Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04488276 |
| Other study ID # |
AC19107 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2019 |
| Est. completion date |
March 31, 2021 |
Study information
| Verified date |
June 2024 |
| Source |
University of Edinburgh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
More than 40% of all pregnant women in Pakistan are exposed to second-hand smoke - causing
approximately 17,000 still births in a year. In Pakistan only 1% of still births are
attributed to women actively smoking during pregnancy, but for second-hand smoke the figure
is 7%, largely due to the high numbers of pregnant women exposed to tobacco smoke in the
home. Negative effects of Second-hand smoking (SHS) on maternal and fetal health are well
established. In low and middle-income countries (LMICs) smoking inside the house is largely
unrestricted adversely affecting pregnant women by exposure to SHS. SHS exposure in
non-smoking pregnant women has increased the risk of stillbirth and congenital malformation
along with behavioural and cognitive issues in children. Partner's support during pregnancy
is important for developing a better maternal health. Therefore, a phenomenological research
approach is appropriate for describing the essence of experience in terms of affective and
emotional aspects. Phenomenology is an approach of creating phenomenological knowledge in a
situation by describing implicit meaning of experience. The investigators therefore propose
an epistemological approach of phenomenology.
Description:
INTRODUCTION:
Different forms of tobacco such as cigarettes, water pipe, chewing paan, gutka and naswar are
used in Pakistan. According to Global Adult Tobacco Survey (2014), overall prevalence of
tobacco use in Pakistan is 19.1% (23.9 million adults). 7 out of 10 adults and 5 out of 10
children are exposed to second hand smoke in indoor workplace and at home. Second hand smoke
(SHS) is strongly associated with exposure of non-smoking pregnant women to various toxicants
which can harm the fetus and post partum harm infants and children. Effects of second-hand
smoking during pregnancy include low birth weight, sudden infant death, acute and chronic
respiratory symptoms, asthma and ear infection . In South and Southeast Asia, women have a
higher rate of exposure to SHS than men whereby they are exposed in different places
disproportionality, such as public transportation (62%), restaurants (56%) and at workplace
(37%). In LMICs, smoking inside the home is unrestricted and pregnant women are adversely
affected by exposure to SHS which increases the risk of stillbirth and congenital
malformation. It is, therefore, important to avert negative consequences of pregnancies that
are exposed to second-hand smoke.
BACKGROUND:
Previously researchers have tried to explore societal and cultural aspects of indoor smoking
and exposure to SHS and attributed gender inequality and gendered power dynamics to women's
failure to negotiate smoke-free homes. Additionally, several interventions have been found to
be effective in changing smoking-related behavior, however, most do not provide think
description of interventions to ascertain their theoretical basis. Therefore, examining the
phenomenon of second-hand smoke with an in-depth understanding of social and cultural factors
may help in describing smoking- and anti-smoking related behavior through qualitative
exploration. Findings of this pioneering qualitative work can be utilized for designing an
effective reduction strategy for tobacco use which can act as a conceptual framework for
behavior change to reduce or eliminate the effects of second-hand smoke on pregnant women.
More than 40% of all pregnant women in Pakistan are exposed to second-hand smoke - causing
approximately 17,000 still births in a year. In Pakistan only 1% of still births are
attributed to women actively smoking during pregnancy, but for second-hand smoke the figure
is 7%, largely due to the high numbers of pregnant women exposed to tobacco smoke in the
home. Negative effects of Second-hand smoking (SHS) on maternal and fetal health are well
established. In LMICs smoking inside the house is largely unrestricted adversely affecting
pregnant women by exposure to SHS. SHS exposure in non-smoking pregnant women has increased
the risk of stillbirth and congenital malformation along with behavioral and cognitive issues
in children. Partner's support during pregnancy is important for developing a better maternal
health. Therefore, a phenomenological research approach is appropriate for describing the
essence of experience in terms of affective and emotional aspects. Phenomenology is an
approach of creating phenomenological knowledge in a situation by describing implicit meaning
of experience. The investigators therefore propose an epistemological approach of
phenomenology.
Informed by the findings of the systematic review on the risk perception of second-hand
smoke, an interview guide will be developed. Int depth interviews with expectant or new
fathers who smoke (n=25-30) and their pregnant or post-partum partners exposed to
SHS(n=10-15) will be conducted. Thematic analysis will then be done. In addition to
presenting findings of research in traditional manner (themes), they will also be presented
in more applied or ready-to-be-picked manner. It means that based on the findings of this
study an evidence-informed conceptual framework will be developed to propose a behavior
change communication intervention, which will target poor or risky behaviors to promote
behavior modification that may result in positive maternal and fetal health outcomes.
This will be a qualitative study incorporating an initial stage of systematic review followed
by a stage of in depth interviewing that will lead to development of the conceptual
framework.
METHODOLOGY:
Stage I:
Search Strategy:
Firstly, a review protocol will be developed(followed by its registration in (PROSPERO)
incorporating key terms and alternate search terms which are given below:
- Second hand smoke: Indirect smoke, involuntary smoke, passive smoke
- Perception: Opinion, Perspective, Experience
- Pregnancy: Pregnant woman, post-partum woman
These search terms will be used in different combinations to form search string with use of
Boolean operators (AND, OR) and truncations. PubMed, Embase, Global Health and CINAHL will be
searched systematically to identify and retrieve relevant data. Inclusion criteria are given
below:
- Qualitative studies or mixed method studies
- Studies covering perception of effects of SHS on pregnancy
Database Search:
Two independent reviewers will implement the search strategy and compile extracted data in
Microsoft Excel sheet. The PRISMA workflow will be employed to complete the search.
Quality Assessment:
Critical Appraisal Skills Programme (CASP) or Joanna Briggs Institute (JBI) tool will be used
to critically appraise the research studies. Two reviewers will appraise and report the
result independently.
Data Extraction:
Data will be extracted at two levels: first order construct (participant's quote) and second
order constructs (researcher's interpretation).
Data Synthesis and Reporting:
Extracted data will be assembled into collective findings which will explain the phenomenon
under study. The necessary information extracted from each included paper will be descriptive
(regarding the participants, study type and characteristics, location, setting, year, main
topic, etc.), methods, type of analysis, findings, and original quotations. Thematic analysis
of data will be employed. Double data extraction, which is considered the golden standard,
will be employed. As a first step initial codes according to the analytical approach will be
created. As the analysis progresses, it might be that some findings form a code, or they
might become a code combined with other findings. It might also require for some codes to be
collapsed in order to form another code or (sub)theme. The data, once compiled and analyzed,
will also be available for depositing and publishing on an open research data platform.
Stage 2:
Settings:
Study will be conducted in Urban and peri-urban settings of Rawalpindi district.
Research Design:
Our qualitative approach will include in depth interviewing.
Sampling:
Purposive sampling will be employed to select potential respondents from different
socio-economic and education background. Though number of respondents will be determined by
theoretical saturation, but for planning purpose the investigators will recruit 25-30 smokers
and 10-15 non-smoking pregnant or post-partum women.
Potential Respondents:
Community gatekeepers and lady health workers will be used to identify expectant and new
fathers, who are active smokers, along with pregnant and post-partum women who are exposed to
SHS.
Data Collection:
Interview guide will be developed deductively as a result of the systematic review and will
be piloted before its actual use. Guide will be revised based on the experience of pilot
interview or as data collection proceeds. Trained interviewer will conduct in-depth interview
using semi-structured interview guide and will record it with consent from respondents.
Later, services of professional transcriber and translator will be taken and data will be
coded by team of two researchers.
Data Analysis:
Inductive approach of extracting codes from the textual data will be utilized. Initial coding
structure will be developed and discussed and same will undergo several iterations based on
the review of other transcripts. Final coding scheme will be uniformly applied to all
interview transcripts. Inductive thematic analysis approach will be used to identify
behaviors and methods of behavior development. Narrative account on lived experiences will
help us to contextualize key behavior within cultural and social context of the Pakistan.
