| CTRI Number |
CTRI/2025/09/094219 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [birthing exercises] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to see how exercises during pregnancy affects the mode of delivery among pregnant women |
|
Scientific Title of Study
|
Effect of birthing exercises on mode of delivery among antenatal mothers at a tertiary care hospital, south India- A randomized control trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sujata Das |
| Designation |
M.Sc. Obstetrics and Gynecological Nursing Student |
| Affiliation |
College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry- 605006, Old Curie House, Room no- 213
Pondicherry
PONDICHERRY
605006
India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7001561325 |
| Fax |
|
| Email |
dassujata210@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Niksy Abraham |
| Designation |
Tutor |
| Affiliation |
College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Obstetrics and Gynecological Nursing, College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry- 605006
Pondicherry
PONDICHERRY
605006
India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8608553636 |
| Fax |
|
| Email |
renju.thms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Niksy Abraham |
| Designation |
Tutor |
| Affiliation |
College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Obstetrics and Gynecological Nursing, College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry- 605006
Pondicherry
PONDICHERRY
605006
India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8608553636 |
| Fax |
|
| Email |
renju.thms@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural fund Committee, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry- 605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry- 605006 |
| Address |
Intramural fund Committee, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry- 605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Gowri Dorairajan |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Department of Obstetrics and Gynecology, Antenatal OPD, Room no-03
Pondicherry
PONDICHERRY
Pondicherry
PONDICHERRY |
9894348518
gowridorai@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Interventional studies, Jawaharlal Institute of Postgraduate Medical Education and 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 |
| Intervention |
Birthing Exercises along with standardized routine care |
Selected birthing exercises will teach to antenatal mother during antenatal visit, exercises schedule 2 min warm up, followed by birthing exercises for 10-20 min, each exercises for 10 sec for either 2 to 3 times as per mothers preference and tolerability and also in between rest period and mothers are instructed to practice the same at home upto delivery |
| Comparator Agent |
standardized routine care |
routine antenatal checkup, and supplements |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Primigravida mother of 32 to 36 week of gestation
2.Singleton pregnancy
3.Vertex presentation |
|
| ExclusionCriteria |
| Details |
Presence of complication during pregnancy such as 1.hypertension
2.skeletal problem
3.heart disease
4.antepartum hemorrhage
5.medical prohibition to exercises during pregnancy |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the mode of delivery between birthing exercises group and control group |
After delivery within 24 hours of postpartum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="138"
Sample Size from India="138"
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)
|
22/09/2025 |
| 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) |
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
|
This study is a randomized control trial to assess the effect of birthing exercises on mode of delivery among antenatal mother who are coming to JIPMER antenatal OPD. Antenatal mother who meets the inclusion criteria are selected as a study participant by convenience sampling and assigned to the control and experimental group by block randomization with fixed block size, allocation will be done by SNOOSE method. Informed consent will be obtained from both the group and intervention will be given to the experimental group. Birthing exercises which include spinal mobility exercises - cat and camel exercise, hip mobility exercises - side lunging, forward lunging, grinding, butterfly exercise, pelvic rocking exercises and round ball exercises will be teach to the mother during their antenatal visit to OPD and will instruct them to practice the same exercise at home for 10 to 20 minutes per day for more than 3 days per week upto delivery . leaflet will be provide to the experimental group. Exercises adherence schedule follow up will be done through phone call and maintaining a dairy by the mothers. Finally, the mode of delivery will be assessed |