Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05777382 |
| Other study ID # |
131(6-N-E)2/075/076 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 12, 2018 |
| Est. completion date |
April 15, 2019 |
Study information
| Verified date |
March 2023 |
| Source |
Tribhuvan University, Nepal |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Objectives: Assessing health-related quality of life (HRQoL) and its predictors is essential
for providing adequate healthcare and developing necessary interventions in women
post-delivery. This study intended to determine the HRQoL score and predictors among women
post-delivery in Nepal.
Methodology: This was a cross-sectional study using non-probability sampling conducted at the
Maternal and Child Health (MCH) Clinic of Koshi Hospital, Province 1, Nepal. The study
participants were 129 women post-delivery to 12 months who visited the MCH clinic from 2
September 2018 to 28 September 2018. Outcome measures were socio-demographic, clinical
indicators, obstetric indicators, and their relation with overall health-related quality of
life score of post-delivery mothers using Short Form Health Survey (SF-36) Version 1.
Description:
This cross-sectional study involved women post-delivery to 12 months who visited the Maternal
and Child Health (MCH) Clinic of Koshi Hospital, Province 1, Nepal. The study population
included the mothers who attended the MCH clinic from post-delivery to 12 months
post-delivery. Mothers with psychiatric disorders were excluded from the study population.
The investigators used a non-probability purposive sampling technique to select mothers
meeting the inclusion criteria. The investigators used Short Form Health Survey (SF-36)
Version 1.0 to assess study participants' HRQoL after obtaining permission for Research and
Development (RAND). RAND SF-36 was already validated for use in Nepal by Bhandari et al.
However, the investigators again pretested the translated Nepali SF-36 among 13 mothers in
the MCH Clinic of Tribhuvan University Teaching Hospital. Cronbach's alpha was used to test
the reliability, and the reported value was 0.752. Patient participants were involved in the
study's pretesting. However, there was no public involvement in the research.
Independent variables: Age of mother, education status, ethnicity, religion, occupation,
family income, type of family, family support, parity, number of living children, the
desirability of pregnancy, mode of delivery, postpartum duration, place of delivery, and
complications in recent delivery.
Dependent variable: Overall health-related quality of life score of post-delivery mothers
were used.
Data was collected through face-to-face interviews using the RAND SF-36 Nepali version
questionnaire from 2 September 2018 to 28 September 2018. The investigators collected a total
of 129 responses. Descriptive statistics, i.e., number, percentage, mean, and standard
deviation, were used to describe the demographic and obstetric variables. Mann-Whitney U test
was applied to compare postnatal mothers' quality of life in different delivery modes.
Similarly, Krushkal-Wallis H and Mann-Whitney U tests were used to examine the difference
between the quality of life of postnatal mothers with selected socio-demographic and
obstetric variables. Statistical significance was considered with a p-value ≤ 0.05.
