of postpartum haemorrhage during caesarean delivery in low risk populations.”

direct quote[Introduction, paragraph 3]

“Notably, previous studies have predominantly enrolled participants from low risk or mixed risk (∼50% unscheduled caesarean delivery) populations. Such selective enrolment has left a critical gap in prophylactic use of tranexamic acid in high risk patients”

direct quote[Introduction, paragraph 3]

“Therefore, we conducted a randomised, double blind, placebo controlled trial to investigate whether tranexamic acid could reduce the incidence of postpartum haemorrhage without increasing the risk of adverse events in women with placenta praevia undergoing caesarean delivery.”

PASSReviewer 2· 95% conf

The paper establishes a clear scientific premise by citing prior research on postpartum hemorrhage and tranexamic acid, and identifies a gap in high-risk populations.

Evidence

paraphrase[Introduction, paragraphs 1-2]

“The Introduction describes postpartum hemorrhage as a leading cause of maternal mortality, the association with placenta praevia (incidence ~1/3), and the increasing prevalence in China, citing multiple references.”

direct quote[Introduction, paragraph 3]

“Notably, previous studies have predominantly enrolled participants from low risk or mixed risk (~50% unscheduled caesarean delivery) populations. Such selective enrolment has left a critical gap in prophylactic use of tranexamic acid in high risk patients.”

direct quote[Introduction, final sentence]

PASSReviewer 3· 95% conf

The paper clearly establishes the scientific foundation by citing prior research on postpartum haemorrhage and placenta praevia, identifying gaps in evidence for high-risk populations, and providing a logical rationale for the trial.

Evidence

direct quote[Introduction, paragraph 2]

“previous studies have predominantly enrolled participants from low risk or mixed risk (~50% unscheduled caesarean delivery) populations”

Randomization uses a centralised computer-generated sequence with block size six and stratification by site, maternal age, and placenta praevia type. Blinding covers participants, investigators, clinical staff, sponsor, and data analysts. A priori power analysis (80% power, 5% alpha, 20% relative risk reduction) is provided with attrition adjustment. Inclusion and exclusion criteria are clearly listed; the analysis population (ITT with exclusions for consent withdrawal and ineligibility) is defined. Outlier handling is addressed through sensitivity analyses and per-protocol population.

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

The study design is rigorous: centralised computer-generated randomisation with stratification, double-blinding, a priori power analysis, pre-specified inclusion/exclusion criteria, and appropriate controls. Blinding and randomisation are well described.

Evidence

direct quote[Methods, Randomisation and masking]

“Study investigators randomly assigned patients in a 1:1 ratio using a centralised computer generated randomisation (Sun Yat-sen University Cancer Centre, Guangzhou, China) with a block size of six to receive either tranexamic acid or placebo. Randomisation was stratified according to the study site, maternal age group (≥35 or <35 years), and placenta praevia type (low lying placenta or placenta praevia).”

direct quote[Methods, Randomisation and masking]

“Participants, investigators, clinical staff, the study sponsor, and the data analysts were masked to treatment assignment.”

direct quote[Methods, Sample size calculation]

“To achieve 80% power in detecting a ≥20% relative difference in incidence (33% in the placebo group versus 26.4% in the tranexamic acid group) at a two sided type I error rate of 5%, the required sample size was determined to be 1500 (750 in each group) based on a standard two sample test for comparing proportions. To account for a projected 10% attrition rate... the final sample size was set at 840 women in each treatment arm, totalling 1680 participants.”

PASSReviewer 2· 95% conf

The trial design is rigorous: centralized computer-generated randomization with concealment, double-blinding, a pre-specified power analysis with attrition, explicit inclusion/exclusion criteria, and a defined analysis population.

Evidence

direct quote[Methods: Randomisation and masking, paragraph 1]

direct quote[Methods: Randomisation and masking, final sentence]

“Participants, investigators, clinical staff, the study sponsor, and the data analysts were masked to treatment assignment.”

direct quote[Methods: Sample size calculation]

“To achieve 80% power in detecting a ≥20% relative difference in incidence (33% in the placebo group versus 26.4% in the tranexamic acid group) at a two sided type I error rate of 5%, the required sample size was determined to be 1500 (750 in each group)... To account for a projected 10% attrition rate... the final sample size was set at 840 women in each treatment arm, totalling 1680 participants.”

PASSReviewer 3· 98% conf

The trial design is rigorously described with adequate randomization, blinding, sample size justification, and pre-specified inclusion/exclusion criteria.

Evidence

direct quote[Methods, Randomisation and masking]

“Participants, investigators, clinical staff, the study sponsor, and the data analysts were masked to treatment assignment”

direct quote[Methods, Sample size calculation]

Sex is reported (all female, as the condition is exclusive to pregnant women), and a scientific justification is inherent (placenta praevia only occurs in pregnancy). Age, BMI, and health status (e.g., diabetes, hypertensive disorders) are reported in Table 1. Demographics are extensive: age, BMI, education, mode of conception, parity, number of previous caesarean deliveries, gestational age, and comorbidities. Species/strain/source and housing conditions are not applicable for a human trial.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedADEQUATE

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Biological variables relevant to a human trial are well reported: sex (all female, justified by condition), age, BMI, health status, and detailed demographics including education, mode of conception, parity, and comorbidities.

Evidence

direct quote[Abstract, Methods, Table 1]

“1732 women with placenta praevia undergoing caesarean delivery.”

direct quote[Table 1]

“Mean (SD) age (years): 33.8 (4.3) [tranexamic acid] vs 34.0 (4.4) [placebo]; Mean (SD) BMI: 22.1 (3.5) vs 22.2 (3.6)”

direct quote[Table 1]

“Education: Master’s degree, Bachelor’s degree, High school or below, Unknown; Mode of conception: Natural conception, Artificial insemination, IVF/ICSI; Primiparous; No of previous caesarean deliveries; Gestational/prepregnancy diabetes; Gestational hypertensive disorders”

PASSReviewer 2· 95% conf

Biological variables are comprehensively reported: sex is exclusively female (justified by the condition), age, BMI, and health status are tabulated, and human demographics (age, education, parity, etc.) are provided.

Evidence

direct quote[Abstract, Methods: Participants]

“Participants: 1732 women with placenta praevia undergoing caesarean delivery.”

direct quote[Results, Table 1]

“Table 1 Baseline characteristics... Mean (SD) age (years): 33.8 (4.3) [tranexamic acid group]... Mean (SD) BMI: 22.1 (3.5)... haemoglobin level >90 g/L within the preceding week (inclusion criterion).”

direct quote[Results, Table 1]

“Education: Master’s degree 28 (3.3)... Primiparous: 133 (15.7)... Gestational/prepregnancy diabetes: 229 (27.1)...”

PASSReviewer 3· 95% conf

Subject characteristics are comprehensively reported in Table 1, including age, BMI, health status, and demographics. The single-sex design is inherent to the condition and requires no further justification.

Evidence

direct quote[Table 1 and Abstract]

“women with placenta praevia”

direct quote[Table 1]

“Mean (SD) age (years) | 33.8 (4.3) | 34.0 (4.4) | Mean (SD) BMI | 22.1 (3.5) | 22.2 (3.6) |”

paraphrase[Table 1]

“Table 1 includes education level, mode of conception, parity, number of previous caesarean deliveries, and other relevant characteristics.”

The trial was approved by the Clinical Research and Applied Ethics Committee of The Third Affiliated Hospital, Guangzhou Medical University on 30 May 2023 (ethics review No 045). Written informed consent was obtained from all patients or their legally authorised representatives. Compliance with the Declaration of Helsinki is not explicitly stated, but the ethics approval process and the statement that the trial was conducted in accordance with ethical principles (implied by the approval) are sufficient. The paper also states that ethical approval from other participating centres was obtained before patient enrolment.

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 approval from a named ethics committee with a protocol number is reported, written informed consent was obtained, and compliance with the Declaration of Helsinki is implied through the approval process.

Evidence

direct quote[Ethics statements]

“The trial was approved the Clinical Research and Applied Ethics Committee of The Third Affiliated Hospital, Guangzhou Medical University on 30 May 2023 (ethics review No 045).”

direct quote[Ethics statements]

“All patients or their legally authorised representatives (ie, spouse or parents) provided written informed consent before randomisation.”

direct quote[Ethics statements]

“Ethical approval from the other participating centres was obtained before patient enrolment.”

PASSReviewer 2· 90% conf

Ethical approval by a named committee (including protocol number) and written informed consent from all participants are explicitly reported; regulatory compliance is implied via adherence to Chinese guidelines and international standards, and the trial is registered.

Evidence

direct quote[Ethics statements]

“The trial was approved the Clinical Research and Applied Ethics Committee of The Third Affiliated Hospital, Guangzhou Medical University on 30 May 2023 (ethics review No 045).”

direct quote[Methods: Participants, final sentence]

“Eligible patients received information on the trial from trained clinical staff and provided written informed consent.”

direct quote[Methods: Procedures]

“Standardised protocols and uniform training were implemented... designed to adhere to Chinese guidelines and institutional protocols, while remaining aligned with international standards.”

WARNReviewer 3· 88% conf

Ethics approval is named with a protocol number and informed consent is documented, but the paper does not include an explicit statement of compliance with a recognized regulatory framework such as the Declaration of Helsinki.

Evidence

direct quote[Ethics statements]

“The trial was approved the Clinical Research and Applied Ethics Committee of The Third Affiliated Hospital, Guangzhou Medical University on 30 May 2023 (ethics review No 045).”

direct quote[Methods, Participants]

“All patients or their legally authorised representatives (ie, spouse or parents) provided written informed consent before randomisation.”

absence[Ethics statements and Methods]

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

Tranexamic acid (Chengdu Lier Pharmaceutical) and placebo (Hebei Tiancheng Pharmaceutical) are named with location; dose and preparation are described. The statistical software R version 4.4.3 is identified. No antibodies, cell lines, or organisms are used. Therefore, all applicable sub-criteria are adequate.

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

PASSReviewer 1· 90% conf

The investigational product (tranexamic acid and placebo) is identified with manufacturer and formulation. Statistical software is identified. No antibodies, cell lines, or organisms are used, so those criteria are not applicable.

Evidence

direct quote[Methods, Randomisation and masking]

“tranexamic acid (Chengdu Lier Pharmaceutical, Dujiangyan, Sichuan, China) and placebo (Hebei Tiancheng Pharmaceutical, Cangzhou, Hebei, China)”

direct quote[Methods, Statistical analysis]

“All statistical analyses were performed using R version 4.4.3.”

PASSReviewer 2· 85% conf

The investigational product (tranexamic acid and placebo) is identified with manufacturer, but not full formulation details (e.g., lot numbers) beyond dose/volume. Software is identified with version. Wet-lab resources are not applicable.

Evidence

direct quote[Methods: Randomisation and masking]

“...tranexamic acid (Chengdu Lier Pharmaceutical, Dujiangyan, Sichuan, China) and placebo (Hebei Tiancheng Pharmaceutical, Cangzhou, Hebei, China).”

direct quote[Methods: Statistical analysis, final sentence]

“All statistical analyses were performed using R version 4.4.3.”

PASSReviewer 3· 95% conf

The investigational products (tranexamic acid and placebo) are identified with manufacturer and source, and the statistical software is specified with version. No other key biological resources apply.

Evidence

direct quote[Methods, Randomisation and masking]

“tranexamic acid (Chengdu Lier Pharmaceutical, Dujiangyan, Sichuan, China) and placebo (Hebei Tiancheng Pharmaceutical, Cangzhou, Hebei, China)”

direct quote[Methods, Statistical analysis]

“All statistical analyses were performed using R version 4.4.3.”

Primary analysis uses log-binomial mixed effects regression; sensitivity and subgroup analyses are clearly defined. Exact p-value (P=0.01) is given for the primary outcome with 95.2% CI. Secondary outcomes present CIs; exact p-values are not always provided, which is a minor shortfall but does not affect the overall pass. Software is identified. Data presentation includes per-group N, percentages, and CIs, typical for a large trial.

Sub-criteria

tests namedADEQUATE

exact p valuesINADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical tests are named, exact p-values are reported, effect sizes with confidence intervals are provided, software is identified, and data presentation includes per-group n and appropriate measures. Assumptions are handled through the use of mixed-effects models, and mathematical plausibility checks are not applicable for continuous outcomes with large N.

Evidence

direct quote[Methods, Statistical analysis; Results, Primary outcome]

“For binary outcomes, we used log-binomial mixed effects regression models with study centre as a random effect... The primary outcome occurred in 29.7% (251/845) of the tranexamic acid group and 35.1% (297/846) of the placebo group (relative risk 0.85, 95.2% confidence interval (CI) 0.75 to 0.96; P=0.01).”

direct quote[Table 2]

“Relative risk (95% CI)* ... 0.85 (0.75 to 0.96)§”

direct quote[Methods, Statistical analysis]

“All statistical analyses were performed using R version 4.4.3.”

PASSReviewer 2· 90% conf

Statistical tests are named (log-binomial mixed effects, modified Poisson, linear mixed effects), software is identified, exact p-values are reported, and effect sizes with CIs are provided. Data presentation includes per-group n and CIs. Assumptions verification is not explicitly reported, but the use of mixed effects models and robust standard errors is acceptable for a clinical trial.

Evidence

direct quote[Methods: Statistical analysis, paragraph 1]

“For binary outcomes, we used log-binomial mixed effects regression models with study centre as a random effect, adjusting for maternal age group and placenta praevia type, to estimate relative risks with 95% confidence intervals.”

direct quote[Results: Primary outcome, paragraph 1]

“Postpartum haemorrhage occurred in 251 of 845 participants (29.7%) in the tranexamic acid group and 297 of 846 (35.1%) in the placebo group (relative risk 0.85, 95.2% CI 0.75 to 0.96; P=0.01).”

paraphrase[Methods: Statistical analysis]

“The paper describes the use of log-binomial mixed effects models and, when convergence fails, modified Poisson regression with robust sandwich standard errors, but does not state that normality or equal variance assumptions were tested.”

PASSReviewer 3· 92% conf

Statistical methods are appropriate and well-described; exact p-values are provided for the primary outcome, and effect sizes with confidence intervals are reported throughout. The analysis is plausible and reproducible.

Evidence

direct quote[Methods, Statistical analysis]

“For binary outcomes, we used log-binomial mixed effects regression models with study centre as a random effect”

direct quote[Abstract and Results]

“P=0.01”

direct quote[Table 2]

“Relative risk (0.85, 95.2% CI 0.75 to 0.96)”

The data availability statement says 'The data underlying the findings in this paper are openly and publicly available and can be found at https://github.com/ChenDunjin-GZHMU'. This GitHub link appears to be a code repository, not a dedicated data repository with a persistent identifier. The statement is vague about the data format and does not provide a DOI or accession number. The code is shared in the supplementary file, which is adequate for code sharing. No repository deposit or accession numbers are provided for the data.

Sub-criteria

code sharingADEQUATE

accession numbersN/A

repository depositNOT REPORTED

data availability statementINADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 85% conf

A data availability statement is present, but it is vague ('openly and publicly available' with a GitHub link that appears to be a code repository, not a data repository). The code is shared in the supplementary file, but the data access route is not concrete.

Evidence

direct quote[Data availability statement]

“The data underlying the findings in this paper are openly and publicly available and can be found at https://github.com/ChenDunjin-GZHMU . The corresponding author can be contacted if there are problems accessing the data.”

direct quote[Data availability statement]

“The code used to analyse the data in the paper are in the supplementary file.”

WARNReviewer 2· 85% conf

A data availability statement is present and links to a GitHub repository, but its content (code only, data via the same URL) is ambiguous. The code is shared in supplementary files and GitHub, but the data are promised 'openly and publicly available' at a GitHub repo, which is not a typical data repository with a persistent identifier.

Evidence

direct quote[Data availability statement]

“The code used to analyse the data in the paper are in the supplementary file. The data underlying the findings in this paper are openly and publicly available and can be found at https://github.com/ChenDunjin-GZHMU .”

paraphrase[Data availability statement]

“The statement mentions code in the supplementary file and on GitHub, but no DOI or version-controlled release is specified.”

WARNReviewer 3· 85% conf

A data availability statement is present and points to a GitHub repository, but the repository lacks a persistent identifier (DOI) and the code is shared only in the supplementary file, not in a version-controlled public repository with a permanent identifier.

Evidence

direct quote[Data availability statement]

“The data underlying the findings in this paper are openly and publicly available and can be found at https://github.com/ChenDunjin-GZHMU”

direct quote[Data availability statement]

“The code used to analyse the data in the paper are in the supplementary file.”

The trial is registered at ClinicalTrials.gov (NCT05811676). Methods are detailed enough for replication, including randomisation, blinding, procedures, and statistical analysis. Limitations are explicitly discussed (generalisability, multiple comparisons, recall bias, single-country setting). Conclusions are proportional: 'statistically significant yet modest reduction' and no overclaiming of causation. Funding sources and competing interests are reported. A reporting guideline (CONSORT) is not explicitly referenced, but the paper follows a standard clinical trial reporting structure.

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· 95% conf

The trial is registered (NCT05811676), methods are detailed, limitations are discussed, conclusions are proportional, and funding/COI are reported. No reporting guideline is explicitly referenced, but the paper follows CONSORT-like structure.

Evidence

direct quote[Abstract]

“Trial registration ClinicalTrials.gov NCT05811676 .”

direct quote[Discussion, Strengths and limitations of this study]

“The main limitation of this study was that, despite intending to systematically record all ineligible women and reasons for exclusion, comprehensive data collection was not feasible owing to practical constraints during the trial.”

direct quote[Funding and Competing interests sections]

“Funding: This work was supported by the National Key Research and Development Program of China (grant No 2022YFC2704500 and 2022YFC2704501)... Competing interests: All authors have completed the ICMJE uniform disclosure form... and declare: support from the National Key Research and Development Program of China... no financial relationships with any organisations...”

PASSReviewer 2· 90% conf

The paper is transparent: trial registration is provided, methods are detailed, limitations are discussed, conclusions are proportional, outcomes are reported, and funding/competing interests are declared. However, no reporting guideline checklist (e.g., CONSORT) is explicitly referenced.

Evidence

direct quote[Abstract, trial registration]

“Trial registration ClinicalTrials.gov NCT05811676 .”

direct quote[Discussion: Strengths and limitations of this study]

absence[Methods and Results sections]

No explicit mention of a reporting guideline checklist.

PASSReviewer 3· 93% conf

The manuscript is well-structured with detailed methods, trial registration, funding disclosure, and limitations discussion. However, a reference to a reporting guideline (e.g., CONSORT) is missing.

Evidence

direct quote[Abstract]

“Trial registration ClinicalTrials.gov NCT05811676”

paraphrase[Funding and Competing interests sections]

“Funding sources are listed with grant numbers; competing interests are declared using ICMJE form.”

direct quote[Discussion]

“The main limitation of this study was that, despite intending to systematically record all ineligible women and reasons for exclusion, comprehensive data collection was not feasible”

10 copyedit issues flagged: mostly clarity, grammar, consistency.

Checked 26 references: 24 verified — 2 not checked.

Reproducibility

1 data/code link checked; 1 live.

Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.

Adcurare Rigor Action ItemsFinal pass before journal submission

The paper is ready to submit after minor edits. The two warn-level issues (missing regulatory compliance statement and inadequate data/code repository) are straightforward to fix and should be addressed before submission to avoid reviewer criticism.

1.
HIGHethics
Add an explicit statement of compliance with the Declaration of Helsinki and/or ICH-GCP guidelines in the Ethics statements section.
This is a standard requirement for human trials and its absence may be flagged by reviewers or editors.
2.
HIGHdata code
Deposit the de-identified dataset in a recognised archival repository (e.g., Dryad, Zenodo, Figshare) and obtain a DOI; update the data availability statement to reference the DOI.
A GitHub repository without a persistent identifier does not meet the standard for long-term data accessibility and may be rejected by the journal.
3.
HIGHdata code
Upload the analysis code to a version-controlled public repository (e.g., GitHub) integrated with Zenodo to obtain a DOI, and reference this DOI in the data availability statement.
Providing code in a supplementary file is not a version-controlled, citable repository; a DOI ensures permanent access and reproducibility.
4.
HIGHreporting
Explicitly cite the CONSORT reporting checklist in the Methods section and consider including a completed CONSORT checklist as a supplementary file.
Although the paper follows CONSORT structure, explicitly referencing the guideline is a standard transparency requirement for clinical trials.
5.
MEDIUMstatistics
Provide exact p-values for all key secondary outcomes in Table 2 or in a supplementary table.
Exact p-values (rather than thresholds) allow readers to assess the strength of evidence and are expected for all pre-specified outcomes.
6.
MEDIUMstatistics
Add a brief statement in the Statistical analysis section confirming that model assumptions (e.g., normality, homoscedasticity) were checked, or note that the mixed effects model with robust standard errors obviates this.
Explicit verification of assumptions strengthens the statistical reporting and addresses a common reviewer request.
7.
MEDIUMreporting
Clarify the notation for the number needed to treat for red cell transfusion in the Results section (e.g., '37 (number needed to harm, 92 to infinity, to number needed to benefit, 15)').
The current notation is confusing and may be misinterpreted by readers.
8.
MEDIUMreporting
Add a brief explanation for the 0.048 significance threshold (O'Brien-Fleming boundary) in the main text of the Statistical analysis section, not only in the context of the interim analysis.
Clarifying the adjusted threshold in the primary analysis section improves transparency and reader understanding.
9.
LOWcopyedit
Fix the subject-verb agreement error in the Data availability statement: change 'are' to 'is'.
Grammatical errors can detract from the professionalism of the manuscript.
10.
LOWcopyedit
Fix the missing preposition 'by' in the Ethics statements: change 'approved the Clinical Research...' to 'approved by the Clinical Research...'.
This grammatical error should be corrected for clarity.
11.
LOWcopyedit
Add a space after the closing parenthesis in the NNT sentence in the Results section: '...104)for postpartum...' should be '...104) for postpartum...'.
Minor formatting issue that improves readability.

Full text (63,742 chars)Analyzed: Jul 6, 2026

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Prophylactic tranexamic acid for the prevention of postpartum haemorrhage in women with placenta praevia: multicentre, double blind, randomised, placebo controlled, phase 3 trial.

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Journal

DOI

10.1136/bmj-2026-089636

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Issued Jul 6, 2026Engine 7.6.0

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