Glycemic control and fetal growth of women with diabetes mellitus and subsequent hypertensive disorders of pregnancy

Mamoru Morikawa; Emi Kato-Hirayama; Michinori Mayama; Yoshihiro Saito; Kinuko Nakagawa; Takeshi Umazume; Kentaro Chiba; Satoshi Kawaguchi; Kazuhiko Okuyama; Hidemichi Watari

doi:10.1371/journal.pone.0230488

Peer Review History

Original SubmissionDecember 15, 2019
21 Jan 2020 Decision Letter - Frank T. Spradley, Editor PONE-D-19-34650 Glycemic control and fetal growth of women with both diabetes mellitus and hypertensive disorders of pregnancy PLOS ONE Dear Dr Morikawa, 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. SPECIFIC ACADEMIC EDITOR COMMENTS. There were several major concerns raised by the reviewer that must be addressed. These relate to the need for extensive editing of English grammar and syntax; the abstract and introduction need to be significantly revised to provide more appropriate rationale/background information; the methods need to be strengthened; and the discussion needs to better present the current findings in relationship to more discussion of the published literature. We would appreciate receiving your revised manuscript by Mar 06 2020 11:59PM. When you are 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. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. To enhance the reproducibility of your results, we recommend that if applicable you deposit your laboratory protocols in protocols.io, where a protocol can be assigned its own identifier (DOI) such that it can be cited independently in the future. 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We look forward to receiving your revised manuscript. Kind regards, Frank T. Spradley Academic Editor PLOS ONE Journal requirements: When submitting your revision, we need you to address these additional requirements: 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at http://www.plosone.org/attachments/PLOSOne_formatting_sample_main_body.pdf and http://www.plosone.org/attachments/PLOSOne_formatting_sample_title_authors_affiliations.pdf 2. Please provide additional details regarding participant consent. In the ethics statement in the Methods and online submission information, please ensure that you have specified what type of consent you obtained (for instance, written or verbal). If your study included minors under age 18, state whether you obtained consent from parents or guardians. If the need for consent was waived by the ethics committee, please include this information. 3. Thank you for stating the following in the Acknowledgments Section of your manuscript: "First authors received funding from Suzuki Diabetes Foundation (Tokyo, Japan) to publish this article (for the English language reviewing charge and article processing charge)." We note that you have provided funding information that is not currently declared in your Funding Statement. However, funding information should not appear in the Acknowledgments section or other areas of your manuscript. We will only publish funding information present in the Funding Statement section of the online submission form. Please remove any funding-related text from the manuscript and let us know how you would like to update your Funding Statement. Currently, your Funding Statement reads as follows: "No" 4. Thank you for stating the following in your Competing Interests section: "No" Please complete your Competing Interests on the online submission form to state any Competing Interests. If you have no competing interests, please state "The authors have declared that no competing interests exist.", as detailed online in our guide for authors at http://journals.plos.org/plosone/s/submit-now This information should be included in your cover letter; we will change the online submission form on your behalf. 5. In your Data Availability statement, you have not specified where the minimal data set underlying the results described in your manuscript can be found. PLOS defines a study's minimal data set as the underlying data used to reach the conclusions drawn in the manuscript and any additional data required to replicate the reported study findings in their entirety. All PLOS journals require that the minimal data set be made fully available. For more information about our data policy, please see http://journals.plos.org/plosone/s/data-availability. Upon re-submitting your revised manuscript, please upload your study’s minimal underlying data set as either Supporting Information files or to a stable, public repository and include the relevant URLs, DOIs, or accession numbers within your revised cover letter. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. Any potentially identifying patient information must be fully anonymized. Important: If there are ethical or legal restrictions to sharing your data publicly, please explain these restrictions in detail. Please see our guidelines for more information on what we consider unacceptable restrictions to publicly sharing data: http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. Note that it is not acceptable for the authors to be the sole named individuals responsible for ensuring data access. We will update your Data Availability statement to reflect the information you provide in your cover letter. (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: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes ****** 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: Yes ****** 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: No ****** 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: Mamoru Morikawa et al tried to clarify the To clarify the relationship between glycemic control and fetal growth restriction (FGR) in women with diabetes mellitus (DM) and/or hypertensive disorder of pregnancy in this study. The following changes shall be made for further clarity. 1. Mandatory -Extensive English language edition is must and the paper should be prepared as per the journal instruction. 2. The title of the manuscript should be amended. What is the meaning of "both diabetes mellitus" and it is not a scientific word. 3. Abstract -Background of the study should be included and Methods section should be improved. 4. Introduction -This section is poorly presented. 5. Materials and Methods: Study design and inclusion and exclusion criteria of the study should be included (In a separate section 6. Discussion: More scientific evidences should be included 6. Conclusions should be rephrased. ****** 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 [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 to be viewed.] 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 us at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0230488.r001
Revision 1
10 Feb 2020 Author Response We thank you for your constructive suggestions, which have helped us to improve our manuscript. We have revised the text accordingly and the modifications are indicated in blue. Our point-by-point responses to the reviewer comments have been provided. PONE-D-19-34650 Glycemic control and fetal growth of women with both diabetes mellitus and hypertensive disorders of pregnancy PLOS ONE Dear Dr Morikawa, 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. Response: Thank you for your consideration. SPECIFIC ACADEMIC EDITOR COMMENTS. There were several major concerns raised by the reviewer that must be addressed. These relate to the need for extensive editing of English grammar and syntax; the abstract and introduction need to be significantly revised to provide more appropriate rationale/background information; the methods need to be strengthened; and the discussion needs to better present the current findings in relationship to more discussion of the published literature. Response: We have revised the text per your remarks and modifications are indicated in blue. Our point-by-point responses to the reviewer comments have been provided. We would appreciate receiving your revised manuscript by Mar 06 2020 11:59PM. When you are 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. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. To enhance the reproducibility of your results, we recommend that if applicable you deposit your laboratory protocols in protocols.io, where a protocol can be assigned its own identifier (DOI) such that it can be cited independently in the future. For instructions see: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols 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). This letter should be uploaded as separate file and labeled 'Response to Reviewers'. • A marked-up copy of your manuscript that highlights changes made to the original version. This file should be uploaded as separate file and labeled 'Revised Manuscript with Track Changes'. • An unmarked version of your revised paper without tracked changes. This file should be uploaded as separate file and labeled 'Manuscript'. Response: We have submitted the “Response to Reviewers,” “Revised Manuscript with Track Changes,” and “Manuscript” files according to your comment. Please note while forming your response, if your article is accepted, you may have the opportunity to make the peer review history publicly available. The record will include editor decision letters (with reviews) and your responses to reviewer comments. If eligible, we will contact you to opt in or out. Response: Tthank you for the comments. We look forward to receiving your revised manuscript. Response: We appreciate your comments. Kind regards, Frank T. Spradley Academic Editor PLOS ONE Journal requirements: When submitting your revision, we need you to address these additional requirements: 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at http://www.plosone.org/attachments/PLOSOne_formatting_sample_main_body.pdf and http://www.plosone.org/attachments/PLOSOne_formatting_sample_title_authors_affiliations.pdf Response: Accordingly, we have edited it according to the PLOS ONE style templates. 2. Please provide additional details regarding participant consent. In the ethics statement in the Methods and online submission information, please ensure that you have specified what type of consent you obtained (for instance, written or verbal). If your study included minors under age 18, state whether you obtained consent from parents or guardians. If the need for consent was waived by the ethics committee, please include this information. Response: We have added ethical approval information in the Materials and methods as follows: All women provided verbal informed consent to participate in the study. The information of this clinical study is released to the public via the website of Hokkaido University Hospital according to the recommendations of the Ministry of Health, Labor, and Welfare (Japan). Fortunately, all 154 women were at least 20 years old at the time of delivery. 3. Thank you for stating the following in the Acknowledgments Section of your manuscript: "First authors received funding from Suzuki Diabetes Foundation (Tokyo, Japan) to publish this article (for the English language reviewing charge and article processing charge)." We note that you have provided funding information that is not currently declared in your Funding Statement. However, funding information should not appear in the Acknowledgments section or other areas of your manuscript. We will only publish funding information present in the Funding Statement section of the online submission form. Please remove any funding-related text from the manuscript and let us know how you would like to update your Funding Statement. Currently, your Funding Statement reads as follows: "No" Response: We apologize for our error. We have edited the text according to your suggestion. We have removed our “Funding Statement” from the Acknowledgments section and uploaded it to the online submission form. 4. Thank you for stating the following in your Competing Interests section: "No" Please complete your Competing Interests on the online submission form to state any Competing Interests. If you have no competing interests, please state "The authors have declared that no competing interests exist.", as detailed online in our guide for authors at http://journals.plos.org/plosone/s/submit-now This information should be included in your cover letter; we will change the online submission form on your behalf. Response: We have added the following statement in our revised cover letter: “The authors have declared that no competing interests exist.” In addition, we have updated the online submission form accordingly. 5. In your Data Availability statement, you have not specified where the minimal data set underlying the results described in your manuscript can be found. PLOS defines a study's minimal data set as the underlying data used to reach the conclusions drawn in the manuscript and any additional data required to replicate the reported study findings in their entirety. All PLOS journals require that the minimal data set be made fully available. For more information about our data policy, please see http://journals.plos.org/plosone/s/data-availability. Upon re-submitting your revised manuscript, please upload your study’s minimal underlying data set as either Supporting Information files or to a stable, public repository and include the relevant URLs, DOIs, or accession numbers within your revised cover letter. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. Any potentially identifying patient information must be fully anonymized. Response: We could not obtain DOIs. We have uploaded our data set and also added the data set in the revised cover letter and revised manuscript. Supporting information S1 File. Women with DM data. Data set (XLSX). Important: If there are ethical or legal restrictions to sharing your data publicly, please explain these restrictions in detail. Please see our guidelines for more information on what we consider unacceptable restrictions to publicly sharing data: http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. Note that it is not acceptable for the authors to be the sole named individuals responsible for ensuring data access. We will update your Data Availability statement to reflect the information you provide in your cover letter. Response: We have no ethical or legal restrictions to share our data publicly. We have added our Data Availability statement in the revised cover letter per your suggestion. (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: Yes Response: Thank you for the comments. 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Response: Thank you for the comments. 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: Yes Response: Thank you for the comments. 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: No Response: Our revised manuscript has been submitted for English language review to Enago (www.enago.jp). 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: Mamoru Morikawa et al tried to clarify the To clarify the relationship between glycemic control and fetal growth restriction (FGR) in women with diabetes mellitus (DM) and/or hypertensive disorder of pregnancy in this study. The following changes shall be made for further clarity. Response: Thank you for the comments. We have edited our manuscript according to your comments. 1. Mandatory -Extensive English language edition is must and the paper should be prepared as per the journal instruction. Response: Our revised manuscript has been submitted for English language review to Enago (www.enago.jp). 2. The title of the manuscript should be amended. What is the meaning of "both diabetes mellitus" and it is not a scientific word. Response: We have removed “both” and added “subsequent” to the title of the revised manuscript as follows: “Glycemic control and fetal growth of women with diabetes mellitus and subsequent hypertensive disorders of pregnancy” 3. Abstract -Background of the study should be included and Methods section should be improved. Response: We have edited the abstract to <300 words and added the background of the study before the aim as follows: “We aim to clarify the relationship between glycemic control and fetal growth in women with DM and/or subsequent HDP.” Background of the study: “Pregnant women with diabetes mellitus (DM) are at high risk for hypertensive disorder of pregnancy (HDP). Women with poor control DM sometimes have heavy-for-dates (HFD) infants. However, women with HDP sometimes have light-for-dates infants.” We have edited the methods of the abstract as follows: “Of 7893 women with singleton births at or after 22 GW, we enrolled 154 women with type 1 (T1DM) or type 2 DM (T2DM) whose infants did not have fetal abnormalities. Among women with T1DM or T2DM, the characteristics of the three groups…” 4. Introduction -This section is poorly presented. Response: We have added new details in Introduction section accordingly. 5. Materials and Methods: Study design and inclusion and exclusion criteria of the study should be included (In a separate section) Response: We have included the “Study design” and “Inclusion and exclusion criteria” in the Materials and methods sections as follows: Study design This retrospective cohort study was conducted in the perinatal medical centers of two institutions with maternal–fetal intensive care and neonatal intensive care units. The two institutions (Hokkaido University Hospital and Sapporo City Hospital) are located in Sapporo City with a population of 1.97 million and both institutions have specialists (medical doctors) in perinatal medicine and DM. These physicians worked in the Department of Obstetrics and Gynecology or the Department of Internal Medicine II, Hokkaido University Graduate School of Medicine. Inclusion and exclusion criteria Between January 2011 and December 2018, 7893 women gave birth at or after 22 GW at the two institutions. Of these, 154 women with DM who had singleton births were enrolled. Of these, those with “overt DM during pregnancy” [19-21] were included as having T2DM. Fortunately, all women were at least 20 years old at the time of delivery. Women whose infants had fetal chromosomal abnormality were excluded as well as those who gave birth to twins or triplets. 6. Discussion: More scientific evidences should be included Response: We have provided new information in the Discussion section accordingly. 6. Conclusions should be rephrased. Response: We have edited this section as follows: Conclusions Poor control of DM is linked to HDP and FGR. The insufficient treatment of DM before pregnancy increases the risk of HDP. Mothers of infants with FGR might have a remarkably lighter placenta and require a considerably higher insulin dosage at delivery than expected because of the placental dysfunction caused by HDP. 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 Response: We agree with your response. [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 to be viewed.] Response: Thank you for the comments. We have resubmitted our manuscript according to your comments. 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 us at figures@plos.org. Please note that Supporting Information files do not need this step. Response: We have uploaded our figures to PACE. https://doi.org/10.1371/journal.pone.0230488.r002
3 Mar 2020 Decision Letter - Frank T. Spradley, Editor Glycemic control and fetal growth of women with diabetes mellitus and hypertensive disorders of pregnancy PONE-D-19-34650R1 Dear Dr. Morikawa, We are pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it complies with all outstanding technical requirements. Within one week, you will receive an e-mail containing information on the amendments required prior to publication. When all required modifications have been addressed, you will receive a formal acceptance letter and your manuscript will proceed to our production department and be scheduled for publication. Shortly after the formal acceptance letter is sent, an invoice for payment will follow. To ensure an efficient production and billing process, please log into Editorial Manager at https://www.editorialmanager.com/pone/, click the "Update My Information" link at the top of the page, and update your user information. If you have any billing related questions, 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 enable them to help maximize its impact. If they will be preparing press materials for this manuscript, you must inform our press team as soon as possible and 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. With kind regards, Frank T. Spradley Academic Editor PLOS ONE 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: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: 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: 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: 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: Author tried to address all the comments. There is a need of correcting typographical or grammatical errors. ****** 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 https://doi.org/10.1371/journal.pone.0230488.r003
Formally Accepted
5 Mar 2020 Acceptance Letter - Frank T. Spradley, Editor PONE-D-19-34650R1 Glycemic control and fetal growth of women with diabetes mellitus and hypertensive disorders of pregnancy Dear Dr. Morikawa: I am pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please notify them about your upcoming paper at this point, to enable them to help maximize its impact. If they will be preparing press materials for this manuscript, please inform our press team within the next 48 hours. 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. For any other questions or concerns, please email plosone@plos.org. Thank you for submitting your work to PLOS ONE. With kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Frank T. Spradley Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0230488.r004

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