| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z139||Encounter for screening, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
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. |