| CTRI Number |
CTRI/2020/05/025402 [Registered on: 28/05/2020] Trial Registered Prospectively |
| Last Modified On: |
22/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical study assessing the effect of yoga during pregnancy on weight gain of mother and psychological stress in pregnancy |
|
Scientific Title of Study
|
A Prospective randomized controlled trial to study the effect of prenatal yoga on maternal weight gain and psychological stress in pregnancy and its association with pregnancy outcomes: A Pilot study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deeksha |
| Designation |
Junior resident |
| Affiliation |
AIIMS Delhi |
| Address |
Obs and gynae
3rd floor academic building Aiims Delhi
East
DELHI
110029
India |
| Phone |
8941890702 |
| Fax |
|
| Email |
myidmywork@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Aparna Sharma |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Delhi |
| Address |
3086
Obs and gynae
3rd floor academic building Aiims Delhi
East
DELHI
110029
India |
| Phone |
8941890702 |
| Fax |
|
| Email |
kaparnasharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deeksha |
| Designation |
Junior Resident IN Obs and Gynae |
| Affiliation |
AIIMS Delhi |
| Address |
OBS AND GYNAE
3RD FLOOR ACADEMIC BUILDING AIIMS DELHI
East
DELHI
110029
India |
| Phone |
8941890702 |
| Fax |
|
| Email |
myidmywork@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Deeksha |
| Address |
3rd Floor Obs and Gynae
Aiims Delhi |
| Type of Sponsor |
Other [Self funded by investigator ] |
|
|
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 |
| Dr Deeksha |
Aiims Delhi |
ANC OPD 3RD FLOOR OBGYN DEPARTMENT Ansari Nagar East Aiims New Delhi
East
DELHI |
8941890702
myidmywork@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee for Post Graduate Research |
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 |
Routine Antenatal care |
Routine Antenatal Care as per Aiims Delhi ANC clinic |
| Intervention |
Yoga |
Yoga in pregnancy 8 yoga sessions , 4 during beginning and
4 during 3rd trimester over a period of 2 consecutive weeks
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1 Primigravida with no known feto-maternal high risk factor
2 Between 20-35 years of age
3 BMI between 18.5-25
4 16-20 weeks POG
|
|
| ExclusionCriteria |
| Details |
1 Any medical or surgical condition which precludes physical exercises
2 BMI>25 or <18.5
3 High risk pregnancies
4 Unwilling to participate in study
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of maternal weight gain
Assessment of psychological stress using perceived stress scale
|
Assessment of maternal weight gain
Assessment of psychological stress using perceived stress scale
At 28 wks and 36 wks of pregnancy
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
assessment of prenatal yoga on labour outcome using clinical records ;need for labour induction ,duration of pain ,requirement of analgesia ,labour augmentation ,mode of delivery
assessment of prenatal yoga on pulmonary function using PFT |
labor outcomes at the end of pregnancy
PFT assessment at baselne 28 and 36 wks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
31/05/2020 |
| Date of Study Completion (India) |
27/12/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
27/12/2021 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
under process |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A Prospective randomized controlled trial to study the effect of prenatal yoga on maternal weight gain and psychological stress in pregnancy and its association with pregnancy outcomes: A Pilot study
total recruit:120 patients study and control: 50 patients each Study duration: Dec 2019- Nov 2021
weight gain and perceived stress scale in control group was higher than in study group.
|