| CTRI Number |
CTRI/2025/02/080253 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
This study will find out how sleep habit, work or exercise at home or office work and problems during pregnancy are linked and affect women who are more than 7 months |
|
Scientific Title of Study
|
A descriptive study to determine the relationship between sleep quality, physical activity and danger signs during late pregnancy among the antenatal women visiting the tertiary referral hospital |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pema Wangchuk |
| Designation |
Student (MSc Nursing (OBG)) |
| Affiliation |
MCON, MAHE |
| Address |
Manipal college of Nursing (MCON), Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Department of Obstetric and Gynaecology, Manipal college of Nursing (MCON), Manipal Academic of Higher Education (MAHE), Manipal, Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
7259777534 |
| Fax |
|
| Email |
pemghal407@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonia R B DSouza |
| Designation |
Professor & HOD |
| Affiliation |
MCON, MAHE |
| Address |
Department of Obstetric and Gynaecology,
Manipal college of Nursing (MCON), Manipal Academic of Higher Education (MAHE), Manipal, Udupi, Karnataka
Department of Obstetric and Gynaecology,
Manipal college of Nursing (MCON), Manipal Academic of Higher Education (MAHE), Manipal, Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9844732883 |
| Fax |
|
| Email |
sonia.r@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonia R B DSouza |
| Designation |
Professor & HOD |
| Affiliation |
MCON, MAHE |
| Address |
Department of Obstetric and Gynaecology,
Manipal college of Nursing (MCON), Manipal Academic of Higher Education (MAHE), Manipal, Udupi, Karnataka
Department of Obstetric and Gynaecology,
Manipal college of Nursing (MCON), Manipal Academic of Higher Education (MAHE), Manipal, Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9844732883 |
| Fax |
|
| Email |
sonia.r@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of obstetric and Gynaecology, Kasturba Hospital, Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104, India |
|
|
Primary Sponsor
|
| Name |
Pema Wangchuk SELF |
| Address |
Manipal College of Nursing (MCON) Manipal Academy of Higher Education (MAHE) Madhava Nagar, Manipal, Karnataka India - 576104. Office Contact No. : 0820-2922902. |
| Type of Sponsor |
Other [M.Sc Nursing student 2nd Year] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Pema Wangchuk |
Kasturba Hospital |
Department of Obstetrics and Gynaecology, OBG outpatient department. women and child block
Udupi
KARNATAKA |
7259777534
pemghal407@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women in third trimester and are above 28 weeks of gestation.
Women who can understand, read, write & speak English.
|
|
| ExclusionCriteria |
| Details |
Women with oligohydramnios, polyhydramnios, Pregnancy induce hypertension (PIH), Cardio vascular disease, endocrine disorder such as thyroid disease, cancer, eclampsia & Gestational diabetic mellites (GDM). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the corelation among the key research variables (Sleep quality, pregnancy physical activities and danger signs |
after 4 weeks of data collection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="422"
Sample Size from India="422"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A descriptive study to determine the relationship between sleep quality, physical activity and danger signs during late pregnancy among the antenatal women visiting the tertiary referral hospital.
· ·
Findings from
this study could guide healthcare providers in offering tailored advice and
interventions to improve the health and well-being of pregnant women. Results may
inform health promotion strategies aimed at improving sleep quality, promoting
healthy dietary habits, and encouraging appropriate physical activity levels
during late pregnancy. I.
To determine the sleep quality in late
pregnancy among antenatal women by using Pittsburgh Sleep Quality Index (PSQI) II.
To assess the physical activity
experienced by antenatal women in late pregnancy by using Pregnancy Physical
activity questionnaire (PPAQ). III.
To assess the danger signs during late
pregnancy among antenatal women by using self-reported danger signs tool.
IV.
To find the relationship between sleep
quality, physical activity and danger signs during late pregnancy among
antenatal women. There is a significant relationship between sleep quality, physical activity, and danger signs during late pregnancy among antenatal women visiting the tertiary referral hospital.
|