Chapter 2: Materials and Methods

2. MATERIALS AND METHODS

2.1 Study Design

The study design is a technique, plan or procedure for shaping a research and it provides an
opportunity to work on an idea and to predict the deficiencies and flaws in the research. By
having a good design of all parts of a research project can be made to work together in order
to get the desired results. There are two main types of study designs i.e. qualitative and
quantitative (Trochim, 2005). Quantitative can be further divided into experimental study and
observational study. An experimental study can be a randomized controlled trial or a Quasi-
Experimental design. Similarly, analytical and descriptive are two types of observational
study. An analytical study has further three types i.e. Cross-sectional, cohort and case-control
study. The present research project was a multicenter descriptive observational study (Baxter,
2008).

2.2. Study Setting

This study was planned to explore the prescribed management strategies (Tocolytics,
Antenatal corticosteroids, and Progesterone) in Pakistan to manage preterm labor and birth
and comparing them with previously existing data. It was conducted in the capital of
Pakistan, Islamabad. This setting was selected keeping in view the feasibility of data
collection in the city. The study was carried out in the maternity unit of different public and
private maternity units of Islamabad hospitals.

2.3. Study Duration

We carried out data collection for this research over a period of seven months after approval
of synopsis in September 2017. The data collection was done from September 2017 to March
2018. The data was collected by visiting different maternity units of primary, secondary and
tertiary care setups.

2.4. Sampling Procedure

2.4.1. Sampling technique

Non-probability, convenient purposive sampling was carried for throughout data collection.
Purposive sampling is the form of non-random sampling that requires, at a minimum
establishing

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criteria for who will be included in the sample, i.e., stating who will meet your purposive. In
contrast, convenience sampling is taking anyone who happens to be available (Ang SGM et
al., 2012).

2.4.2. Sample size:

Keeping in view the above-mentioned objective, the sample size during the time frame of
seven months i.e. September 2017 to March 2018 came out to be 207. Initially, 207
obstetricians approached for the study and questionnaires were distributed among them. Only
171 respondents returned the questionnaires. However, 9 (4.3%) questionnaires were not
filled with complete requirements. The incomplete questionnaire was excluded from the
study. 159 (77%) participants of the total sample were currently practicing obstetricians at the
time of the study (Ang SGM et al., 2012). Population size is unknown for statistically
sufficient sampling, all doctors in an obstetric department were approached and asked to
complete a questionnaire after a brief explanation (Thygesen and Ersbøll, 2014).

2.5. Sample Selection

Participants who were included in the study were physicians working in the gynecological
department of public and private hospitals. House staff working in the maternity units were
ineligible to take part in survey research, the reason behind is their lack of expertise as their
time period working in obstetric department varies from 1 to 3 months utmost. While the
post-graduate year two level, medical officers, consultant and above were eligible.
Participation was voluntary and participants received no financial incentives. Institutional
Review Board approved the survey and also by every study subjects underwent informed
consent (Thygesen and Ersboll, 2014).

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2.5.1. Inclusion criteria

- Participants who gave informed consent

- Obstetric and Gynecological consultants
- Obstetric and Gynecological postgraduate trainees
- Medical officers working in the Obstetric and Gynecological department

2.5.2. Exclusion criteria

- The ones who were not willing to participate

- The ones who were not currently practicing
- House officers, interns or medical students working in obstetrics and gynecological
departments

2.6. Data Collection

Data was collected using a standardized, structured, pre-tested questionnaire tool adapted from
previously published studies. Before starting the actual data collection process, a pilot study was
conducted on 10 participants to assess the reliability and validity of the questionnaire. All the
data was collected by each selected institution during working hours. Participants were assured
that no individual information regarding the interviews and data collection will be shared with
anyone and that this information will only be used for research purpose. The questionnaire was
given an identification number to maintain continuum and privacy. All data were entered on
Microsoft Excel. The data sheet formulated was thoroughly assessed for missing values,
duplications accordingly. Data from each questionnaire was analyzed descriptively. The whole
procedure was supervised by the principal investigator.

2.7. Data Collection Tool

A three-page self-administered survey was administered to 207 Obstetric and Gynecologic
fellows practicing in maternity units of Islamabad. The questionnaire was developed by
combining pre-validated questionnaires. Content and face validity of the tool was evaluated
developed using input from senior staff at the Quaid-i-Azam university, Monish University and
consultants from Pakistan Atomic Energy Commission (PAEC) and South East Hospital prior to
use as a tool to collect data. The questionnaire contained five demographic questions, 11

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questions on management choices of preterm labor i.e. use of Tocolytics for women with signs
and symptoms of preterm labor, use of repeat courses for cases in danger, one question on drug
side-effects, and three questions on health barriers experienced in management. It was pre-
determined that the survey would take five to ten minutes to complete. The survey was approved
for distribution by the Ethical Committee of the Quaid-i-Azam University.

2.8. Data Processing and Analysis

2.8.1. Data entry
The first step of data analysis is all the respondents’ information collected through formulated
questionnaire was coded into variables. With exception of name, the demographic profile of
study contributors was entered as categorical variables. Management of preterm labor was added
as continuous variables.

2.8.2. Data analyse

After completion of data entry to Microsoft Excel 2007, data was transferred to Statistical
Package for Social Science Software version 21 (SPSS) for Windows Version 10 (SPSS Inc,
Chicago, IL, USA). Statistical analyses were computed via this software. Frequency and
percentage distribution were calculated for all variables first combined and then individually.
Descriptive statistics were used to analyze the data obtained from the statements about
demographic and management strategies of preterm labor. the χ2 analysis was done for
categorical data comparisons of binary variables (Cook and Peek, 2004).

2.9. Research Ethics

Ethical Approval to conduct the research and clearance was obtained from an ethical review
committee of the Quaid-i-Azam International University, Islamabad, Pakistan. A formal
permission was taken from the supervisor. However, prior to enrolling the study participants, key
stakeholders involved in the study area i.e. the maternity units of those tertiary care hospitals
were not informed about the nature and objectives of the research. Participants were briefed
about study objective and procedures and informed consent was taken from the participant
before interview/questionnaire filling. It also makes sure the confidentiality and participating
characteristics would be maintained confidentially. Counseling services from experienced
therapists were given after interview and no other direct benefit was provided to the participant.

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The participants were informed to withdraw from the study at any point in time. The aims and
objectives of this study were briefly explained to the participants and they were also told that the
information would be used for research purposes.

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