PONE-D-24-26866Comparing membrane sweep and cervical massage in preventing the need for formal labour induction in uncomplicated pregnancy at term: Secondary analysis of a randomized controlled trial.PLOS ONE

Dear Dr. Madugalle,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

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We look forward to receiving your revised manuscript.

Kind regards,

Nishel Mohan Shah, PhD

Academic Editor

PLOS ONE

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Additional Editor Comments:

Dear authors,

Thank you for submitting this paper. The reviewers have recommended minor revisions and have outlined a series of comments to improve your work. Please go through these comments and we will be happy to review a revised manuscript.

Yours sincerely,

Nishel

Reviewer 1:

This manuscript reports secondary analysis results of a randomized controlled clinical trial investigating membrane sweep and cervical massage in preventing the need for formal

labour induction in uncomplicated pregnancy at term. My comments are listed in the following.

In the Method section, please provide descriptions of statistical methods used for comparing outcome rates between groups.

Please correct “long-Rank mantel-Cox test” as “log-rank test”. Please note that it’s log-rank instead of long-rank. Since “log-rank test” is sometimes called “Mantel-Cox test”, you don’t have to put both names together.

Line 220-221, What’ RR and OR? How were they calculated? Please define acronyms the first time they appear in the text.

In the results, it is better to use “RR=” and “95% CI=” rather than “RR-” or “95% CI-”.

Line 255, “due to small subgroup size” is not the reason for insignificant difference since multiparous group has even smaller size but with significant difference.

In table 10, please add p values for each outcome. Those “0” p-values for comparing 0% vs. 0% are not correct. They should be close to 1. It’s better to ask a biostatistician to guide and help with the data analysis.

Reviewer 2:

Abstract is longer than recommended 300 words and would benefit from having headings (introduction, methodology, results, conclusion).

Some grammar amendments to improve readability such as:

105- '...a far larger area of chorio-amnion off the decidua...'. The word 'off' should be replaced by 'of'. This is a recurrent theme throughout the manuscript.

135- After first coma should be 'and' or if coma is kept 'they'.

[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?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Partly

Reviewer #2: Yes

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

Reviewer #1: N/A

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 requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: No

Reviewer #2: Yes

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

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: No

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5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: This manuscript reports secondary analysis results of a randomized controlled clinical trial investigating membrane sweep and cervical massage in preventing the need for formal

labour induction in uncomplicated pregnancy at term. My comments are listed in the following.

In the Method section, please provide descriptions of statistical methods used for comparing outcome rates between groups.

Please correct “long-Rank mantel-Cox test” as “log-rank test”. Please note that it’s log-rank instead of long-rank. Since “log-rank test” is sometimes called “Mantel-Cox test”, you don’t have to put both names together.

Line 220-221, What’ RR and OR? How were they calculated? Please define acronyms the first time they appear in the text.

In the results, it is better to use “RR=” and “95% CI=” rather than “RR-” or “95% CI-”.

Line 255, “due to small subgroup size” is not the reason for insignificant difference since multiparous group has even smaller size but with significant difference.

In table 10, please add p values for each outcome. Those “0” p-values for comparing 0% vs. 0% are not correct. They should be close to 1. It’s better to ask a biostatistician to guide and help with the data analysis.

Reviewer #2: Abstract is longer than recommended 300 words and would benefit from having headings (introduction, methodology, results, conclusion).

Some grammar amendments to improve readability such as:

105- '...a far larger area of chorio-amnion off the decidua...'. The word 'off' should be replaced by 'of'. This is a recurrent theme throughout the manuscript.

135- After first coma should be 'and' or if coma is kept 'they'.

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6. PLOS authors have the option to publish the peer review history of their article (what does this mean? ). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy .

Reviewer #1: No

Reviewer #2: Yes:  Maria Amparo Buaki-Sogo

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PONE-D-24-26866R1Comparing membrane sweep and cervical massage in preventing the need for formal labour induction in uncomplicated pregnancy at term: secondary analysis of a randomized controlled trialPLOS ONE

Dear Dr. Madugalle,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

Please submit your revised manuscript by Apr 16 2025 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org . When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

• A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
• A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
• An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols . Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols .

We look forward to receiving your revised manuscript.

Kind regards,

Nishel Mohan Shah, PhD

Academic Editor

PLOS ONE

Journal Requirements:

Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

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

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: (No Response)

Reviewer #2: All comments have been addressed

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

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: (No Response)

Reviewer #2: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: (No Response)

Reviewer #2: Yes

**********

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

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: (No Response)

Reviewer #2: Yes

**********

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

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: (No Response)

Reviewer #2: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: “probability values” doesn’t mean “P-values” from a statistical test. You should not say “P value at 95% CI” since the P value is not obtained at 95% CI.

Please ask a biostatistician to help with professional writeup/edits in statistics methods and analysis results. The following are some examples for revisions/corrections.

Lines 180-181, the sentence “…groups were compared using standard deviation, standard error of the mean, and t-tests to calculate probability (p) values at 95% confidence intervals.” Doesn’t described in a professional way. It may be revised as “…groups were compared using t-tests and P-values with 95% confidence intervals are reported.”

The title of Table 7 should be revised as “P-values from Log rank tests for comparisons of “survival” curves after Membrane sweep (MS) versus Cervical massage.” Through the text, since the studied end point is time to spontaneous labor rather than survival, to avoid confusion, I would replace the term “survival” without spontaneous labor using “Proportion of subjects without spontaneous labor”.

In Table 8, “P value at 95% CI” should be corrected as “P value”.

Lines 224-225, “Subgroup analysis according to parity did not show any statistically significant difference between any methods due to the small individual sub-group size.” I have mentioned last time, the reason of insignificance might not be due to small sample size. To be informative, please add more contents to Table 6 with the data in subgroups of parity to show if there are any potential differences in outcomes by parity.

Lines 258-260, the conclusion based on overall data may be misleading. To give complete information, please add sentences to state that the shorter period only be significant in multiparous group.

Reviewer #2: (No Response)

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7. PLOS authors have the option to publish the peer review history of their article (what does this mean? ). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy .

Reviewer #1: No

Reviewer #2: No

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[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/ . PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org . Please note that Supporting Information files do not need this step.

Comparing membrane sweep and cervical massage in preventing the need for formal labour induction in uncomplicated pregnancy at term: secondary analysis of a randomized controlled trial

PONE-D-24-26866R2

Dear Dr. Madugalle,

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.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

An invoice will be generated when your article is formally accepted. Please note, if your institution has a publishing partnership with PLOS and your article meets the relevant criteria, all or part of your publication costs will be covered. Please make sure your user information is up-to-date by logging into Editorial Manager at Editorial Manager®  and clicking the ‘Update My Information' link at the top of the page. If you have any questions relating to publication charges, please contact our Author Billing department directly at authorbilling@plos.org.

If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org.

Kind regards,

Nishel Mohan Shah, PhD

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

**********

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

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: (No Response)

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: (No Response)

**********

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

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: (No Response)

**********

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

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: (No Response)

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: (No Response)

**********

7. PLOS authors have the option to publish the peer review history of their article (what does this mean? ). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy .

Reviewer #1: No

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