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CTRI Number  CTRI/2022/03/041531 [Registered on: 31/03/2022] Trial Registered Prospectively
Last Modified On: 30/03/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Analytical 
Study Design  Other 
Public Title of Study   Labor Care Guide ratings by doctors 
Scientific Title of Study   WHO Modified Partogram versus Labour Care Guide (LCG) for Labour Monitoring 
Secondary IDs if Any  
Secondary ID  Registry 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  AG Radhika 
Address  Department of Obstetrics & Gynecology 7th Floor MCH GTB Hospital Dilshad Garden Delhi

North East
DELHI
110095
India 
Phone  01122692480  
Fax    
Email  raradhikaag@gmail.com  
 
Details Contact Person
Scientific Query
 
Name  AG Radhika 
Address  Department of Obstetrics & Gynecology 7th Floor MCH GTB Hospital Dilshad Garden Delhi

North East
DELHI
110095
India 
Phone  01122692480  
Fax    
Email  raradhikaag@gmail.com  
 
Details Contact Person
Public Query
 
Name  AG Radhika 
Address  Department of Obstetrics & Gynecology 7th Floor MCH GTB Hospital Dilshad Garden Delhi

North East
DELHI
110095
India 
Phone  01122692480  
Fax    
Email  raradhikaag@gmail.com  
 
Source of Monetary or Material Support
Modification(s)  
UCMS & GTB Hospital 
 
Primary Sponsor
Modification(s)  
Name  GTB Hospital 
Address  GTB Hospital 
Type of Sponsor  Government medical college 
 
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 
AG Radhika  GTB hospital  Labour Room, Department of Obstetrics & Gynecology 7th Floor MCH Block GTB Hospital Delhi
North East
 
09818065527

raradhikaag@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE – HUMAN RESEARCH (IEC-HR) UNIVERSITY COLLEGE OF MEDICAL SCIENCES UNIVERSITY OF DELHI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Resident doctors 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Labouring women planned for normal or induced vaginal delivery  
 
ExclusionCriteria 
Details  Women planned for elective cesarean section delivery  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
The proportion of completeness of WHO modified partogram with LCG
● Participants satisfaction with the WHO modified partogram versus the LCG on Likert scale and proportion of minimum score of 3 for each tool.
 
The proportion of completeness of WHO modified partogram with LCG at the end of 20 days
● Participants satisfaction with the WHO modified partogram versus the LCG on Likert scale and proportion of minimum score of 3 for each tool.
 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Maternal outcomes - mortality and morbidity namely PPH, Instrumental delivery, LSCS
● Fetal outcomes - stillbirth, Apgar score at 5 minutes, and NICU stay

 
3 months 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/04/2022 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not applicable 
Brief Summary
Modification(s)  

Introduction- Partogram is the most commonly used labour monitoring tool recommended by the World Health Organisation (WHO) for use in active labour [1]. While it is a basic tool [2,3], it has been noted that it is not being used or completed as intended, affecting labour management and outcomes [4,5]. Few studies reported that the partogram was difficult to use or time-consuming.(6)

Recently, WHO developed the "next-generation" partogram called the WHO Labour Care Guide (LCG). It is evidence based with updated definitions (7). The primary goal of our research will be to compare the current WHO Modified Partogram with LCG in terms of record completeness and resident doctor satisfaction.

 

Objective

Primary Objective:

 Compare LCG with WHO modified partogram for completion of records and satisfaction among the resident doctors with each tools

 Secondary objective:

   Compare maternal outcomes using LCG and WHO modified partogram for - mortality and morbidity namely, PPH, LSCS and Instrumental delivery.

   Compare fetal outcomes using LCG and WHO modified partogram for - stillbirth, five minute Apgar score, and NICU stay.

 

Justification : In a random survey conducted in September 2021 of 100 case records at our institution, it was found that of 78% of normal vaginal deliveries were monitored through Partogram, 22% were incomplete, and 13% were left blank(unpublished).

The present study is to identify if LCG is found better compared to modified Partogram as intended by WHO. Given the lack of senior and skilled medical personnel in low resource settings, appropriate labour monitoring is extremely important to ensure well being of the mother and baby. This study is expected to highlight the practical aspects of LCG use among medical personnel.

 

Methodology

This analytical observational study would be conducted in the Department Obstetrics and Gynecology, UCMS and GTB Hospital over 3 months. Consenting resident doctors posted in labour room will be requested to fill WHO modified partogram and LCG for 10 days each, followed by a questionnaire to compare both the tools to assess their satisfaction.

 

Sample size: With an assumption of improvement of 50% with LCG use, to estimate this difference at alpha-5% and power-80% a sample size of 35 subjects is required

 

Statistical Analysis: Both groups will be compared using the Student t-test and Chi-square test with SPSS software version 21.

 

Potential Risks - None

 

Potential benefits – Improvements in labour monitoring lead to better mother and fetal outcomes.

 

Outcome measures:

Comparison for

   The proportion of completeness of WHO modified partogram with LCG

   Participants’ satisfaction with the WHO modified partogram versus the LCG on Likert scale and proportion of minimum score of 3 for each tool.

  Maternal outcomes - mortality and morbidity namely PPH, Instrumental delivery, LSCS

  Fetal outcomes - stillbirth, Apgar score at 5 minutes, and NICU stay

 

National Significance

Maternal and neonatal morbidity and mortality following labour continues to be high in India. Given the continuing lack of senior and skilled medical personnel, appropriate labour monitoring is extremely important to ensure well being of the mother and baby. This study would provide a feedback from the user end and would facilitate for the next step for wider use.

 

References:

1.      World Health Organisation. WHO recommendations for augmentation of labour. Geneva: WHO; 2014.

2.      Mathews JE, Rajaratnam A, George A, Mathai M. Comparison of two World Health Organisation partographs. Int J Gynecol Obstet. 2007;96(2):147–50.

3.      Mathai M. The partograph for the prevention of obstructed labour. Clin Obstet Gynecol. 2009;52(2):256–69.

4.      Windrim R, Seaward G, Hodnett E, Akoury H, Kingdom J, Salenieks ME, et al. A randomized controlled trial of a bedside partogram in the active management of primiparous labour. J Obstet Gynaecol Can. 2007;29(1):27–34.

5.      Fistula Care and Maternal Health Task Force. Revitalizing The Partograph: Does The Evidence Support A Global Call To Action?—Report of an Expert Meeting, New York, November 15–16, 2011. EngenderHealth/Fistula Care. 2012. Available from: http://www.fistulacare.org/pages/pdf/program-reports/EngenderHealth-Fistula-Care-Partograph-Meeting-Report-9-April-12.pdf.

6.      Completion of the modified World Health Organization (WHO) partograph during labour in public health institutions of Addis Ababa, Ethiopia.Yisma E, Dessalegn B, Astatkie A, Fesseha N, Reprod Health. 2013 Apr 18; 10():23.

7.      WHO recommenations: intrapartum care for a positive childbirth experience. Geneva: World Health Organization;2018.

 

 

 

 

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