| CTRI Number |
CTRI/2025/07/091459 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Study of maternal and perinatal outcome in alternative birthing positions at Dr. Vitthalrao Vikhe Patil Pravara Rural Hospital, Loni |
|
Scientific Title of Study
|
Comparative study of maternal and perinatal outcome in Supine, Semi-recumbent, Squatting & Sitting birthing positions-A Factorial Randomized trial at Dr. Vitthalrao Vikhe Patil Pravara Rural Hospital, Loni |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parikshit Shantaram Jondhale |
| Designation |
Doctor Senior Resident |
| Affiliation |
Dr.Balasaheb Vikhe Patil Rural Medical College, Loni |
| Address |
Department of Obstetrics and Gynecology.
Dr.Vitthalrao Vikhe Patil Pravara Rural Hospital, Loni ,attached to Dr.Balasaheb Vikhe Patil rural Medical College, Loni, Ahmednagar District, Maharashtra
OPD no 102 Department of Obstetrics and Gynecology.
PIMS-DU Loni
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9822892285 |
| Fax |
|
| Email |
drparikshit99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidyadhar B Bangal |
| Designation |
Head Of the Department |
| Affiliation |
Dr.Balasaheb Vikhe Patil Rural Medical College, Loni |
| Address |
Department of Obstetrics and Gynecology.
Dr.Vitthalrao Vikhe Patil Pravara Rural Hospital, Loni ,attached to Dr.Balasaheb Vikhe Patil rural Medical College, Loni, Ahmednagar District, Maharashtra
OPD no 102 Department of Obstetrics and Gynecology.
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9145154778 |
| Fax |
|
| Email |
vbb217@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parikshit Shantaram Jondhale |
| Designation |
Doctor Senior Resident |
| Affiliation |
Dr.Balasaheb Vikhe Patil Rural Medical College, Loni |
| Address |
Department of Obstetrics and Gynecology.
Dr.Vitthalrao Vikhe Patil Pravara Rural Hospital, Loni ,attached to Dr.Balasaheb Vikhe Patil rural Medical College, Loni, Ahmednagar District, Maharashtra
OPD no 102 Department of Obstetrics and Gynecology.
PIMS-DU, Loni
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9822892285 |
| Fax |
|
| Email |
drparikshit99@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrVitthalrao Vikhe Patil Pravara Rural Hospital Loni |
| Address |
Dr.Vitthalrao Vikhe Patil Pravara Rural Hospital, Loni ,attached to Dr.Balasaheb Vikhe Patil rural Medical College, Loni, Ahmednagar District ,Maharashtra India
413736
|
| Type of Sponsor |
Private medical college |
|
|
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 Parikshit Jondhale |
Dr.Vitthalrao Vikhe Patil Pravara Rural Hospital, Loni |
Department of Obstetrics and Gynecology.
Dr.Vitthalrao Vikhe Patil Pravara Rural Hospital, Loni ,attached to Dr.Balasaheb Vikhe Patil rural Medical College, Loni
Ahmadnagar
MAHARASHTRA |
9822892285
drparikshit99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC PIMS-DU Loni |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O758||Other specified complications of labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Birthing positions
Supine position
Semi Recumbent position |
Supine position-
The supine position is when a woman gives birth on her back, it is the most common birthing position. The woman lies on her back with her knees bent & legs apart.
Semi Recumbent position-
Women can be in reclined bed with bed with an angle of 30-45 degree or She can sit on a reclining chair.
|
| Comparator Agent |
Squatting Position
Sitting Position |
Squatting Position: Holding a squatting bar on labor table
Sitting Position: Sitting on labor chair |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Term pregnancies more than 37 weeks up to 40 weeks
Primigravida and Multigravida
No contraindications for vaginal delivery
Low risk pregnancies
Women who will give written consent to participate in study
|
|
| ExclusionCriteria |
| Details |
High-risk pregnancies (e.g., preeclampsia, fetal distress)
Multiple gestations
Previous cesarean section
Preterm and post-dated pregnancies
Women who will undergo caesarean section during trial of normal delivery
Women who will not be ready to give informed written consent
Women who changes position during final stage of labor
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Episiotomy rate
Perineal tear rate
Cervical tear rate
Caesarean section rate
Third stage labour complications
Duration of second stage
Duration of third stage
Instrumental delivery rate
Birthing experience
Maternal mortality
Perinatal variables
APGAR score
Meconium aspiration
Birth Trauma
Need for NICU admission
Infective morbidity
Shoulder dystocia
Still birth
Birth weight
Neonatal mortality
Duration of hospital stay
|
from Process of active labor till 24 Hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Age
Parity
Booked status
Education
Maternal Height
Maternal weight
Body mass index
|
15 days |
|
|
Target Sample Size
|
Total Sample Size="800"
Sample Size from India="800"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/08/2025 |
| 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="1"
Months="0"
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
|
|