| CTRI Number |
CTRI/2022/03/041229 [Registered on: 21/03/2022] Trial Registered Prospectively |
| Last Modified On: |
16/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Yoga for Pregnancy in Bangladesh |
|
Scientific Title of Study
|
Knowledge, Acceptability and Efficacy of Antenatal Yoga in Bangladesh |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Satyapriya Maharana |
| Designation |
Associate Professor |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana |
| Address |
Prashanti Kutiram, Exam Department, Swami Vivekananda Rd Kalluballu Post, Anekal, Jigani, Bangaluru, Karnataka
Bangalore
KARNATAKA
560105
India |
| Phone |
8618587448 |
| Fax |
|
| Email |
satya.priya@svyasa.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Farhana Sultana Karim |
| Designation |
PhD Sholar |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana |
| Address |
Prashanti Kutiram, Bhooma- 7, Swami Vivekananda Rd, Kalluballu Post, Anekal, Jigani, Bangaluru, Karnataka
Holy Family Red Crescent Medical College Hospital ,1, Eskatan Garden Road,Moghbazar, Dhaka, Bangladesh
Bangalore
KARNATAKA
560105
India |
| Phone |
9318409268 |
| Fax |
|
| Email |
fsk.svyasa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shahin Rahman Chowdhury |
| Designation |
Head of the Dept. (Gyn ad Obs) and Co-Research Supervisor |
| Affiliation |
Holy Family Red Crescent Medical College Hospital |
| Address |
Department of Obstetrician and Gynecologist, Holy Family Red Crescent Medical College Hospital,1, Eskatan Garden Road,
Moghbazar, Dhaka, Bangladesh
1000
Other |
| Phone |
8801819145492 |
| Fax |
|
| Email |
shahinrahmanc@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Holy Family Red Crescent Medical College Hospital,1, Eskatan Garden Road, Moghbazar, Dhaka, Bangladesh |
|
|
Primary Sponsor
|
| Name |
Swami Vivekananda Yoga Anusandhana Samsthana |
| Address |
Prashanti Kutiram, Vivekananda Road, Kalluballu Post, Jigani, Anekal, Bengaluru – 560105, INDIA |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Holy Family Red Crescent Medical College Hospital |
1, Eskatan Garden Road, Moghbazar, Dhaka, Bangladesh |
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shahin Rahman Chowdhury |
Holy Family Red Crescent Medical College Hospital |
Department of Obstetrician and Gynecologist, 1, Eskatan Garden Road, Moghbazar, Dhaka, Bangladesh
|
8801819145492
shahinrahmanc@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Holy Family Red Crescent Medical College Hospital |
No Objection Certificate |
| Institutional Ethics Committee- SVYASA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
As per the usual recommendation of Gynecologist. |
| Intervention |
Yoga group |
Intervention will be 6 months. A validated yoga module is going to be used. Sessions will be in offline in the 1st month -1 hr per day, 3 days per week. Then the classes will be taken online.The classes will be designed into two separate groups- 2nd trimester and the third trimester. Yoga Module will be different depending on different trimesters. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Normal pregnancies registered for an antenatal check-up between 18- 20 weeks of gestation
Either primigravida or multigravidae with at least one live child through a normal previous delivery
Not exposed to Yoga
No physical or mental disability according to the doctor’s written diagnosis |
|
| ExclusionCriteria |
| Details |
Suffering from Chronic diseases like diabetes, hypertension, psychiatric illness, etc
Multiple pregnancies (twins, triplets, etc
IVF (In vitro fertilization) pregnancy
Maternal physical abnormalities
Previous bad obstetric history
Fetal abnormality detected in 20th-week scanning
Previous exposure to Yoga or vigorous physical exercises |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Labor Outcome |
At the time of Delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intra Uterine Growth
Sleeping pattern
Pregnancy-induced back pain
Stress
Anxiety
Depression
Quality of life |
20th week and 36th week |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="0"
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)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/06/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [fsk.svyasa@gmail.com].
- For how long will this data be available start date provided 25-03-2024 and end date provided 25-03-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a randomised, outcome accessor blind, parallel-group trial. The effect of yoga intervention is going to be checked on pregnant women. The primary outcome will be the Labour outcome that will be measured at the time of delivery. The secondary outcomes are Intra Uterine Growth, Sleeping pattern, Pregnancy Induced Back Pain, Stress, Depression, Quality of life that will be measured at the 20th week and 36 the week of pregnancy. |