Author’s response to reviews
Title: Selective episiotomy vs. implementation of a non-episiotomy protocol: A randomized
clinical trial
Authors:
Melania Amorim ([email protected])
Isabela Coutinho ([email protected])
Inês Melo ([email protected])
Leila Katz ([email protected])
Version: 1 Date: 21 Mar 2017
Author’s response to reviews:
Point-to-point responses to reviewers
Dear reviewers:
With respect to your comments and suggestions, we are answering point-to-point copying your
reports as we retrieved from the editorial Manager: our answers are highlighted in red in the
attached file (response to reviewrs). We wait we have addressed our the relevant points. Thanks
for your patient and carefully reviews.
Sincerely,
Melania Amorim, MD, PhD
Reviewer reports:
Reviewer #1: The following comments are noted:
ABSTRACT- Under methods the group of women selected for the study is not clear as only the
exclusion criteria is written here.
Answer: in fact it was a typing error and the women were INCLUDED. It was corrected in the
current version. Thanks for your attention.
METHODS- the sentence in page 8, lines 21-22 regarding visual pain scale should be referenced
Answer: we had mentioned the references (10,11) in page 9 when explaining how was used the
visual pain scale but we added the references also in the line 22 of page 8, as you requested.
Thanks.
Reviewer #2: Dear authors, this study is an important issue in obstetric and is designed very well.
I enjoyed reading it. But please answer these question:
Abstract
Methods
1. It seems this sentence is related to incl
full-term live foetus, dilatation of 6 to 8 cm and cephalic presentation (vertex position) were
excluded.
Answer: thanks for your attention, it was a typing error and these women were INCLUDED. We
corrected this point in the new version (see the Abstract). Thanks for your attention.
Results
1. It is not necessary to writhe about the exclusion and dividing of samples in the result section in
the abstract. "Of the 241 women enrolled, four were excluded because of a postrandomization
indication for a caesarean section. Of the remaining 237, 115 were assigned to a non-episiotomy
protocol and 122 to selective episiotomy."
Answer: we have ommited the information about the exclusions and wrote a new, more concise
sentence. Please see the new version, Results of the Abstract (page 2).
Background
1. Line 3:Please use the word of " fetal" not foetal . This false word was used several times in the
text.
Answer: Thanks for your attention. We could identify other words that are more commonly used
in British English and substituted this and other words using American English: fetal, labor and
favors instead of foetal, labour and favours. Please let us know if more corrections are necessary.
2. The necessity of the study properly expressed. But similar studies have not been used and the
weaknesses of the studies must also be shown.
Answer: Thanks for your suggestion. We added a sentence in the Backgroud to comment the
weakness of the studies (Page 6). In the new version, we wrote: “A review of the Medline,
Lilacs/SciELO, EMBASE and Scopus databases and of the Cochrane Library using the
keywords “episiotomy” and “vaginal delivery” in Portuguese, English and Spanish, with the
filters “randomized clinical trials” and “systematic review”, failed to reveal any randomized
clinical trials on the subject of not performing episiotomy during vaginal delivery. All the trials
published in the literature compare selective versus routine episiotomy and they were not
designed to assess the need for episiotomy in any clinical setting 5. This is an inherent limitation
for its interpretation.”
Methods
1. The version of the Epi Info statistical software program was 7.1.5.or 2.3? Please explain about
this program in one sentence.
Answer: The correct version is 7.2, we corrected the information and explained about the
program (Page 10) in one sentence. Thanks for you suggestion.
2. How and when were evaluated the secondary maternal outcomes related to the perineal
trauma; complications with perineal suturing? The wound infection have to evaluate in five and
ten days after delivery
Answer: The patients were evaluated in the first 48 hours after delivery and then they returned to
a postnatal consultation 10 days after delivery. They were informed they could return before this
scheduled appointment to the hospital if they felt it was necessary (suspecting for any
complications). The perineal region was evaluated by a health professional (CNM or
obstetrician). We added a paragraph to explain this in the Methods section (see Pages 9 and 10).
Thanks for your attention.
3. Please explain how did you measure the blood loss in the first hour postpartum? You
mentioned blood was collected using specially adapted plastic bags. But didn't writhed did you
measure the amount of blood loss.
Answer: All these bags as well as the sponges and gazes used were then weighted and the blood
loss (expressed in milliliters – ml) was measured by discounting the previously determined dry
weight. This information was added to the new version of the manuscript (Page 9). Thanks for
your attention.
Results
1. In the results you mentioned the secondary maternal outcomes related to the perineal trauma
such as infection was similar. But how did you evaluated the perineal infection in 24 and 48
hours with confidence?
Answer: We think that with the new information added to the Methods section explaining the
different moments for perineal region evaluation we can explain better when and how was the
follow-up for these outcomes. Thanks for your attention.
Discussion
1. Discussion of this study is written well but pay attention to the weaknesses of other
studies
2. Comparison the results of opposed Study with your study.
Answer to 1 and 2: We added more comments to the weaknesses of other studies, both
observational about never performing episiotomy and randomized clinical trials that only
compared “selective” versus routine episiotomy. Please see the current version of the manuscript
(a new paragraph, Page 16, starting with “Notwithstanding, all above mentioned studies were
…). Thanks for your patient review and suggestions.
Point-to-point responses to reviewers
Dear reviewers:
With respect to your comments and suggestions, we are answering point-to-point copying your
reports as we retrieved from the editorial Manager: our answers are highlighted in red. We wait
we have addressed our the relevant points. Thanks for your patient and carefully reviews.
Sincerely,
Melania Amorim, MD, PhD
Reviewer reports:
Reviewer #1: The following comments are noted:
ABSTRACT- Under methods the group of women selected for the study is not clear as only the
exclusion criteria is written here.
Answer: in fact it was a typing error and the women were INCLUDED. It was corrected in the
current version. Thanks for your attention.
METHODS- the sentence in page 8, lines 21-22 regarding visual pain scale should be referenced
Answer: we had mentioned the references (10,11) in page 9 when explaining how was used the
visual pain scale but we added the references also in the line 22 of page 8, as you requested.
Thanks.
Reviewer #2: Dear authors, this study is an important issue in obstetric and is designed very well.
I enjoyed reading it. But please answer these question:
Abstract
Methods
1.
full-term live foetus, dilatation of 6 to 8 cm and cephalic presentation (vertex position) were
excluded.
Answer: thanks for your attention, it was a typing error and these women were INCLUDED. We
corrected this point in the new version (see the Abstract). Thanks for your attention.
Results
1. It is not necessary to writhe about the exclusion and dividing of samples in the result section in
the abstract. "Of the 241 women enrolled, four were excluded because of a postrandomization
indication for a caesarean section. Of the remaining 237, 115 were assigned to a non-episiotomy
protocol and 122 to selective episiotomy."
Answer: we have ommited the information about the exclusions and wrote a new, more concise
sentence. Please see the new version, Results of the Abstract (page 2).
Background
1. Line 3:Please use the word of " fetal" not foetal . This false word was used several times in the
text.
Answer: Thanks for your attention. We could identify other words that are more commonly used
in British English and substituted this and other words using American English: fetal, labor and
favors instead of foetal, labour and favours. Please let us know if more corrections are necessary.
2. The necessity of the study properly expressed. But similar studies have not been used and the
weaknesses of the studies must also be shown.
Answer: Thanks for your suggestion. We added a sentence in the Backgroud to comment the
weakness of the studies (Page 6). In the new version, we wrote: “A review of the Medline,
Lilacs/SciELO, EMBASE and Scopus databases and of the Cochrane Library using the
keywords “episiotomy” and “vaginal delivery” in Portuguese, English and Spanish, with the
filters “randomized clinical trials” and “systematic review”, failed to reveal any randomized
clinical trials on the subject of not performing episiotomy during vaginal delivery. All the trials
published in the literature compare selective versus routine episiotomy and they were not
designed to assess the need for episiotomy in any clinical setting 5. This is an inherent limitation
for its interpretation.”
Methods
1. The version of the Epi Info statistical software program was 7.1.5.or 2.3? Please explain about
this program in one sentence.
Answer: The correct version is 7.2, we corrected the information and explained about the
program (Page 10) in one sentence. Thanks for you suggestion.
2. How and when were evaluated the secondary maternal outcomes related to the perineal
trauma; complications with perineal suturing? The wound infection have to evaluate in five and
ten days after delivery
Answer: The patients were evaluated in the first 48 hours after delivery and then they returned to
a postnatal consultation 10 days after delivery. They were informed they could return before this
scheduled appointment to the hospital if they felt it was necessary (suspecting for any
complications). The perineal region was evaluated by a health professional (CNM or
obstetrician). We added a paragraph to explain this in the Methods section (see Pages 9 and 10).
Thanks for your attention.
3. Please explain how did you measure the blood loss in the first hour postpartum? You
mentioned blood was collected using specially adapted plastic bags. But didn't writhed did you
measure the amount of blood loss.
Answer: All these bags as well as the sponges and gazes used were then weighted and the blood
loss (expressed in milliliters – ml) was measured by discounting the previously determined dry
weight. This information was added to the new version of the manuscript (Page 9). Thanks for
your attention.
Results
1. In the results you mentioned the secondary maternal outcomes related to the perineal trauma
such as infection was similar. But how did you evaluated the perineal infection in 24 and 48
hours with confidence?
Answer: We think that with the new information added to the Methods section explaining the
different moments for perineal region evaluation we can explain better when and how was the
follow-up for these outcomes. Thanks for your attention.
Discussion
1. Discussion of this study is written well but pay attention to the weaknesses of other
studies
2. Comparison the results of opposed Study with your study.
Answer to 1 and 2: We added more comments to the weaknesses of other studies, both
observational about never performing episiotomy and randomized clinical trials that only
compared “selective” versus routine episiotomy. Please see the current version of the manuscript
(a new paragraph, Page 16, starting with “Notwithstanding, all above mentioned studies were
…). Thanks for your patient review and suggestions.