PONE-D-23-22773Determinants of Stillbirth among Women Who Delivered in Hospitals of North Wollo Zone, Northeast Ethiopia: An Unmatched Case-Control StudyPLOS ONE

Dear Dr. Abriham,

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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PLOS ONE

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https://www.statpearls.com/articlelibrary/viewarticle/23722/?utm_campaign=reviews&utm_content=23722&utm_source=pubmed

https://idswater.com/2020/08/08/what-is-the-chance-of-having-a-stillborn-baby/

https://threadreaderapp.com/hashtag/stillbirth

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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: Partly

Reviewer #3: Yes

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

Reviewer #1: No

Reviewer #2: Yes

Reviewer #3: 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: Yes

Reviewer #2: Yes

Reviewer #3: 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

Reviewer #3: Yes

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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: Thank you for the submission. The article you have presented gives a very good overview of the determinants implicated in stillbirths in the region of North Wollo Zone, Northeast Ethiopia. Overall, the article is publishable with revisions which will contribute to the transparency of the article and clarify some questions about the methodology.

Methods

1. You have mentioned the exclusion of charts with missing/and incomplete information. That is good. But, it is good practice to explicitly state the criteria for which you have excluded specific variables for cases. Perhaps a table or a supplementary file detailing inclusion and exclusion criteria will benefit transparency and reproducibility.

2. Data collection amongst collectors is a point for improvement. How was inter-reliability ensured amongst the data collectors? This could be further elaborated in the methods section

3. Bivariate logistic regression analysis with p < 0.2

o This point is a big point of contention within the statistical community and is not sound practice. The discussion of deciding on factors to be included or excluded based on p value is dubious.

o The point, thereby, is this is not the way to do it – Making multivariate decisions based on univariate analysis.

o I will point you to the following references. Indeed, the authors need to select better methods to produce models.

Huberty, C. J (1989). Problems with stepwise methods: Better alternatives. In B. Thompson (Ed.) Advances in social science methodology (Vol. 1) (pp. 43-70). Greenwich, CT: JAI Press.

Thompson, B. (1995). Stepwise regression and discriminant analysis need not apply here: A guidelines editorial. Educational and Psychological Measurement, 55(4), 525-534.

Discussion

1. There is no discussion of the limitations. What are the limitations of the study? For example, the use of retrospective data, biases in data collection, and study design. Are these not relevant topics to be discussed?

2. There are elements of limited author’s interpretation of the results in the discussion.

a. The authors have done well to convey that the findings are congruent with literature but do not sparsely discuss potential mechanisms for their findings that separate them by area. For instance, “

These results are consistent with existing studies that have also identified preterm and postterm pregnancies as risk factors for stillbirth [21, 31, 37, 38]. The increased risk observed in preterm births may be attributed to respiratory complications caused by the immaturity of the respiratory system [39]. Additionally, premature fetuses may be more vulnerable to ischemia due to incomplete blood-brain barrier development, potentially leading to fetal demise during delivery [40].”

Were the findings greater, less than or have odds ratios compatible with the other articles? Why may that be so? Are the health systems the same? Are the women of the same population. The discussion is very sparse and does not add valuable insight. This is more so a brief explanation of the attributable factors in the results.

3. Future directions.

a. What could the authors do to add on guidance for further studies to enhance/address the limitations within this study so that you offer a more comprehensive understanding to the issue.

4. Could practical implications be discussed within the article? This could greatly improve the discussion given. For example, discussing the results in the scope of literature allows for the credibility of the results. What actions can be taken based on these? Are they also congruent with those in the other studies? Do you suggest anything different based on the given context?

Overall, it is a good start that needs to be further refined before publication. Please do not be discouraged.

Reviewer #2: Background:

"Almost 98% of the stillbirth rate concentrated [Could this be "is/was concentrated"?] among low- and middle-income countries (LMICs).

Even from the LMICs [Could this be "Even among the LMICs"?), about 77% of the burden was in SSA and South East Asian countries [3]"

The 2016 Ethiopian Demographic and Health Survey (EDHS) showed ......, where the study is going to be conducted [4]. [Check the grammar here. Should it be.. "where the study was conducted" instead of going to be conducted?]

However, their grief is often not socially recognized nor fully acknowledged by doctors or society [8-10]. [Should this part refer to healthcare providers in general and not just doctors?]

Stillbirth have financial consequences for parents and long-term economic repercussions for society [11]. [Check grammar]

It will also exacerbate the risk of maternal mortality since stillbirth is associated with short intervals between pregnancies and women still do

not receive appropriate and respectful care when their baby dies during pregnancy or childbirth [12, 13]. [Be consistent in the use of tenses].

Moreover, stillbirths are not specifically targeted in important international initiatives such as the Sustainable Development Goals (SDGs) and the Millennium Development Goals (MDGs). [We are past the MDGs era, so could the grammar be adjusted accordingly? Say something like- stillbirth has neither been specifically targeted in past nor present important int'l initiatives... or something along the lines.

Furthermore, the civil war in northern Ethiopia has had a detrimental impact on maternal health

services, leading to a high incidence of stillbirths. Given these circumstances, it becomes crucial

to gather data on the determinants of stillbirths in order to plan and prioritize maternal and child

healthcare services effectively, aiming to reduce the frequency and consequences of stillbirths.

Unfortunately, there is limited information available on the determinants of stillbirths specific to

the study area. [There has been no prior reference to Ethiopian context in the manuscript before jumping on to this specific sentence about the country. Add some contextual information about the country first].

Therefore, this study aimed to identify the determinant factors that contribute to stillbirths among women who delivered in hospitals within the North Wollo Zone of Northeast Ethiopia. [There is a need for more contextual information on why this area of the country was chosen for this study- is this region more disadvantaged than the rest of the country? Or something else...?]

Methods:

In this unmatched case-control study conducted at a healthcare institution, data were collected over a period of one month, specifically from January 1 to January 30, 2023. [Some tightening in the writing needed here.. Could say something like - "In this...institution, data collection was carried out over a period of one month from January 1-30, 2023...." or something along the lines].

However, charts with missing or incomplete information regarding key variables.. [information 'on/about' key variables?]

Controls: Women who gave live births after 28th weeks of gestations: [28 weeks of gestation?]

Cord accidents: If there was cord prolapse, cord knot, and/or nuchal cord, it was considered that there was a cord accident in this study. [Can "in this study" be removed?]

Data collection for this study was conducted using a structured checklist that was developed in the English language... [in English.]

with three degree holder midwives.. Not clear what this means. Master's degree?

Results:

Regarding the residence, 252 (61.2%) of the study subjects were rural dwellers, with 63 (25.0%) being cases and 189 (75.0%) being controls. [The first 3 words can be removed- the writing in this manuscript needs tightening].

In terms of partograph use, partograph was used in 47 (45.6%) of the case women' labor and 222 (71.8%) of the control women' labor. [Do the writers mean 'women's..."?]

Figure 1: The spelling of "controls" in the index needs to be corrected to "controls"

About 90 (87.4%) of the cases and 288 (93.2%) of the control women had previously been pregnant multiple times. [If saying 90 women specifically, best to avoid the use of "about"]

Table 1- type of pregnancy- spelling of twins needs to be corrected.

Be consistent on how you write p-value and stick to one format.

Table 2: P in Pregnancy does not need capitalisation.

Discussion:

Although further investigation is warranted, one possible explanation is that carrying a female fetus increases the risk of fetal growth restriction... Could this be elaborated a little as this is an unusual finding?

Conclusion:

Importantly, many of these factors are modifiable and amenable to interventions. " Which one of these are modifiable and amenable to interventions and what could be some examples of influencing/modifying these factors? Some contextual elaboration would be helpful"

Therefore, it is crucial for the Ethiopian Ministry of Health and other relevant stakeholders to prioritize strengthening the utilization of partographs and establishing a robust referral system. "Which of the issues identified by the study will be addressed by robust referrals?"

Overall comments:

Background: This section needs more contextual information on Ethiopia and the region where the study has been conducted. Fix grammatical errors.

Methods: Information on whether multicollinearity between variables was assessed has not been provided. Was multicollinearity assessed? Would also be helpful to see in more detail how the variables were chosen for this study.

Reviewer #3: Determinants of Stillbirth among Women Who Delivered in Hospitals of North Wollo Zone, Northeast Ethiopia: An Unmatched Case-Control Study

Title of study:

The title of study seems very big.

Abstract:

Remove this line: “Factors such as premature rupture of membranes, induced onset of labor, labor duration of 24 hours or more, absence of partograph use during labor, preterm birth, postterm birth, and carrying a female fetus were found to be significantly associated with a higher risk of stillbirth.” Because it is already presented in results of abstract section.

Introduction:

You can write no before heartbeat, no pulsation, and no definite movements of voluntary muscles in the following sentence absent breathing, heartbeats, pulsation of the umbilical cord, or definite movements of voluntary muscles.

The background information regarding the still birth is very comprehensive and presented in very clear language. I feel that your background lacks citations, especially the last four paragraphs of your introduction section. Additionally, I would suggest you remove the content related to the psychological well being and financial spending, because I did not find anything in other sections. Moreover, you need to summarize your introduction to maximum 600-700 words.

Methods:

Keep a separate heading for study design. In the first line of your study design heading, you need to show you have retrospectively analysed one year data, of which you classified X as control and Y as cases. Because this is the unmatched case-control study, so you need to define your cases and control.

Write full forms of ANC.

How you selected 3 hospital randomly? I am interested to know further.

How birth were classified as still birth and live birth? You need to present it with proper citations.

Remove operation definition and terms and all the contents. Rather present all the terminologies and definition within the text, where/if needed. For example: You need to present definition of cases and control of your study in the study design section.

Can you please put your checklist in the supplementary file.

In the main analysis of your method section, VIF and multicollinearity is not discussed. However, in the abstract methodology you presented.

Results:

I read your complete results and I found that everywhere, you are writing the percentage of cases and control. For descriptive statistics, you need to present sample characteristics rather than of each subgroup. However, for presenting the difference between sample characteristics you need to show statistically using some inferential statistics. I am requesting you delete all the descriptive, where you are comparing X% control and X% cases. Rather present whole sample characteristics and write specifically for control and cases if statistical difference between two groups exist (highly recommended changes).

Table 1: Write full form of APH, PROM and SVD in the footnote of table 1.

What are the congenital anormalities observed. You need to write % of all congenital anormalities observed.

Discussion:

Very clear and concise. Seek help from the author for writing introduction.

Also write strengths limitation of your study before conclusion.

I am also interested to know about the implications of this study.

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Reviewer #1: No

Reviewer #2: Yes: Rupesh Gautam

Reviewer #3: Yes: Asif Khaliq

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PONE-D-23-22773R1Determinants of Stillbirth among Women Who Delivered in Hospitals of North Wollo Zone, Northeast Ethiopia: A Case-Control Study.PLOS ONE

Dear Dr. Bizuneh,

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 Mar 14 2024 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,

Abera Mersha, MSc.

Academic Editor

PLOS ONE

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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.

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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

Reviewer #2: 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

Reviewer #2: Yes

**********

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

Reviewer #1: Yes

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: Yes

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: Yes

Reviewer #2: No

**********

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 further comments. The work is rigorous enough for publication.

Reviewer #2: Thank you for the opportunity to have a look at the manuscript once again. The authors have made most changes pointed out in the first round.

The findings also provide strength to the argument that if the identified (and amendable) interventions are implemented by the local health authorities, it might help bring down the total number of preventable stillbirths. So, the study does have merits in the local context (as well as comparable socioeconomic and geographic contexts outside Ethiopia) from an implementation point of view.

Minor corrections (I do not need to review these changes again):

Fix typos in line numbers 40 (Prolonged should be prolonged), 193, 240, 280.

Line 104: 28 weeks and not 28th weeks, to be consistent with the definition of cases.

Line 111: Gave birth to babies, instead of delivered babies?

Add a note defining gravidity categories under table 1.

Line 200 reads awkward (male babies vs girls- use consistent terminology).

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Reviewer #1: No

Reviewer #2: No

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Determinants of Stillbirth among Women Who Delivered in Hospitals of North Wollo Zone, Northeast Ethiopia: A Case-Control Study.

PONE-D-23-22773R2

Dear Dr. Bizuneh,

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.

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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,

Abera Mersha, MSc.

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 #2: 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 #2: Yes

**********

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

Reviewer #2: I Don't Know

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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 #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 #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 #2: Thank you for making further changes in the manuscript in line with the reviewers' comments. We hope the findings of this paper will help the local health authorities in their planning.

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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 #2: No

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