Title: Prevalence, Safety Evidence, and Determinants of Medicine Use during Breastfeeding
among Women in Kampala, Uganda
Version: 2 Date: 25 May 2025
Reviewer's report:
Manuscript Number: Submission ID: e4bb3e86-5524-423d-9e1e-5c09568879c3
Title: Prevalence, Safety Evidence, and Determinants of Medicine Use during Breastfeeding
among Women in Kampala, Uganda
Reviewer:
General comments
This manuscript reports findings on medication use during breastfeeding among women in an
urban setting, Kampala, Uganda, and concludes that many breastfeeding women use medications
on a self-prescribed basis—which poses a potential risk to the infant. The manuscript therefore
addresses an important aspect of maternal child health with implications for infant well-being
and rational drug use. However, addressing the comments below would be helpful to improve
the manuscript.
Abstract
Results
Providing information on the postnatal ages of the infants would be important here.
Introduction
Going by the study results, it would be important to include a brief literature review on
breastfeeding in the context of HIV/AIDS in the introduction, including the current national
prevalence of HIV among pregnant and breastfeeding women.
Materials and methods
Study design and setting
From the description of the study setting, it gives an impression that this study was conducted
among women living with HIV; otherwise, a clear statement to this effect would be important.
Patient and public involvement
Line 110—The statement here seems to suggest that the study was piloted by peer mothers and
not the investigators. A clarity on this is necessary.
Eligibility and recruitment
While lines 123-124 give the eligibility for this study, the study population remains unclear, and
there is a need to first and foremost clearly define and describe the study population.
In the same lines, 123-124, the authors talk of women aged 18 years and older who had finished
breastfeeding in the past three months and whose infants were twelve months or younger.
- What do the authors mean by “finished breastfeeding?” Is this to mean ‘stopped breastfeeding?’
- As stated above, it means that infants stopped breastfeeding at nine months or younger (i.e.
#12 months minus 3 months). Please clarify what breastfeeding practice this is.
Lines 126-127—You state that “women with children more than twelve months of age were
excluded from the study.” However, this cannot again be an exclusion criterion, having only
included women with infants #12 months.
What was the purpose of MCH clinic attendance for these mothers? This would be important
for the reader and to put the study and its results in context.
What other considerations were made in the calculation of the sample size apart from the
assumption of 80% use of medicines?
Lines 137-139—Translation of the survey questions by the research assistants into the
participants’ preferred language at the point of conducting the survey would likely have
introduced variability and loss of consistency in the way the questions were asked by the different
research assistants to each participant. How was this overcome to ensure consistency?
Lines 145-146—The statements, “…(1) currently using medication while breastfeeding and
(3) not using any medication while breastfeeding,” do not make a lot of sense when the study
included women who finished breastfeeding in the past three months! Please clarify.
Statistical analysis
Were summary analyses for continuous variables performed – like mean (SD) and median (range
of IQR)? Then a description should be included in the statistical analysis statement.
Lines 156-157 should better be revised to read, “….model was fitted to identify factors
associated with medicine use among breastfeeding women,” and NOT “prevalence of
breastfeeding” as stated.
Lines 161-162: What do you mean by “…chronic condition (non-HIV) and HIV status?”
Results
Lines 186-187 & Table 1: Up to 39.5% of the women were living with HIV/AIDS;
- This is an unprecedented prevalence of HIV among breastfeeding women, exceedingly over
and above any national average! The authors need to justify and substantiate this finding.
- This finding reaffirms why it is important to clearly describe the study context and the study
population as earlier suggested. For instance, were these study sites HIV clinics, etc.?
- How was HIV status determined during the study? – Did you do HIV testing for those who
did not know their status, if any?
Table 1
- What is COI%?
- Marital status and employment categories—please account for the missing values. If unknown,
then state so.
- Contraception use—Please specify the timing in terms of use. Was it during breastfeeding?
Was it ever used? Etc.
Line 191 – It is important to include absolute number for the stated prevalence percentage.
In the same line 191, the prevalence of medication use is stated as 78.9% - which, from Figure
1, is a combination of “Currently on medication while breastfeeding (27.9%)” and “Ever taken
medication while breastfeeding (51.9%)”. However, in line 154-155, the authors had earlier
defined prevalence of medication use during breastfeeding as the proportion of participants who
were actively using medicines at the time of recruitment into the study. Can the authors please
clarify this?
Figure 1:
The last bar – is this the same as the 10% stated in the dissuasion?
Table 2
Footnote – please un-bold the texts and use a lower font
Table 3
It would help, if possible, to include a column of infant’s dose via milk and mother’s dose, from
which the calculated RIDs were derived.
Discussion
The sentence in line 312 should begin as a separate paragraph.
Lines 333-334 – the sentence, “For medications flagged….for 2-4 hour after administration,” is
a repetition of the sentence preceding it in lines 331-332. Please delete