| CTRI Number |
CTRI/2025/12/098521 [Registered on: 05/12/2025] Trial Registered Prospectively |
| Last Modified On: |
05/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of integrated yoga on labor outcomes - A prospective comparative study |
|
Scientific Title of Study
|
Effect of integrated yoga on labor outcome-A prospective comparative study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chaitali Anant Patil |
| Designation |
Junior resident |
| Affiliation |
Blde (deemed to be university) |
| Address |
Shri BM Patil Medical College Hospital and Research CenTRE, Solapur Road Vijayapura Karnataka 586103
Department of Obstetrics and Gynaecology
Bijapur
KARNATAKA
586103
India |
| Phone |
7276938328 |
| Fax |
08352262770 |
| Email |
chaitalip25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shreedevi Kori |
| Designation |
Associate Professor |
| Affiliation |
Blde (deemed to be university) |
| Address |
Shri BM Patil Medical College Hospital and Research Centre, Road Vijayapura Karnataka 586103
Department of Obstetrics and Gynaecology
Bijapur
KARNATAKA
586103
India |
| Phone |
9538846839 |
| Fax |
08352262770 |
| Email |
shree_kori@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shreedevi Kori |
| Designation |
Associate Professor |
| Affiliation |
Blde (deemed to be university) |
| Address |
Shri BM Patil Medical College Hospital and Research Centre ,Solapur Road Vijayapura Karnataka 586103
Department of Obstetrics and Gynaecology
Bijapur
KARNATAKA
586103
India |
| Phone |
9538846839 |
| Fax |
08352262770 |
| Email |
shree_kori@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shri B M Patil Medical College Hospital & Research Centre |
| Address |
Shri B M Patil Medical College Hospital & Research Centre Smt Bangaramma Sajjan Campus Solapur Road Vijayapur Karnataka 586103 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SHREE B M PATIL MEDICAL COLLEGE AND RESEARCH CENTRE |
Shri B M Patil Medical College Hospital & Research Centre Smt Bangaramma Sajjan Campus Solapur Road Vijayapur Karnataka 586103 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shreedevi Kori |
blde (deemed to be university) |
Shri B M Patil Medical College Hospital and Research Centre
B M Patil Road(Solapur Rd) Bangaramma Sajjan Campus Vijayapura Karnataka 586103 Department of Obstetrics and Gynaecology
Bijapur
KARNATAKA |
9538846839
shree_kori@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituional Ethical Commiitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O750||Maternal distress during labor anddelivery, (2) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
integrated |
Once patient was admitted in labour to our labour room, her last session of integrated yoga will be done up to 4 cm dilation in labour room the patients female attenders will be trained for conducting yoga. |
| Intervention |
integrated yoga |
Primigravida women directly coming to labour and fulfils our inclusion criteria will also be included in the study and who at term will also be taught integrated yoga. |
| Intervention |
integrated yoga |
The control group received the routine prenatal care that all pregnant women receive. In the intervention group the yoga module included prayer loosening practices asanas pranayama and meditation for 50 min. |
| Intervention |
integrated yoga |
The participants in the intervention group started the first session of pregnancy yoga from the 37th weeks of pregnancy and attended the last session before the labour up to 4cm cervical dilatation. |
| Intervention |
integrated yoga |
They exercised yoga once daily (each session lasting 50 min) at 37weeks of gestation to 4cm cervical dilation. follow up done using telephonic communication. |
| Intervention |
interated yoga |
All the patients who consented for study were randomised according to computerised simple randomisation chart. |
| Comparator Agent |
nil |
nil intervention done |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Maternal age of 18 years of age and above
Primigravida
Singleton pregnancy
Gestational age of 37 weeks and above in latent labor |
|
| ExclusionCriteria |
| Details |
Medical disorders/surgical comorbidities present
History of neuropsychiatric disorders
Intrauterine fetal complications present like Intra uterine growth restriction. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A Relief of pain by VAS. b Duration of labour by WHO LABOR CARE GUIDE (latent and active phases) |
After the delivery of the baby i.e 37 weeks - 40 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a. Mode of delivery (vaginal or caesarean section)
b. Maternal stress, anxiety, & pain perception (using standardized questionnaires)
|
37 weeks-40 weeks |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
16/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The objectives of my study are to examine the effects of integrated yoga on the intensity of labor pain, to evaluate the effectiveness of integrated yoga on reduction of the duration of labour, to study the mode of delivery. Study will be conducted on all Pregnant Women with Gestation Age Of 37 Weeks Seen in The Antenatal Clinic at The Department of Obstetrics and Gynaecology in tertiary health care setup that is at B.L.D.E (Deemed to Be University) Shree B.M. Patil Medical College and Hospital and Research Centre, Vijayapura, Karnataka, India. The sample Sample Size is 150 Primi Parturient (Group 1 – 75 And Group 2- 75) a randomised control trial. the duration of study will be from april 2025 to june 2027.
My inclusion criteria is as follows: Maternal age more than 18 years Primigravida Singleton pregnancy Gestational age of 37 weeks till in active labor upto 4 cm dilated cervix.
Exclusion criteria Medical disorders/ surgical comorbidities present History of Neuropsychiatric disorders Intra uterine fetal complications present like IUGR
All the patients who consented for study were randomised according to computerised simple randomisation chart. The participants in the intervention group started the first session of pregnancy yoga from the 37th weeks of pregnancy and attended the last session before the labour up to 4cm cervical dilatation. They exercised yoga once daily (each session lasting 50 min) at 37weeks of gestation to 4cm cervical dilation. follow up done using telephonic communication.
Once patient was admitted in labour to our labour room, her last session of integrated yoga will be done up to 4 cm dilation in labour room the patients female attenders will be trained for conducting yoga. Primigravida women directly coming to labour and fulfils our inclusion criteria will also be included in the study and who at term will also be taught integrated yoga,
The control group received the routine prenatal care that all pregnant women receive. In the intervention group, the yoga module included prayer, loosening practices, asanas, pranayama and meditation for 50 min. |