FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/08/020600 [Registered on: 07/08/2019] Trial Registered Prospectively
Last Modified On: 17/12/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Mixed methods usability evaluation 
Study Design  Other 
Public Title of Study   Labour Care Guide Evaluation 
Scientific Title of Study   Evaluating the WHO Labour Care Guide in clinical settings 
Trial Acronym  LCG 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shivaprasad S Goudar 
Designation  Professor of Physiology 
Affiliation  KLE Academy of Higher Education and Researchs J N Medical College 
Address  Professor Department of Physiology, KLE Universitys J N Medical College Nehru Nagar Belgaum Principal Investigator Womens and Childrens Health Research Unit Wing Belgaum

Belgaum
KARNATAKA
590010
India 
Phone  9448126371  
Fax  8312472891  
Email  sgoudar@jnmc.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shivaprasad S Goudar 
Designation  Professor of Physiology 
Affiliation  KLE Academy of Higher Education and Researchs J N Medical College 
Address  Professor Department of Physiology, KLE Universitys J N Medical College Nehru Nagar Belgaum Principal Investigator Womens and Childrens Health Research Unit Wing Belgaum


KARNATAKA
590010
India 
Phone  9448126371  
Fax  8312472891  
Email  sgoudar@jnmc.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Shivaprasad S Goudar 
Designation  Professor of Physiology 
Affiliation  KLE Academy of Higher Education and Researchs J N Medical College 
Address  Professor Department of Physiology, KLE Universitys J N Medical College Nehru Nagar Belgaum Principal Investigator Womens and Childrens Health Research Unit Wing Belgaum


KARNATAKA
590010
India 
Phone  9448126371  
Fax  8312472891  
Email  sgoudar@jnmc.edu  
 
Source of Monetary or Material Support  
World Health Organization 
 
Primary Sponsor  
Name  World Health Organization 
Address  Department of Reproductive Health and Research, 20 Avenue Appia, CH 1211, Geneva 27, Switzerland 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Australia
India
Kenya
Malawi
United Kingdom  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sujata Misra  Fakir Mohan Medical College Hospital  Department: Obstetrics and Gynecology, Januganj Rd, Kalidaspur, Balia 756019
Baleshwar
ORISSA 
9437094466

drsujatamisra@gmail.com 
Dr Shivaprasad S Goudar  KLES Dr Prabhakar Kore Hospital and Medical Research Centre Belgaum  Department: Womens and Childrens Health Research Unit Wing Institution: KLE Academy of Higher Education and Researchs J N Medical College Nehru Nagar Belgaum
Belgaum
KARNATAKA 
9448126371
8312472891
sgoudar@jnmc.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, KLE Academy of Higher Education and Research, Belagavi  Approved 
Institutional Ethics Committee,Fakir Mohan Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z139||Encounter for screening, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Eligible healthcare providers are:
a.Employed by the participating facility
b.Staff members (trainee obstetricians or registrars are eligible but medical, midwifery or nursing students are not eligible)
c.Currently providing intrapartum care in participating facilities; and
d.Experienced in the use of a partograph (as per facility protocols).
2. Pregnant women with following criteria:
a. Women attending participating facilities in early labour (i.e. less than 6cm cervical dilation), following spontaneous onset of labour, with a live, singleton, cephalic pregnancy
b. Aged 18 to 34
c. Term pregnancies (37-41 weeks 6 days of gestation) based on best obstetric estimate of gestational age
d. No uterine scar
e. Are at low-risk of adverse childbirth outcomes at arrival to the facility, according to local definitions (i.e. does not have any complications of pregnancy, such as hypertension, pre-eclampsia, antepartum haemorrhage, fetal growth restriction or other fetal complications identified on arrival at facility)
f. Women in whom a vaginal birth is anticipated
 
 
ExclusionCriteria 
Details  1. High risk pregnant women as per facility protocols 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess usability of the WHO Labour Care Guide with healthcare providers;
To explore healthcare provider’s views on the feasibility and acceptability of the WHO Labour Care Guide;
 
The study timeline is 10 months including data collection and analysis 
 
Secondary Outcome  
Outcome  TimePoints 
To explore barriers and facilitators to implementing the WHO Labour Care Guide in routine clinical practice; and
To determine what (if any) improvements should be made to the WHO Labour Care Guide.
 
The study timeline is 10 months including data collection and analysis 
 
Target Sample Size   Total Sample Size="1200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "1226"
Final Enrollment numbers achieved (India)="200" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/09/2019 
Date of Study Completion (India) 04/12/2019 
Date of First Enrollment (Global)  01/09/2019 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Vogel JP, Comrie-Thomson L, Pingray V, Gadama L, Galadanci H, Goudar S, Laisser R, Lavender T, Lissauer D, Misra S, Pujar Y, Qureshi ZP, Amole T, Berrueta M, Dankishiya F, Gwako G, Homer CSE, Jobanputra J, Meja S, Nigri C, Mohaptra V, Osoti A, Roberti J, Solomon D, Suleiman M, Robbers G, Sutherland S, Vernekar S, Althabe F, Bonet M, Oladapo OT. Usability, acceptability, and feasibility of the World Health Organization Labour Care Guide: A mixed-methods, multicountry evaluation. Birth. 2020 Nov 22. doi: 10.1111/birt.12511. Epub ahead of print. PMID: 33225484. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Project background and rationale: The partograph is an important clinical tool for monitoring a woman’s progress during labour and childbirth that is in routine use worldwide. In 2018, WHO released updated intrapartum care recommendations that included definitions and durations of the first and second stages of labour.   A revised version of the WHO partograph – the “WHO Labour Care Guide” (LCG) – has been developed to make it easier for healthcare providers to implement these evidence-based recommendations in routine clinical practice.

The LCG has been developed using human-centred design principles, including expert consultations, international surveys and focus group discussions.  However, it is critical to ensure that the LCG is able to meet care providers’ needs in real-world clinical settings. Mixed-methods usability evaluation can provide important data on how the current LCG design can be optimised.

 Aims and Objectives: The aim of this project is for healthcare providers to pilot-test the LCG in clinical settings, in order to evaluate its usability, feasibility and acceptability, as well as barriers and facilitators to its use. 

The objectives are:

1.      To assess usability of the WHO Labour Care Guide with healthcare providers;

2.      To explore healthcare provider’s views on the feasibility and acceptability of the WHO Labour Care Guide;

3.      To explore barriers and facilitators to implementing the WHO Labour Care Guide in routine clinical practice; and

4.      To determine what (if any) improvements should be made to the WHO Labour Care Guide. 

Methods: This is a three-step evaluation project that will be conducted in 12 health facilities across 6 countries (two facilities per country). Participating facilities are those providing at least basic emergency obstetric and neonatal care, with more than 1,000 births per year. In each facility, 10 healthcare providers (experienced in partograph use) will be purposively sampled (to ensure diversity of cadres and years of experience in labour ward) and invited to participate. 

In step one, consenting providers will undergo a standardized training in correct use of the LCG, which will then be used in monitoring and managing labour and childbirth of a sample of low-risk women (each i.e. 100 women per facility).  In step 2, eligible women will be identified through screening and consent sought prior to participation. Eligible women are those in early spontaneous labour, with a singleton, cephalic, term, low-risk pregnancy in whom a vaginal birth is anticipated. Providers will complete the LCG as part of routine childbirth care. Data (non-identifiable) on women’s characteristics and birth outcomes will be collected, along with completed LCG’s. Providers will complete a short postpartum questionnaire soon after each birth (i.e. within 6 hours) on their experience with the LCG. In step 3 (once the facility target of 100 women has been reached), providers will participate in focus group discussions (FGDs, 1 per facility) to explore their views on the feasibility and acceptability of the LCG, any recommendations for change, as well as potential barriers and facilitators in implementing the LCG in their setting. FGDs will be audio-recorded and transcribed by a project staff member at each site. Providers will also complete an endline questionnaire to assess usability and provider satisfaction with the LCG. 

Quantitative data (accuracy and completeness of LCGs, provider usability and satisfaction scores and birth outcomes) will be reported descriptively (overall and per site). Qualitative data on feasibility, acceptability, barriers and facilitators will be analysed using framework analysis. 

Outputs: This project will provide data from a range of countries and perspectives on how the current iteration of the LCG can be improved. It will provide important data on the feasibility and acceptability of the LCG in these settings, as well as identifying potential barriers and facilitators to its integration into routine care.

 
Close