OB Journal Appraisal

BIALBA, Allison Mei R.
YL-3
Effect of population-based antenatal screening and treatment of genitourinary tract infections on

birth outcomes in Sylhet, Bangladesh (MIST): a cluster-randomised clinical trial
Introduction: The researchers kicked off the study with presenting evidences on the statistics of preterm
births attributed to pregnancy infections which are commonly undetected and untreated in low-income
and middle-income countries (LMICs) before the study was conducted. It was mentioned that
complications from preterm birth are now the leading cause of child mortality thus, effective strategies
are needed for primary prevention of preterm birth specifically ascending infection from the lower genital
tract. They utilized information from Cochrane review which presented studies wherein screening and
treatment of asymptomatic bacterial vaginosis in the general obstetric population did not reduce the risk
of preterm birth and pooled analysis that also presented the opposite wherein treatment with clindamycin
significantly reduced preterm births which is before 37 weeks. The researchers also gave a concise
overview of the pathophysiology and symptoms of bacterial vaginosis which is the most prevalent
reproductive tract infection in pregnancy globally. The objectives were clearly stated and direct to the
point. The study aimed to reduce the incidence of preterm birth thru implementation of community-based
intervention to screen and treat maternal genitourinary tract infections.
Methodology: The research used unblinded cluster-randomized controlled trial as their method to elicit
results. They conducted this in a rural area in Bangladesh wherein access to healthcare is poor but need is
high. The chosen area also has one of the highest rates of neonatal mortality in Bangladesh. a clinical trial
is a study design in which participants are randomly allocated to a test treatment and a control; involves
concurrent enrolment and follow-up of both groups; gold standard in testing the efficacy of an
intervention. The use of RCT in this study is advantageous given that it allows rigorous evaluation of a
single variable, potentially eradicate bias and allow for meta-analysis. A power calculation was also seen
in the study. This puts out a high chance of detecting a worthwhile effect if it exists. The large is thus
deemed useful in order to have a good chance of detecting a true difference between the intervention and
control groups.
Because of the nature of the intervention, I do think that unblinded method is appropriate in this RCT.
The trial intervention could not be masked to investigators or participants. However, it was stated that the
health workers and study participants were not aware of the study hypotheses as well as the outcome
measures. The researchers clearly stated the existing conditions of possible participants that they consider
not to include in the study. Informed consent was also obtained and the researchers secured the treatment
of data w/ strict confidentiality. The procedure and environment required to gather information were well
discussed and are concise. There was a mention of approval from institutional review board and presence
of data and safety monitoring which I deem important in all researches. The materials and procedures
used were also mentioned which gave the readers of the study a visual of how the home-based antenatal
care was performed including collection of vaginal swab and use of Nugent score in the laboratory. The
provision of treatment for the participants who yielded abnormal vaginal flora or UTI were also
mentioned. In addition to this, community health workers were notified of all pregnancy outcomes by
village health workers and completed home visits. Neonatal assessment were also performed.
Results: The researchers presented data thru a table depicting the screening and treatment among the
intervention cluster pregnancies and control subsample pregnancies. In a post-hoc analyses, the risk of
preterm delivery was significantly higher among women and girls with persistent abnormal vaginal flora
than among non-infected participants. The researchers adjusted their relative risk or risk ratio which is the
risk of the outcome occurring in the intervention group compared with the control group was adjusted for
age, wealth index and primiparity of participants. The study revealed that a population-based screening
and treatment intervention for maternal genitourinary tract infections in early pregnancy had no effect on
the incidence of preterm livebirths, or other pregnancy outcomes. Although the researchers initiated
antibiotic treatment in most infected women and attempted to retreat persistent infections, the overall
effective coverage of successful treatment was low. The lack of intervention effect was probably caused
by the low rates of effective treatment coverage and clinical cure achieved for both infections. Antibiotic
resistance and potential variation in the microbial composition of abnormal vaginal flora and host
immune responses in the studied population could have contributed to this lack of response. Although the
study had a null effect, the findings are important because they highlight the need to better describe the
local microbiology of these infections, to identify treatment with improved clinical efficacy, and to
develop alternative strategies to prevent preterm births in LMICs.
Conclusion: The researchers were able to answer the research question as were able to attain the
objectives of the study. In the trial, treatment of asymptomatic bacteriuria and urinary tract infections had
no effect on preterm birth or low birthweight. the researchers were able to mention the limitations the
study as well as recommendations that would further contribute to yield a more conclusive data. The
study findings highlight the need for further research to improve data for the epidemiology and
microbiology of abnormal vaginal flora and urinary tract infections. A need of characterization of the
vaginal microbiota of abnormal vaginal flora—and particularly of persistent abnormal vaginal flora—is
crucial to identify the specific subtypes associated with preterm birth and to help to better target screening
tools and develop treatments with improved clinical efficacy. In addition to this, additional research is
needed to study the role of other infections and risk factors for preterm birth that we did not consider in
our intervention. Lastly, there were no conflicts of interest noted in the study.
Relevance: The study conducted is relevant nowadays especially for those in areas where the study was
conducted. This material could be of use to researchers who want to conduct similar research on a larger
scale. This would also allow the government and the responsible agencies on maternal and neonatal
health to seek ways in order to achieve the best healthcare of which could avoid potential morbidity and
mortality. The study could also shed more light on the impact of maternal infections particularly UTI and
the importance of conducting screening and treatment in order to avoid preterm birth. Lastly, this research
could be a basis and guide for future researchers who might want to create an intervention regarding this
matter.

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BIALBA, Allison Mei R.

Effect of population-based antenatal screening and treatment of genitourinary tract infections on

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