| CTRI Number |
CTRI/2026/03/107113 [Registered on: 30/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing upright position and birthing ball techniques in labor; impact on maternal comforts and neonatal outcomes in Punjab. |
|
Scientific Title of Study
|
A Comparative Study to assess the effectiveness of upright position versus birthing ball during labor on maternal and newborn outcome among primi parturient mothers admitted in selected Hospital, Punjab |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Simranpreet kaur |
| Designation |
Student |
| Affiliation |
Mata Sahib Kaur College of Nursing |
| Address |
Mata Sahib kaur College of Nursing, Mohali, Punjab
Obstetrics and Gynecological Nursing
Patiala
PUNJAB
140301
India |
| Phone |
9041020587 |
| Fax |
|
| Email |
simranpreet1993.sk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kamlesh Rani |
| Designation |
Professor |
| Affiliation |
Mata Sahib Kaur College of Nursing |
| Address |
Mata Sahib kaur College of Nursing, Mohali, Punjab
Obstetric and Gynecological Nursing
Patiala
PUNJAB
140301
India |
| Phone |
9855808755 |
| Fax |
|
| Email |
kamalrubal2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Simranpreet kaur |
| Designation |
Student |
| Affiliation |
Mata Sahib Kaur College of Nursing |
| Address |
Mata Sahib kaur College of Nursing, Mohali, Punjab
Obstetric and Gynecological Nursing
Patiala
PUNJAB
140301
India |
| Phone |
9041020587 |
| Fax |
|
| Email |
simranpreet1993.sk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mata Kaushalya Hospital ,Patiala, Punjab, 147001
India |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil
|
| Type of Sponsor |
Other [] |
|
|
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 |
| Simranpreet kaur |
Mata Kaushalya Hospital,Patiala,Punjab |
Labour Room,Midwifery Led Unit,2nd floor, Obstetrical and Gynaecological Department
Patiala
PUNJAB
Patiala
PUNJAB |
9041020587
simranpreet1993.sk@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mata Sahib Kaur College of Nursing, Balongi ,Mohali. |
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 Ball |
Birthing Ball will uses as a tool for sitting upright on the Ball and leaning over the ball and circling or rolling hips provided to the Primi Parturient mothers in the first stage of labor.[Exercises will conducted once every hour for 20-30minutes during first stage when cervix had dilated 4cm} |
| Comparator Agent |
Upright Position |
Upright Position( Sitting, Standing, Walking ) to Primi Parturient mothers in first stage of labor.[Exercises will conducted once every hour for 20-30minutes during first stage when cervix had dilated 4cm} |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Primi Parturient in their 1ST stage of labor.
Primi Parturient who are in a natural process.
Primi Parturient with single live fetus in cephalic presentation |
|
| ExclusionCriteria |
| Details |
Primi Parturient with complicated pregnancy.
Women who are not willing to participate.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration Of labor |
Active Stage of Labor when Mother are at Full Term |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
General Health of Mother after delivery.
General Health of Baby after delivery.
|
Active Stage of Labor when Mother are at Full Term |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/04/2026 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
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 randomized controlled trial design and quantitative approach will used to assess the effects of upright position and birthing ball on the selected labor outcome among Primi parturient mothers at selected hospital in Punjab. The purposive sampling technique will used for the selection of samples and random allocation of samples using lottery method, will be use to assign 20 samples to the upright position, birthing ball and control groups. The finding of the study expected to reveal that the Upright position and Birthing ball are expected to reduce the duration of labor and both techniques likely to promote good maternal and newborn outcome. |