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CTRI Number  CTRI/2024/09/073632 [Registered on: 09/09/2024] Trial Registered Prospectively
Last Modified On: 29/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [effect on duration of labour and labour outcome]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of standing up position on the duration of labour and its outcome among primigravida at term. 
Scientific Title of Study   Effect of upright position on the duration of active phase of first stage of labour and labour outcome among primigravida at term in a tertiary care hospital: A Randomised controlled 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  SHRITY BRAHAMAN 
Designation  STUDENT 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Jawaharlal Institute of Postgraduate Medical Education and Research MSc Nursing Obstetrics and Gynaecology department Gorimedu Dhanvantari Nagar Puducherry Room number 363 Nightingale hostel.

Pondicherry
PONDICHERRY
605006
India 
Phone  8918014832  
Fax    
Email  shrity.brahaman1998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mrs Niksy Abraham 
Designation  TUTOR 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research, Gorimedu Dhanvantari Nagar

Pondicherry
PONDICHERRY
605006
India 
Phone  8608553636  
Fax    
Email  renju.thms@gmail.com  
 
Details of Contact Person
Public Query  
Name  SHRITY BRAHAMAN 
Designation  Student 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research. 
Address  Jawaharlal Institute of Postgraduate Medical Education and Research.Msc Nursing Obstetrics and Gynaecology department Gorimedu Dhanvantari Nagar, room no 363 Nightingale hostel

Pondicherry
PONDICHERRY
605006
India 
Phone  8918014832  
Fax    
Email  shrity.brahaman1998@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 
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  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR Latha Chaturvedula   Jawaharlal Institute of Postgraduate Medical Education and Research   WCH Building Department of Obstetrics and Gynecology, JIPMER campus Road, 605006
Pondicherry
PONDICHERRY 		 9486008274

jipoghod@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instittute Ethics Committee for Human Studies, Jawaharlal Institute of Post Graduate Medical Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  side lying or supine position as per hospital protocol   One group will be given lying down or left lateral position as per hospital protocol throughout the active phase of the first stage of labour till 10cm cervical dilatation. 
Intervention  upright position during active phase of first stage of labour.  In one group primigravida with singleton fetus on spontaneous labour with 4-5cm cervical dilatation will receive upright positions like ( standing, walking, hip dangling, squatting, sitting on the birth ball, sitting on the birth ball and sitting on the mat ) every 30 minutes every hour and for remaining 30 minutes 15 minutes FHR and uterine contraction will be assessed and 15 minutes rest can be taken by sitting on the chair also every 4th hourly PV will be done till 10 cm cervical dilatation. 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  39.00 Year(s)
Gender  Female 
Details  Primigravida mother in spontaneous labour, singleton fetus with vertex presentation and 4-5cm cervical dilation at term. 
 
ExclusionCriteria 
Details  Primigravida with contracted pelvis, undergoing induction of labour or presenting with fetal deceleration. Primigravida with GDM, sever pre-eclampsia, eclampsia and fetal macrosomia. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of upright position on the duration of the active phase of the first stage of labour and labour outcome   Every 30 minutes in an hour till full cervical dilation upright position will be given  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the labour outcome (cervical dilatation, mode of delivery, degree of perineal tear, PPH, APGAR scoring, and admission to NICU) between the control and intervention group  4th hourly for cervical dilatation and other after delivery. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "82"
Final Enrollment numbers achieved (India)="82" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/09/2024 
Date of Study Completion (India) 14/12/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 This study is a randomised control trial to assess the effectiveness of the upright position on the duration of the active phase of the first stage of labour. Primigravida women who met the inclusion criteria were enrolled in the labour room using the convenience sampling method and a sequentially numbered, opaque, sealed envelope. Informed consent was obtained, and the procedure was performed. The baseline data was collected from both groups by using a socio-demographic proforma. In the experimental group, after taking consent Primigravida in spontaneous labor was given upright position (standing, hip dangling, walking, squatting, siting on birthing ball, sitting on the mat ) as long as women is comfortable for every 30min in an hour remaining 15min FHR and uterine contraction was assessed and for remaining 15min she took rest by sitting on the chair. After every 4 hours, PV was monitored and when she dilated to 7-8cm, for the remaining time she was made to sit on the chair till full cervical dilatation. The control group was asked to lie down in the left lateral or supine position as per hospital routine. FHR and uterine contraction was monitored for 15min in every 30min  duration. Routine PV was done every 4thhourly to check the cervical dilatation. After the delivery mode of delivery, degree of perineal tear, occurrence of PPH, APGAR scoring at 1min and 5min, and need for NICU admission were assessed. 
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