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CTRI Number  CTRI/2021/10/037302 [Registered on: 13/10/2021] Trial Registered Prospectively
Last Modified On: 26/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study
Modification(s)  
To study the effect on cesarean section rate by monitoring the labor progression with the use of 2 different partographs  
Scientific Title of Study   To compare the rate of cesarean section with the use of new WHO partograph and the old WHO partograph - A randomized controlled trial 
Secondary IDs if Any
Modification(s)  
Secondary ID  Registry 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Sonal Agarwal 
Address  AIIMS, Jodhpur, Basni Industrial Area, MIA 2nd Phase, Basni, Jodhpur, Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone  9511563850  
Fax    
Email  drsonalagarwal501@gmail.com  
 
Details Contact Person
Scientific Query

Modification(s)  
Name  Dr Pratibha Singh 
Address  AIIMS, Jodhpur, Basni Industrial Area, MIA 2nd Phase, Basni, Jodhpur, Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone  8003996941  
Fax    
Email  drpratibha69@hotmail.com  
 
Details Contact Person
Public Query

Modification(s)  
Name  Dr Pratibha Singh 
Address  AIIMS, Jodhpur, Basni Industrial Area, MIA 2nd Phase, Basni, Jodhpur, Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone  8003996941  
Fax    
Email  drpratibha69@hotmail.com  
 
Source of Monetary or Material Support  
AIIMS Jodhpur 
 
Primary Sponsor  
Name  AIIMS Jodhpur 
Address  AIIMS Jodhpur 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr Sonal Agarwal  All India Institute Of Medical Sciences, Jodhpur  Department of Obstetrics and Gynaecology, D&T block, second floor, Labor Room
Jodhpur
 
9511563850

drsonalagarwal501@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe, AIIMS Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Encounter for full-term uncomplicated delivery 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  Old WHO Partograph  labour progression in the control group will be monitored via the old WHO Partograph, from onset of active phase of first stage of labour 
Intervention  WHO Labour Care Guide (new WHO Partograph)  labour progression in the intervention group will be monitored via the WHO Labour Care Guide which is the new WHO Partograph, from onset of active phase of first stage of labour till second stage of labour 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  All pregnant women (both primigravida and multigravida) with singleton pregnancy at >36 weeks gestation admitted for vaginal delivery. 
 
ExclusionCriteria 
Details  1. Women admitted for elective LSCS.
2. Women with multifetal pregnancy.
3. Women with malpresentation.
4. Women with h/o uterine surgery eg: cesarean section, myomectomy etc.
5. Women with contracted pelvis or cephalopelvic disproportion.
6. Patients not giving consent
 
 
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 Compare the rate of cesarean section with the use of New WHO Partograph And The Old WHO Partograph in labouring antenatal females.  from onset of active phase of first stage of labour till second stage of labour 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the duration of labour with the use of new WHO partograph and the old WHO partograph.
2. To assess ease of use, acceptability and feasibility of the new WHO partograph among health care practitioners (Doctors and Nurses) in the labour room.
3. To compare neonatal outcome with the use of the new WHO partograph and the old WHO partograph.
4. To assess patient satisfaction.
 
during labour and immediate postnatal period 
 
Target Sample Size   Total Sample Size="570"
Sample Size from India="570" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  
18/10/2021 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
NIL 
Brief Summary  

In November 2020, the WHO introduced the new WHO partograph based on WHO’s latest intrapartum care recommendations which include updated definitions for first and second stage of labour, based on evidence from systematic review.

 

To the best of our knowledge this is the first study to compare the new WHO partograph and the old WHO partograph. The cesarean delivery rates in India over the past years show a rising trend, exceeding the WHO recommended rate of 10-15%.  We  hereby  aim  to  compare  the  new  WHO  partograph  and  the  old  WHO  partograph to reduce cesarean section rate.

 

Our primary objective is to compare the rate of cesarean section with the use of the new WHO partograph and the old WHO partograph. Our secondary objectives are to:

(a)   (a)   compare duration of labour,

(b)   to compare neonatal outcome,

(c)   to assess ease of use, acceptability and feasibility of the new WHO partograph, and

(d)   to assess patient satisfaction.

 

All the women at period of gestation >36 weeks, admitted for vaginal delivery and fulfilling inclusion criteria will be recruited for the study. Subjects will be allocated into intervention and control group on the basis of randomization. Simple randomization with 1:1 allocation will be followed. Computer generated Random sequences will be generated by online software (https://www.sealedenvelope.com/simple-randomiser/v1/lists) by an individual not involved in enrollment, treatment and follow up of study. Random sequences will be used to make  identical, opaque, sealed envelopes with Unique random  number written over the envelope. These envelopes will be made by a person not involved  in enrollment, treatment and follow up of study. These envelopes will be kept in the Department office for safe-keeping.

Every time, the eligible patient gives consent for the study, one Random closed envelop will be picked by person not involved in the study. It will be handed over to the investigator. According to the code written in the letter, Patient will be allocated in group A (intervention group) or group B (control group).

 Progression of labour will be monitored in intervention (group A) and control group (group B) with the help of the new and the old WHO partograph respectively. If the outcomes with the use of the new WHO partograph are favourable as compared to the old WHO partograph, it will be a valuable tool for achieving reduction in cesarean section rate.

 

 


 

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