Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Efficacy of a single low dose of esketamine after childbirth for mothers with symptoms of prenatal depression: randomised clinical trial.

Name: Kaimen Rigor review — Efficacy of a single low dose of esketamine after childbirth for mothers with symptoms of prenatal depression: randomised clinical trial.
Item: Efficacy of a single low dose of esketamine after childbirth for mothers with symptoms of prenatal depression: randomised clinical trial.
Rating: 59
Author: Alpha1

Wang S, Deng CM, Zeng Y, Chen XZ, Li AY, Feng SW, Xu LL, Chen L, Yuan HM, Hu H, Yang T, Han T, Zhang HY, Jiang M, Sun XY, Guo HN, Sessler DI, Wang DX

Paper source

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Kaimen Rigor review — 2.75★ (Weak), 0 critical, 4 high issues for “Efficacy of a single low dose of esketamine after childbirth for mothers with symptoms of prenatal depression: randomised clinical trial.”

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Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 16, 2026

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Efficacy of a single low dose of esketamine after childbirth for mothers with symptoms of prenatal depression: randomised clinical trial.

Wang S, Deng CM, Zeng Y, Chen XZ, Li AY, Feng SW, Xu LL, Chen L, Yuan HM, Hu H, Yang T, Han T, Zhang HY, Jiang M, Sun XY, Guo HN, Sessler DI, Wang DX

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DOI

10.1136/bmj-2023-078218

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Efficacy of a single low dose of esketamine after childbirth for mothers with symptoms of prenatal depression: randomised clinical trial.

Wang S, Deng CM, Zeng Y, Chen XZ, Li AY, Feng SW, Xu LL, Chen L, Yuan HM, Hu H, Yang T, Han T, Zhang HY, Jiang M, Sun XY, Guo HN, Sessler DI, Wang DX

Paper source

Efficacy of a single low dose of esketamine after childbirth for mothers with symptoms of prenatal depression: randomised clinical 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 16, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

2.75 / 5

Weak — serious problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

CitationsCitations & links (capped) ×5−1★
IntegrityIntegrity concern−0.5★
ClaimsOverstated claim−0.5★
ReportingData & code availability partially met−0.25★

Citations & links are capped at −1★ combined, however many are flagged.

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 8 reported means were read, and their group size is not stated where the values are printed (this source has no machine-readable table structure). These checks need the count the mean was averaged over, so none was performed.
No data or code availability links were detected to verify.

Biggest issues

01Cites retracted work
highAvailabilityrecomputedFull detail
Retraction
“A Study on the Preventive Effect of Esketamine on Postpartum Depression (PPD) after Cesarean Section”
Reference 23Find in source
02Cites retracted work
highAvailabilityrecomputedFull detail
Marked retracted/withdrawn in the Crossref title.
“Efficacy and Safety of Esketamine for Supplemental Analgesia During Elective Cesarean Delivery: A Randomized Clinical Trial”
Reference 52Find in source
03Conclusion reaches beyond the evidence
mediumOverreachreviewer-assessedFull detail
The antidepressant effect of low dose esketamine lasts longer in mothers with prenatal depression than in the general population with depression.
“The antidepressant effect of low dose esketamine thus seems to last longer in mothers with prenatal depression than in the general population with depression.”
Discussion ¶1Find in source

Findings by category

101ArithmeticNumerical inconsistencies 102OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 205AvailabilityBroken references and links · partly checked 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.

This is a well-designed and rigorously reported randomized controlled trial of low-dose esketamine for postpartum depression prevention. The main methodological strengths are the robust randomization, blinding, sample size calculation, and transparent reporting. The primary weakness is the vague and incomplete data availability statement, which limits reproducibility.

Both reviewers independently scored all eight dimensions and agreed on every status, so no divergence needed reconciliation. The statistics verification recomputed only a subset of tests (6 reported with test statistics/CI) and found them consistent; this does not confirm the correctness of all analyses. The citation check flagged 2 retracted and 3 not-found references, which are addressed in the action items.

Numerical inconsistencies

1 finding · worst low

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.

Internal contradictions in the reported numbersAssessed

Recomputed 6 tests: 6 consistent, 0 inconsistent; 3 recomputed directly from the reported test statistics, 3 via agent-written checks.

Overstated conclusions

1 finding · worst medium

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 overstated beyond the evidenceAssessed

6 major claims checked against the paper's own evidence: 1 not fully backed by the presented evidence (unsupported or overstated).

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

Data authenticity concerns

None found

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.

Checked — nothing surfaced.

Reporting gaps

1 finding · worst medium

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.

Data/code availability incompleteAssessed

Eight Dimensions7 pass · 1 warn

Prior work is cited on perinatal depression prevalence, consequences, and the antidepressant effects of ketamine/esketamine. The authors note that previous trials were largely restricted to caesarean delivery and excluded mothers with depression, providing a clear gap. The hypothesis follows logically from the cited evidence.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The introduction establishes a clear rationale based on prior research, identifies a gap (previous trials excluded depressed mothers), and states a specific hypothesis.

Evidence

“Depression is common among women during the perinatal period, with a reported prevalence of 6-13% in high income countries, 21% in middle income countries, and 26% in low income countries.”

Introduction ¶1Find in source

“However, previous trials were largely restricted to caesarean delivery and excluded mothers with depression and thus at high risk of postpartum depression.”

Introduction ¶4Find in source

“We therefore tested the primary hypothesis that a single low dose of esketamine given shortly after delivery reduces depression over 42 days among mothers with prenatal depression.”

Introduction ¶4Find in source

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise with adequate citation of prior work and a logical rationale linking prenatal depression to postpartum depression risk and the potential of esketamine.

Evidence

“However, previous trials were largely restricted to caesarean delivery and excluded mothers with depression and thus at high risk of postpartum depression.”

Introduction ¶1Find in source

“We therefore tested the primary hypothesis that a single low dose of esketamine given shortly after delivery reduces depression over 42 days among mothers with prenatal depression.”

IntroductionFind in source

“Importantly, our trial extends existing understanding by targeting women with pre-existing prenatal depression, who were therefore at high risk of postnatal depression.”

DiscussionFind in source

Randomization was computer-generated with stratification by site and block size, and allocation was concealed using opaque envelopes. Blinding of participants, healthcare team, and outcome assessors is described. A priori sample size calculation is provided with assumptions. Inclusion/exclusion criteria are clearly defined. The analysis population (ITT and per-protocol) and missing data handling are specified.

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 trial is rigorously designed with adequate randomization, blinding, sample size calculation, and pre-specified inclusion/exclusion criteria.

Evidence

MethodsFind in source

“All participants, healthcare team members, and outcome assessors were therefore fully blinded to treatment.”

MethodsFind in source

“With a two sided significance level set at 0.05 and power at 80%, we determined that 328 participants would be required to detect such a difference.”

Statistical analysisFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous: randomization method, allocation concealment, blinding, sample size calculation, and pre-specified inclusion/exclusion criteria are all adequately reported.

Evidence

“An independent biostatistician generated random treatment assignments in a 1:1 ratio, stratified by trial site, with a block size of four using the PROC PLAN procedure of SAS 9.2 software (SAS Institute, Cary, NC). Allocations were sealed in sequentially numbered opaque envelopes controlled by investigators who were otherwise not involved in data acquisition or the participants’ care.”

MethodsFind in source

“All participants, healthcare team members, and outcome assessors were therefore fully blinded to treatment.”

MethodsFind in source

“With a two sided significance level set at 0.05 and power at 80%, we determined that 328 participants would be required to detect such a difference. We expected a dropout rate of about 10% and thus planned to enrol a total of 364 participants.”

Statistical analysisFind in source

The study reports age, BMI, education, employment, income, and baseline EPDS scores in Table 1. Sex is inherently female (pregnant mothers), and both sexes are not applicable. Age and health status are reported. Demographics are comprehensive.

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· 90% conf

Demographic and clinical characteristics of participants are well reported, including age, BMI, education, and baseline depression scores.

Evidence

“Mean (SD) age (years) | 31.8 (4.0) | 31.7 (4.1)”

Table 1Find in source

“Median (IQR) Edinburgh postnatal depression scale‡‡ | 10 (10 to 12) | 10 (10 to 12)”

Table 1Find in source

PASSReviewer 2· 90% conf

Relevant biological variables for a human trial are reported: sex (all female), age, BMI, and detailed demographics are provided.

Evidence

“The mean age of enrolled participants was 31.8 (SD 4.1) years.”

Table 1Find in source

paraphrase[Table 1]

“Duration of education (years): <9 8 (4.4) 4 (2.2); 9-12 19 (10.4) 9 (4.9); >12 155 (85.2) 169 (92.9)”

“We enrolled pregnant individuals aged 18 years or older with an Edinburgh postnatal depression scale score of ≥10 who were close to childbirth.”

MethodsFind in source

The protocol was approved by the Biomedical Research Ethics Committee of Peking University First Hospital (2019-336) and other centres. Written informed consent was obtained from each participant. The trial was registered at ClinicalTrials.gov.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approval from a named committee and written informed consent are documented.

Evidence

“The Biomedical Research Ethics Committee of Peking University First Hospital (2019-336) and other participating centres approved the study protocol (see supplement 1).”

MethodsFind in source

“Written informed consent was obtained from each participant.”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethical approval from a named committee and informed consent are reported, along with regulatory compliance.

Evidence

“The Biomedical Research Ethics Committee of Peking University First Hospital (2019-336) and other participating centres approved the study protocol (see supplement 1).”

MethodsFind in source

“Written informed consent was obtained from each participant.”

MethodsFind in source

“The trial is reported according to the Consolidated Standards of Reporting Trials guidelines.”

MethodsFind in source

Esketamine is identified as the drug, with dose (0.2 mg/kg) and route (IV infusion over 40 minutes). The placebo is normal saline. Statistical software (SPSS 25.0, SAS 9.2) is identified. No antibodies, cell lines, or other bench reagents are used, so those criteria are not applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

The investigational drug (esketamine) is identified with dose and route, and statistical software is named.

Evidence

“Participants were randomly assigned 1:1 to receive either 0.2 mg/kg esketamine or placebo infused intravenously over 40 minutes after childbirth once the umbilical cord had been clamped.”

AbstractFind in source

“Statistical analyses were performed with the SPSS 25.0 software (IBM SPSS, Chicago, IL).”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The investigational product (esketamine) is adequately identified with dose and regimen; statistical software is identified.

Evidence

“Participants were randomly assigned 1:1 to receive either 0.2 mg/kg esketamine or placebo infused intravenously over 40 minutes after childbirth once the umbilical cord had been clamped.”

AbstractFind in source

“Statistical analyses were performed with the SPSS 25.0 software (IBM SPSS, Chicago, IL).”

Statistical analysisFind in source

The primary endpoint was compared using chi-square test with relative risk and 95% CI. Secondary continuous variables used t-test or Mann-Whitney with median differences and Hodges-Lehmann CIs. Exact p-values are reported (e.g., P<0.001). Software is identified. Data presentation includes per-group n and CIs. Mathematical plausibility checks are not applicable for large-N continuous outcomes.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical tests are named, effect sizes with confidence intervals are reported, and the analysis is appropriate for the trial design.

Evidence

“The prevalence of a major depressive episode at 42 days post partum, our primary endpoint, was compared with a χ 2 test, with differences between groups expressed as relative risk and 95% confidence interval (CI).”

Statistical analysisFind in source

“relative risk 0.26, 95% CI 0.14 to 0.48; P<0.001”

ResultsFind in source

PASSReviewer 2· 90% conf

Statistical tests are named, effect sizes with confidence intervals are reported, and data presentation is adequate for a clinical trial.

Evidence

Statistical analysisFind in source

“relative risk 0.26, 95% CI 0.14 to 0.48; P<0.001”

ResultsFind in source

“Edinburgh postnatal depression scale scores were lower in the esketamine group at seven days (median difference −3, 95% CI −4 to −2; P<0.001)”

ResultsFind in source

The statement says anonymised individual patient data can be made available to researchers who provide a sound proposal, but does not specify a platform, committee, or conditions. This is reported_but_inadequate. No code is shared, but no bespoke code is mentioned.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

A data availability statement exists but is vague, lacking a concrete access mechanism or timeframe.

Evidence

“Anonymised individual patient data can be made available to researchers who provide a sound proposal and”

Data availabilityFind in source

WARNReviewer 2· 80% conf

A data availability statement is present but vague, lacking a concrete access mechanism or timeframe.

Evidence

“Anonymised individual patient data can be made available to researchers who provide a sound proposal and”

Data availabilityFind in source

Trial registration number is provided (NCT04414943). CONSORT guidelines are mentioned. All pre-specified outcomes are reported in tables. Limitations are explicitly discussed. Funding sources 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· 95% conf

The trial is registered, reported per CONSORT, all outcomes are reported, limitations are discussed, and funding/COI are declared.

Evidence

“Trial registration ClinicalTrials.gov NCT04414943 .”

AbstractFind in source

“The trial is reported according to the Consolidated Standards of Reporting Trials guidelines.”

MethodsFind in source

“An important limitation is that we excluded mothers with prepregnancy mood disorders (three mothers were excluded for depression or anxiety), and thus failed to include participants in greatest need of intervention.”

LimitationsFind in source

PASSReviewer 2· 95% conf

The trial is registered, reported per CONSORT, all outcomes are reported, limitations are discussed, and funding/COI are disclosed.

Evidence

“Trial registration ClinicalTrials.gov NCT04414943 .”

AbstractFind in source

“The trial is reported according to the Consolidated Standards of Reporting Trials guidelines.”

MethodsFind in source

LimitationsFind in source

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

Broken references and links

2 findings · worst high

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.

Cites retracted workRecomputed
References not resolvable to a published paperRecomputed

Checked 62 references by DOI: 54 verified — 2 retracted, 3 DOI unresolved, 3 no DOI (shown, not verified).

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 clarity, consistency, other.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is methodologically robust and generally well-reported, but an informed reader should weigh the incomplete data availability statement, the presence of retracted citations, and one overstated claim in the discussion. These issues do not invalidate the core findings but warrant attention; a correction or clarification from the authors would strengthen the record.

1.
HIGHdata code
Complete the data availability statement in the 'Data availability statement' section by specifying a concrete access mechanism (e.g., a data access committee, a repository like Vivli or YODA, or a contact with conditions and timeframe).
The current statement is cut off and vague, failing to meet reproducibility standards for a data-driven clinical trial.
2.
HIGHreporting
Remove or replace the two retracted citations: 'A Study on the Preventive Effect of Esketamine on Postpartum Depression (PPD) after Cesarean Section' (doi:10.1155/2022/1524198) and 'Efficacy and Safety of Esketamine for Supplemental Analgesia During Elective Cesarean Delivery' (doi:10.1001/jamanetworkopen.2023.9321).
Citing retracted works undermines the integrity of the reference list and could mislead readers.
3.
HIGHreporting
Verify or correct the three references not found in any registry: 'Differential validity of SAS and SDS among psychiatric non-psychotic outpatients and their partners' (doi:10.3969/j.issn.1000-6729.2012.09.007), 'Investigation of reliability and validity of the social support scale' (doi:10.3969/j.issn.1009-5551.2008.01.001), and 'The Chinese Marital Quality Inventory: Development, Reliability and Validity' (doi:10.3969/j.issn.1005-3611.2004.03.002).
References that cannot be located in any registry may be fabricated or contain incorrect DOIs, which is a serious integrity concern.
4.
HIGHrigor
Temper the claim in the Discussion that 'the antidepressant effect of low dose esketamine lasts longer in mothers with prenatal depression than in the general population with depression' to reflect that the study only followed up to 42 days and did not directly compare with a general depression population.
The claim is overstated and not directly supported by the data, which is a common reviewer objection.
5.
MEDIUMreporting
Clarify the discrepancy between the abstract's overall neuropsychiatric adverse events (45.1% vs 22.0%) and the safety outcomes section's 'neuropsychiatric symptoms' (33.5% vs 11.0%) by explaining the different definitions or time windows.
The internal contradiction may confuse readers and could be flagged as an inconsistency.
6.
MEDIUMcopyedit
Change 'v' to 'vs' in the Abstract Results section for consistency with the rest of the text.
Inconsistent abbreviation usage is a minor copyedit issue that should be fixed for professionalism.
7.
MEDIUMcopyedit
Clarify the sensitivity analysis in Methods, Statistical analysis by specifying that it is a post hoc analysis and explicitly stating the direction of imputation for each group.
The current description is clear but could be more explicit to avoid misinterpretation.
8.
MEDIUMcopyedit
Clarify the Table 2 footnote 'Merged to avoid identifiability' by specifying which categories were merged and why.
The vague footnote reduces transparency about data handling.
9.
LOWdata code
Consider depositing de-identified aggregate data or statistical analysis code in a public repository (e.g., Zenodo) with a DOI to enhance reproducibility.
While not mandatory, sharing code and aggregate data would strengthen the reproducibility of the trial.

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Efficacy of a single low dose of esketamine after childbirth for mothers with symptoms of prenatal depression: randomised clinical trial.

Wang S, Deng CM, Zeng Y, Chen XZ, Li AY, Feng SW, Xu LL, Chen L, Yuan HM, Hu H, Yang T, Han T, Zhang HY, Jiang M, Sun XY, Guo HN, Sessler DI, Wang DX

Read full text (PMC)

DOI

10.1136/bmj-2023-078218

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Record fingerprint

a65433e207b73716fc9c6e940d4b2d7ac8b01b7186839888bffe81cb563abdd8

Verify via API

Issued Aug 16, 2026Engine 7.39.0

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

Kaimen Rigor review

Kaimen Rigor reviewed

2.75 / 5

Weak — serious problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

CitationsCitations & links (capped) ×5−1★
IntegrityIntegrity concern−0.5★
ClaimsOverstated claim−0.5★
ReportingData & code availability partially met−0.25★

Citations & links are capped at −1★ combined, however many are flagged.

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 8 reported means were read, and their group size is not stated where the values are printed (this source has no machine-readable table structure). These checks need the count the mean was averaged over, so none was performed.
No data or code availability links were detected to verify.

Biggest issues

01Cites retracted work
highAvailabilityrecomputedFull detail
Retraction
“A Study on the Preventive Effect of Esketamine on Postpartum Depression (PPD) after Cesarean Section”
Reference 23Find in source
02Cites retracted work
highAvailabilityrecomputedFull detail
Marked retracted/withdrawn in the Crossref title.
“Efficacy and Safety of Esketamine for Supplemental Analgesia During Elective Cesarean Delivery: A Randomized Clinical Trial”
Reference 52Find in source
03Conclusion reaches beyond the evidence
mediumOverreachreviewer-assessedFull detail
The antidepressant effect of low dose esketamine lasts longer in mothers with prenatal depression than in the general population with depression.
“The antidepressant effect of low dose esketamine thus seems to last longer in mothers with prenatal depression than in the general population with depression.”
Discussion ¶1Find in source

Findings by category

Numerical inconsistencies

1 finding · worst low

Internal contradictions in the reported numbersAssessed

Recomputed 6 tests: 6 consistent, 0 inconsistent; 3 recomputed directly from the reported test statistics, 3 via agent-written checks.

Overstated conclusions

1 finding · worst medium

Conclusions overstated beyond the evidenceAssessed

6 major claims checked against the paper's own evidence: 1 not fully backed by the presented evidence (unsupported or overstated).

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

Data authenticity concerns

None found

Checked — nothing surfaced.

Reporting gaps

1 finding · worst medium

Data/code availability incompleteAssessed

Eight Dimensions7 pass · 1 warn

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The introduction establishes a clear rationale based on prior research, identifies a gap (previous trials excluded depressed mothers), and states a specific hypothesis.

Evidence

“Depression is common among women during the perinatal period, with a reported prevalence of 6-13% in high income countries, 21% in middle income countries, and 26% in low income countries.”

Introduction ¶1Find in source

“However, previous trials were largely restricted to caesarean delivery and excluded mothers with depression and thus at high risk of postpartum depression.”

Introduction ¶4Find in source

“We therefore tested the primary hypothesis that a single low dose of esketamine given shortly after delivery reduces depression over 42 days among mothers with prenatal depression.”

Introduction ¶4Find in source

PASSReviewer 2· 90% conf

Evidence

“However, previous trials were largely restricted to caesarean delivery and excluded mothers with depression and thus at high risk of postpartum depression.”

Introduction ¶1Find in source

“We therefore tested the primary hypothesis that a single low dose of esketamine given shortly after delivery reduces depression over 42 days among mothers with prenatal depression.”

IntroductionFind in source

“Importantly, our trial extends existing understanding by targeting women with pre-existing prenatal depression, who were therefore at high risk of postnatal depression.”

DiscussionFind 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

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

Evidence

MethodsFind in source

“All participants, healthcare team members, and outcome assessors were therefore fully blinded to treatment.”

MethodsFind in source

“With a two sided significance level set at 0.05 and power at 80%, we determined that 328 participants would be required to detect such a difference.”

Statistical analysisFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous: randomization method, allocation concealment, blinding, sample size calculation, and pre-specified inclusion/exclusion criteria are all adequately reported.

Evidence

MethodsFind in source

“All participants, healthcare team members, and outcome assessors were therefore fully blinded to treatment.”

MethodsFind in source

Statistical analysisFind 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· 90% conf

Demographic and clinical characteristics of participants are well reported, including age, BMI, education, and baseline depression scores.

Evidence

“Mean (SD) age (years) | 31.8 (4.0) | 31.7 (4.1)”

Table 1Find in source

“Median (IQR) Edinburgh postnatal depression scale‡‡ | 10 (10 to 12) | 10 (10 to 12)”

Table 1Find in source

PASSReviewer 2· 90% conf

Relevant biological variables for a human trial are reported: sex (all female), age, BMI, and detailed demographics are provided.

Evidence

“The mean age of enrolled participants was 31.8 (SD 4.1) years.”

Table 1Find in source

paraphrase[Table 1]

“Duration of education (years): <9 8 (4.4) 4 (2.2); 9-12 19 (10.4) 9 (4.9); >12 155 (85.2) 169 (92.9)”

“We enrolled pregnant individuals aged 18 years or older with an Edinburgh postnatal depression scale score of ≥10 who were close to childbirth.”

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

Ethical approval from a named committee and written informed consent are documented.

Evidence

“The Biomedical Research Ethics Committee of Peking University First Hospital (2019-336) and other participating centres approved the study protocol (see supplement 1).”

MethodsFind in source

“Written informed consent was obtained from each participant.”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethical approval from a named committee and informed consent are reported, along with regulatory compliance.

Evidence

“The Biomedical Research Ethics Committee of Peking University First Hospital (2019-336) and other participating centres approved the study protocol (see supplement 1).”

MethodsFind in source

“Written informed consent was obtained from each participant.”

MethodsFind in source

“The trial is reported according to the Consolidated Standards of Reporting Trials guidelines.”

MethodsFind in source

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

The investigational drug (esketamine) is identified with dose and route, and statistical software is named.

Evidence

“Participants were randomly assigned 1:1 to receive either 0.2 mg/kg esketamine or placebo infused intravenously over 40 minutes after childbirth once the umbilical cord had been clamped.”

AbstractFind in source

“Statistical analyses were performed with the SPSS 25.0 software (IBM SPSS, Chicago, IL).”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The investigational product (esketamine) is adequately identified with dose and regimen; statistical software is identified.

Evidence

“Participants were randomly assigned 1:1 to receive either 0.2 mg/kg esketamine or placebo infused intravenously over 40 minutes after childbirth once the umbilical cord had been clamped.”

AbstractFind in source

“Statistical analyses were performed with the SPSS 25.0 software (IBM SPSS, Chicago, IL).”

Statistical analysisFind in source

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical tests are named, effect sizes with confidence intervals are reported, and the analysis is appropriate for the trial design.

Evidence

Statistical analysisFind in source

“relative risk 0.26, 95% CI 0.14 to 0.48; P<0.001”

ResultsFind in source

PASSReviewer 2· 90% conf

Statistical tests are named, effect sizes with confidence intervals are reported, and data presentation is adequate for a clinical trial.

Evidence

Statistical analysisFind in source

“relative risk 0.26, 95% CI 0.14 to 0.48; P<0.001”

ResultsFind in source

“Edinburgh postnatal depression scale scores were lower in the esketamine group at seven days (median difference −3, 95% CI −4 to −2; P<0.001)”

ResultsFind in source

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

A data availability statement exists but is vague, lacking a concrete access mechanism or timeframe.

Evidence

“Anonymised individual patient data can be made available to researchers who provide a sound proposal and”

Data availabilityFind in source

WARNReviewer 2· 80% conf

A data availability statement is present but vague, lacking a concrete access mechanism or timeframe.

Evidence

“Anonymised individual patient data can be made available to researchers who provide a sound proposal and”

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· 95% conf

The trial is registered, reported per CONSORT, all outcomes are reported, limitations are discussed, and funding/COI are declared.

Evidence

“Trial registration ClinicalTrials.gov NCT04414943 .”

AbstractFind in source

“The trial is reported according to the Consolidated Standards of Reporting Trials guidelines.”

MethodsFind in source

LimitationsFind in source

PASSReviewer 2· 95% conf

The trial is registered, reported per CONSORT, all outcomes are reported, limitations are discussed, and funding/COI are disclosed.

Evidence

“Trial registration ClinicalTrials.gov NCT04414943 .”

AbstractFind in source

“The trial is reported according to the Consolidated Standards of Reporting Trials guidelines.”

MethodsFind in source

LimitationsFind in source

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

Broken references and links

2 findings · worst high

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.

Cites retracted workRecomputed
References not resolvable to a published paperRecomputed

Checked 62 references by DOI: 54 verified — 2 retracted, 3 DOI unresolved, 3 no DOI (shown, not verified).

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 clarity, consistency, other.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHdata code
Complete the data availability statement in the 'Data availability statement' section by specifying a concrete access mechanism (e.g., a data access committee, a repository like Vivli or YODA, or a contact with conditions and timeframe).
The current statement is cut off and vague, failing to meet reproducibility standards for a data-driven clinical trial.
2.
HIGHreporting
Remove or replace the two retracted citations: 'A Study on the Preventive Effect of Esketamine on Postpartum Depression (PPD) after Cesarean Section' (doi:10.1155/2022/1524198) and 'Efficacy and Safety of Esketamine for Supplemental Analgesia During Elective Cesarean Delivery' (doi:10.1001/jamanetworkopen.2023.9321).
Citing retracted works undermines the integrity of the reference list and could mislead readers.
3.
HIGHreporting
Verify or correct the three references not found in any registry: 'Differential validity of SAS and SDS among psychiatric non-psychotic outpatients and their partners' (doi:10.3969/j.issn.1000-6729.2012.09.007), 'Investigation of reliability and validity of the social support scale' (doi:10.3969/j.issn.1009-5551.2008.01.001), and 'The Chinese Marital Quality Inventory: Development, Reliability and Validity' (doi:10.3969/j.issn.1005-3611.2004.03.002).
References that cannot be located in any registry may be fabricated or contain incorrect DOIs, which is a serious integrity concern.
4.
HIGHrigor
Temper the claim in the Discussion that 'the antidepressant effect of low dose esketamine lasts longer in mothers with prenatal depression than in the general population with depression' to reflect that the study only followed up to 42 days and did not directly compare with a general depression population.
The claim is overstated and not directly supported by the data, which is a common reviewer objection.
5.
MEDIUMreporting
Clarify the discrepancy between the abstract's overall neuropsychiatric adverse events (45.1% vs 22.0%) and the safety outcomes section's 'neuropsychiatric symptoms' (33.5% vs 11.0%) by explaining the different definitions or time windows.
The internal contradiction may confuse readers and could be flagged as an inconsistency.
6.
MEDIUMcopyedit
Change 'v' to 'vs' in the Abstract Results section for consistency with the rest of the text.
Inconsistent abbreviation usage is a minor copyedit issue that should be fixed for professionalism.
7.
MEDIUMcopyedit
Clarify the sensitivity analysis in Methods, Statistical analysis by specifying that it is a post hoc analysis and explicitly stating the direction of imputation for each group.
The current description is clear but could be more explicit to avoid misinterpretation.
8.
MEDIUMcopyedit
Clarify the Table 2 footnote 'Merged to avoid identifiability' by specifying which categories were merged and why.
The vague footnote reduces transparency about data handling.
9.
LOWdata code
Consider depositing de-identified aggregate data or statistical analysis code in a public repository (e.g., Zenodo) with a DOI to enhance reproducibility.
While not mandatory, sharing code and aggregate data would strengthen the reproducibility of the trial.

Full text (54,129 chars)Analyzed: Aug 16, 2026