Condition category
Pregnancy and Childbirth
Date applied
02/12/2017
Date assigned
05/12/2017
Last edited
05/12/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
An estimated 289,000 maternal deaths, 2.6 million stillbirths and 2.4 million newborn deaths occur globally each year, with most occurring around the time of childbirth. Kenya continues to have a high level of maternal and newborn death; maternal mortality was estimated at 510 per 100,000 live births in 2015 and child mortality to be 52 per 1,000 live births. This means that an estimated 6,000 to 8,000 pregnant women die in Kenya every year. The medical and surgical interventions to prevent these deaths are known, and most maternal and newborn deaths are in principle preventable. Providing emergency obstetric and newborn care (EmONC) by skilled birth attendants is known to reduce maternal and newborn mortality. The Kenyan government has included emergency obstetric and newborn care as a priority in their National Health Strategy. In 2012, the Ministry of Health in Kenya adapted the Liverpool School of Tropical Medicine (LSTM) EmONC training package and produced national curriculum/guidelines in 2014 for implementation nationally. However, the focus has been on in-service EmONC capacity building. To improve the effectiveness of periodic in-service EmONC training programmes, EmONC must be adequately covered within pre-service midwifery and medical curriculum and adequately taught in training institutions. LSTM has previously supported several midwifery training institutions in Kenya to improve the content and quality of EmONC training within their curriculum. However, the effect of these interventions has not been determined. Although there have been two studies evaluating the effectiveness of EmONC training for pre-service students but generalising the results is limited by the type of participants included (medical students and interns) and weak study designs. The aim of this study is to examine the effectiveness of EmONC training and to see if it improves the skills and knowledge of participants.

Who can participate?
Final year midwifery students in Kenya medical training institutions.

What does the study involve?
Participating medical training institutions are randomly allocated to one of three groups. Those in the first group receive no EmONC programmes. Those in the second group receive it partially. Those in the last group receive the full EmONC programme. Participants are followed up with questionnaires and skill assessments to measure their knowledge, skills and confidence. The knowledge and skills of 60 students in each of the KMTCs in each group will be assessed and compared.

What are the possible benefits and risks of participating?
There are no risks or immediate benefits for participation in the study. The lectures in the participating institutions will not be involved in student assessments and the investigators will not disclose individual participant assessment results to the lecturers or administrative authorities of these institutions. The results from the study will improve the understanding of the effect of EmONC training interventions on the knowledge and skills of final year midwifery students compared with the standard curriculum, potentially resulting in improvements to the standard curriculum.

Where is the study run from?
1. Centre for Maternal and Newborn Health Liverpool School of Tropical Medicine (UK)
2. Liverpool School of Tropical Medicine Kenya (Kenya)

When is the study starting and how long is it expected to run for?
July 2017 to June 2018

Who is funding the study?
United Kingdom Department for International Development (UK)

Who is the main contact?
Dr Charles Ameh
Charles.Ameh@lstmed.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Charles Ameh

ORCID ID

http://orcid.org/0000-0002-2341-7605

Contact details

Centre for Maternal and Newborn Health
Liverpool School of Tropical Medicine
Liverpool
L147AN
United Kingdom
+44 151 705 3706
Charles.Ameh@lstmed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LSTM 17-059

Study information

Scientific title

A cluster randomised controlled trial of an intervention to improve the emergency obstetric care knowledge and skills of midwifery students prior to graduation in Kenya

Acronym

Kenya PETI study (Kenya Pre-service Emergency obstetric care Training Interventions Study)

Study hypothesis

Emergency obstetric care training interventions results in better knowledge and skills amongst final year midwifery students compared to their standard training curriculum. The specific research questions are:
1. What is the effect of EmONC capacity building interventions on knowledge and skills of pre-service midwifery students?
2. What is the effect of EmONC capacity building interventions on self-reported confidence to provide EmONC?

Ethics approval

1. The Liverpool School of Tropical Medicine Research and Ethics Committee, 01/12/2017, ref: No.: 17-059RS
2. Kenyatta National Hospital Research and Ethics Committee Nairobi Kenya

Study design

Cluster randomised control trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Emergency obstetric care capacity building/training interventions

Intervention

The four emergency obstetric and newborn care (EmONC) capacity building interventions are:
a. EmONC training for midwifery teachers: Midwifery teachers/lecturers are trained in the LSTM 5-day EmONC course.
b. Training of EmONC trainers for midwifery teachers: Midwifery teachers/lecturers are trained to use evidence based EmONC training methods and content. Training in EmONC (a-above) is a pre-requisite to this training.
c. Supply of EmONC training equipment for skills laboratory: Supply of EmONC training equipment and technical support to set-up and use the skills labs.
d. Supportive supervision/mentorship: 3-monthly visits to supported KMTCs to facilitate the use of evidence based EmONC training methods and content.

Intervention and control groups:
There are two intervention (partial or full EmONC capacity building interventions) and one control group (no EmONC capacity building intervention):
1. No EmONC intervention: Training colleges that have received NO previous EmONC capacity building interventions between 2014 and 2017.
2. Partial EmONC intervention: Training colleges that have SOME EmONC capacity building training interventions between 2014 and 2017.
3. Full EmONC intervention: Training colleges that have received ALL the EmONC capacity building interventions between 2014 and 2017.

Based on the Kenya National EmONC guidelines, intervention ‘a’ is a pre-requisite for b and d. Intervention ‘a’ is mandatory for Colleges in the partial intervention group.

The sampling frame includes all eight regions in the country to ensure a large enough sample is obtained. Including training colleges from different areas across the country also help ensure the generalisability of the findings.
To determine the sample frame in each group of the study from which 4 Kenya Medical Training College (KMTCs) are drawn, the research team based in Nairobi work with the headquarters of KMTC and principals of all colleges in the country to map out all Colleges in each group based on the predefined group characteristic (see EmOC training interventions above). Information that is collected are:
1. Availability of a 2018 midwifery final year cohort. If available number of students
2. External support for EmOC training since January 1st 2014 and defining the type of support (training of teaching and clinical supervision staff, supply of EmOC mannequins for training, supportive supervision after EmOC training of clinical staff)

After excluding KMTCs without final midwifery cohort, the Colleges are grouped into three, and given unique numbers by the PI. Four colleges are then be randomly selected in each group. The PI is responsible for randomisation and concealment of the study arms. The training colleges in each of the groups are randomly allocated, using computer generated random numbers until the group size is achieved. The group characteristic will only be revealed to the rest of the research team after analysis. These groups are based on predefined study characteristics (see intervention and control groups section above).

The data collectors are blinded from the trial characteristic of each institution. Each data collection team collects data from 4 institutions with different trial characteristic. All data collectors are from a different county to where the institution is located and midwifery educators/teachers in that institution are not involved in data collection. Finally, the statistician performing the analysis are blinded from the trial characteristic of each study arm. Prior to interpreting the data, the PI reveal the concealment. The PI is not be involved in data collection but train the data collectors.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Student knowledge and skills are measured for all groups using the multiple-choice questions and skill assessment score within 2 weeks across all assessment sites.

Secondary outcome measures

Student self-reported confidence in performing EmONC skills is measured using Casey-Fink Readiness for Practice Survey and the Likert scale questionnaire are administered after the knowledge and skills assessments for all groups during the data collection period of 2 weeks.

Overall trial start date

10/07/2017

Overall trial end date

01/06/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Individual participant:
Final year midwifery students in Kenya medical training institutions.

Participating institutions:
All Kenya medical training colleges with a final year cohort in 2018 including institutions that have received external interventions to improve emergency obstetric training.

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

240

Participant exclusion criteria

Kenya medical training colleges without final year midwifery students in 2018.

Recruitment start date

01/03/2018

Recruitment end date

30/04/2018

Locations

Countries of recruitment

Kenya

Trial participating centre

Centre for Maternal and Newborn Health
Liverpool School of Tropical Medicine
Liverpool
L3 5QA
United Kingdom

Trial participating centre

Liverpool School of Tropical Medicine Kenya
Nairobi
P.O. Box 24672-00100
Kenya

Sponsor information

Organisation

Liverpool School of Tropical Medicine

Sponsor details

Pembroke Place
Liverpool
L147AN
United Kingdom
+44 151 705 3796
lstmrec@lstmed.ac.uk

Sponsor type

University/education

Website

http://www.lstmed.ac.uk

Funders

Funder type

Government

Funder name

United Kingdom Department for International Development

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Dissemination:
A report will be prepared for each participating KMTC containing the overall findings, and each KMTCs anonymised school-level knowledge and skill assessment results.

A full report of the study will be provided to the trial funder, the Kenya Ministry of Health and the Kenya Pre-Service National Taskforce Committee. If the findings show the intervention to be effective, further qualitative data will be collected to explore best practices. The information from both qualitative and quantitative aspects will be written up as a guidance document for KMTCs. This will be shared with the Kenya Ministry of Health and the Pre-Service National Taskforce Committee.

Peer reviewed publications:
Papers reporting on the main outcomes will be published in peer reviewed journals.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Charles Ameh, Principal Investigator Charles.Ameh@lstmed.ac.uk.

Intention to publish date

30/10/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes