FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/04/041740 [Registered on: 08/04/2022] Trial Registered Prospectively
Last Modified On: 15/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Other 
Public Title of Study   A Clinical Trial to Determine the Effects of Upright Position on Labour Outcomes. 
Scientific Title of Study   A Randomized Controlled Trial to Determine the Effects of Upright Position on Selected Labour Outcomes among Pregnant Women at Selected Hospitals of, Punjab. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vijeta Attri 
Designation  student  
Affiliation  BFUHS 
Address  Saraswati Nursing Institute, (Gynae Department, Ground floor, Room No.- 8) Dhianpura (Kurali) Punjab

Rupnagar
PUNJAB
140103
India 
Phone  9736523876  
Fax    
Email  vijetaattri1998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Kamlesh Rani  
Designation  Professor  
Affiliation  BFUHS 
Address  Saraswati Nursing Institute, (Gynae Department, Ground Floor, Room No.- 4) Dhianpura (Kurali ) Punjab

Rupnagar
PUNJAB
140103
India 
Phone  9855808755  
Fax    
Email  Kamalrubal2010@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vijeta Attri 
Designation  student  
Affiliation  BFUHS 
Address  Saraswati Nursing Institute, (Gynae Department , Ground Floor, Room No.-8) Dhianpura (Kurali) Punjab

Rupnagar
PUNJAB
140103
India 
Phone  09736523876  
Fax    
Email  vijetaattri1998@gmail.com  
 
Source of Monetary or Material Support  
Civil hospital Phase-6 Mohali (SAS Nagar) Punjab 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [nil] 
 
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 
vijeta attri  Civil Hospital Phase-6 Mohali   Labour Room
Rupnagar
PUNJAB 		 9736523876

vijetaattri1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
civil hospital phase-6 mohali  Approved 
Saraswati Nursing Institute, Dhianpura Kurali  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Delivery in Upright Position  upright position Provided to the Pregnant Women Who are Considered Under experimental group. 
Comparator Agent  Standard Delivery  Standard care provided to the Pregnant Women Who are Considered Under control group. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Pregnant women in their 1st stage of labour.
Pregnant women who are in a natural process.
Pregnant women with single live fetus in cephalic presentation. 
 
ExclusionCriteria 
Details  Women with complicated pregnancy .
Women who are contraindicated for NVD.
Any abnormal condition of fetus. 
 
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 labour  Active Stage of Labour when Mother are at Full Term. 
 
Secondary Outcome  
Outcome  TimePoints 
General Health of Mother.
General Health of the Baby.
Perineal Laceration/Trauma. 		 Active Stage of Labour when Mother are at Full Term. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/04/2022 
Date of Study Completion (India) 31/05/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [vijetaattri1998@gmail.com].

  6. For how long will this data be available start date provided 01-01-2022 and end date provided 31-07-2022?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 A randomized controlled trial design and quantitative approach were used to assess the effects of the upright position on selected labour outcomes among 40 pregnant women at selected hospitals in Punjab by using a random sampling technique. The findings of the study revealed that the maintenance of an upright position during labour is effective and safe and it will reduce the duration of labour, perineal laceration/trauma, and general health of the mother and baby and reduces the chances of instrumental delivery. 
Close