Dear Dr. Lapat,

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PLOS ONE

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Additional Editor Comments (if provided):

Date: March 21, 2025

Manuscript ID: PONE-D-24-35993 "Obstetric and Newborn Outcomes of Mothers with and without HIV Infection in a General Hospital in Northern Uganda".

General comment:

• The manuscript is with a full grammatical error, awkward sentences, spacing and punctuation. It needs English language editors.

• Issues in the methodology part should addressed.

• Discussion and conclusion of the study along with component the paper should be improved.

• The document should paraphrased.

• Arrange the manuscript based on the journal guideline.

Abstract part

Background: This is a copy and paste of thee introduction part “Women of reproductive age comprise over half of the 39 million people living with HIV worldwide.” Try to paraphrase it.

Method: under this section try to incorporate all methodology component like sample size sampling technique and state the design (method) you applied.

Result section: try to mention only the main outcome of the study only. No need of considering such information “he overall mean age was 22.239 years.” Since, it is not the primary objective of the study.

Conclusion: make the recommendation in line with the finding. You state the general recommendation.

Sampling strategy

Try to omit unnecessary punctuation and clearly state which types of random sampling technique you applied to the first sample specifically.

Sample calculation: please state how to allocate sample for two groups.

Data collection

It expected from to state clearly from where data extraction checklist developed or (adapted), its contents and data quality control method considered in addition to providing training for the data collectors.

Discussion

It is a full spelling and punctuation error and grammatical error. For example line “225”. Apart from congenital anomalies, our found nebron outcome, “Instead of stating such information “CD4+ and viral load information were not obtained. Additionally, reliance on medical records introduces a risk of incomplete or inaccurate reporting.” Clearly state the limitation of the study.

Implications of the study finding

Try to make in line with the finding of the study Based on your finding instead on stating general recommendation such as “routine screening for opportunistic infections such as CMV, toxoplasmosis and syphilis, and provide comprehensive counseling on ART risks and benefits during pregnancy”

Finally, reported the manuscript using strobe reporting checklist for observation studies.

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

Reviewer #1: Yes

Reviewer #2: Yes

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2. Has the statistical analysis been performed appropriately and rigorously? -->?>

Reviewer #1: Yes

Reviewer #2: Yes

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3. Have the authors made all data underlying the findings in their manuscript fully available??>

The PLOS Data policy

Reviewer #1: Yes

Reviewer #2: Yes

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4. Is the manuscript presented in an intelligible fashion and written in standard English??>

Reviewer #1: Yes

Reviewer #2: Yes

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Reviewer #1: The study addresses an important global health issue - the impact of HIV and ART on pregnancy and neonatal outcomes. These days when dolutegravir-based regimens are widespread, the issue of its potential link to congenital anomalies is concerning. The study's retrospective design and substantial sample size are the study's strengths.

However, several aspects of the manuscript could be improved in terms of clarity, methodology, analysis and discussion.

The major concerns are:

1. Study design and sampling. While systematic sampling technique is the strength, its not clear whether all medical charts included were complete and whether those mothers who received care at multiple facilities were included.

2. Confounding variables. Although mentioned in limitation section, such important confounding variables, i.e., opportunistic infections, socioeconomic factors, and CD4 and viral load data that were not collected require stronger discussion of their potential role in the risk of birth defects.

3. Statistical analysis. Sample size of 2 for congenital anomalies is important but very small for this outcome. the use of an adjusted odds ratio (aOR) with such few cases may not be statistically robust. Consider using alternative statistical approaches like exact logistic regression.

Also, confidence intervals (i.e., aOR for congenital anomalies: 1.72-55.48) speaks for considerable uncertainty in the risk estimates. Discussion should be provided as it affects generalizability and reliability of the findings.

4. Discussion. The authors should be careful in the discussion section not to imply causality which may not be a valid conclusion given the small number of anomalies observed and the study design. Also, the authors mention the 2018 Tsepamo study in Botswana (N=426) stating that similar to this study, it reported significantly higher risk of congenital anomalies in HIV-positive women on DTG. However, the authors failed to mention the 2019 updated results of Tsepamo study with much larger sample (1683 pregnancies exposed to DTG) which showed an updated and recalculated lower prevalence of 0.3 versus 0.9 in the initial report.

Conclusion: this manuscript presents important findings contributing to the understanding of neonatal and maternal outcomes in HIV-positive women, particularly in relation to risks associated with dolutegravir. However, improvements in methodology, statistical analysis and discussion would strengthen this manuscript.

Reviewer #2: � The paper manuscript is well organized except some errors which I commented on it

� Please add variables which are not included in previous studies like viral load and CD4 count and others.

� Try to show the gaps of previous studies and significance of this study.

� Minor revision is required, the manuscript is well addressed.

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Reviewer #1: No

Reviewer #2: Yes:  Endinew Beka Mehiretie

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Attachments

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Submitted filename: PLOS.docx

Obstetric and Newborn Outcomes of Mothers with and without HIV Infection in Anaka General Hospital in Northern Uganda

PONE-D-24-35993R1

Dear Dr. Lapat,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

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Kind regards,

Keralem Anteneh Bishaw, Msc.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

I appreciate the author’s efforts in addressing the reviewers’ and editors’ concerns thoroughly. While the retrospective nature of the study imposes certain limitations, including the inability to incorporate some key variables, the findings offer valuable insights to the scientific community. The finding of this study highlights the need for further investigation through higher-level studies, such as prospective cohort or experimental designs.

Despite the noted limitations, we believe the manuscript makes a meaningful contribution to the field and recommend its acceptance for publication in its current form.

Reviewers' comments: