Condition category
Pregnancy and Childbirth
Date applied
24/01/2020
Date assigned
16/04/2020
Last edited
28/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Suspended

Plain English Summary

Background and study aims
The study is part of a large programme of work to prevent preterm birth and stillbirth, DIPLOMATIC.

This is an implementation study of a training package for midwives to accurately assess gestational age from ultrasound scan 'in the first 24+6 weeks of pregnancy. Training in Ultrasound to Determine gestational Age (TUDA) forms the initial part of Work Package 5 within the DIPLOMATIC Programme, a National Institute for Health Research funded global health research programme, which aims to identify optimal interventions for the prevention of preterm birth and stillbirth in Malawi and Zambia.

Prevention and treatment of preterm birth requires an accurate assessment of gestational age during pregnancy. This is best achieved through ultrasound scanning (USS) measurements prior to 24 weeks gestation. The World Health Organisation (WHO) endorses the use of one ultrasound scan before 24 weeks gestation for all pregnant women. Such a goal is currently unattainable in many Low and Middle-Income Countries (LMIC) due to lack of availability of trained staff and ultrasound machines.

This pilot study aims to provide an ultrasound training program to enable staff to reach competency in determining the gestational age, the number of fetuses and fetal viability in early pregnancy. The establishment of accurate pregnancy dating by ultrasound scan in the selected settings is in keeping with current WHO recommendations (WHO 2016). We anticipate this information will inform the roll-out of an effective training package in Malawi and potentially also in Zambia

Who can participate?
1. The pilot will involve 8- 12 individual staff trainees per two sites and 3 trainers. Midwives and Clinical officers will be identified through the District nursing officers and District Health officers and those self-motivated and willing to gain ultrasound skills will be asked to write personal statements that would be scrutinized by the study investigators. Eligible participants will be notified then invited for training.
2. Around 120 (per training site) antenatal women will consent to be scanned by more than one trainee.

What does the study involve?
For trainees, there will be one week of training, using the program designed for the TUDA study, followed by a four-week supervised evaluation of training. During the evaluation, midwives across the two participating health centres will be supervised closely to ascertain how much ongoing support is required to incorporate the scans into their routine pregnancy care. Quesionnaires will be used to explore the midwives’ views and experience of the training package.

For patients, trainee midwives will use an ultrasound scan to assess how far along in their pregnancy they are.

What are the possible benefits and risks of participating?
No risks are anticipated to either trainees or women participating in this study.

Trainees will learn basic ultrasound skills and in time may be asked to help teach this to other people.

It will be possible to determine accurately how far along in their pregnancy women who participate currently are and this can be helpful if problems develop and the baby needs to be delivered early. Women will also be compensated for their time and travel.

Where is the study run from?
The training of staff and recruitment of women will take place in Malawi Liverpool Wellcome Trust (Malawi) and Mzuzu Central Hospital (Malawi)

When is the study starting and how long is it expected to run for?
April 2018 to March 2021

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr. Alex Viner, A.Viner@ed.ac.uk (UK)
Dr. Luis Gadama, lgadama@medcol.mw (Malawi)

Trial website

https://www.ed.ac.uk/centre-reproductive-health/diplomatic/diplomatic-study

Contact information

Type

Public

Primary contact

Mrs Sonia Whyte

ORCID ID

http://orcid.org/0000-0003-0878-4244

Contact details

Room W1.14 QMRI
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
+44 01312422693
sonia.whyte@ed.ac.uk

Type

Scientific

Additional contact

Dr Luis Gadama

ORCID ID

http://orcid.org/0000-0002-7164-6197

Contact details

University of Malawi College of Medicine
Blantyre
Southern Region
Malawi
+265 99 104 2320
lgadama@medcol.mw

Type

Scientific

Additional contact

Dr Alexandra Viner

ORCID ID

http://orcid.org/0000-0002-7674-6402

Contact details

Room W1.01 QMRI
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
+44 01312422693
A.Viner@ed.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Version 2

Study information

Scientific title

The evaluation and implementation of a training package teaching ultrasound-naive midwives to become competent in establishing number of fetuses, fetal viability and gestational age prior to 24+6 weeks gestation

Acronym

TUDA

Study hypothesis

To evaluate the optimum methodology and minimum duration of training for ultrasound naive midwives to develop competency in performing scans to establish number of fetuses, fetal viability and determine gestational age under 24+6 weeks gestation

Ethics approval

Approved 22/11/2019, University of Malawi College of Medicine Research and Ethics Committee (COMREC, College of Medicine, P Bag 360, Blantyre), ref: P.08/19/2768

Study design

This is a mixed-methods pilot study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

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

Condition

Pregnancy

Intervention

8 to 12 health care workers from each of the participating centres will be trained over a period of one week using a bespoke training package designed to teach ultrasound niece midwives to perform ultrasound scans in the first 24 weeks of pregnancy to establish number of fetuses, fetal viability and determine gestational age using either crown-rump length or femur length measurements.

This will include classroom and clinical training. They will go for 4 weeks of mentorship at their respective facilities and their ultrasound competencies will be assessed. Ongoing competency will be based on the review of images and measurements sent from the midwives during the subsequent 4 week supervisory period. Continued support is also offered for a period of up to 6 weeks or longer if required. A small number will be invited to complete an interview about their experience of the training.

240 pregnant women will be recruited and will receive up to 4 fetal ultrasound scans in one day from trainees to determine accurately how far in pregnancy they are.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Gestation using measurement of either crown-rump length or femur length as compared with the trainers' results, through observation of the trainees' global clinical skills and through ongoing assessment of the trainees' images during the subsequent supervisory phase

Secondary outcome measures

1. To identify the experiential learning requirements which must be met after formal training to facilitate independent practice over a four week period. Trainee competency will be based on the achievement of 5 consecutive measurements that are within 10% of those obtained by the trainers and a global assessment from the trainers as to whether they deem the candidate ready based on observation of their performance. If they are not competent at the end of the week competency will be assessed based on review of their submitted images during the supervisory phase.
2. To evaluate whether femur length measurements alone are adequate to assess fetal gestation in the study population using ultrasound scan assessed by comparing the estimated due date determined by the trainers' 3 femur length measurements to the estimated due date given by the trainers' composite measurements of head circumference, abdominal circumference and femur length
3. To explore the midwives’ views and experience of the training package using questionnaires and interviews to discuss their confidence in performing scans independently at the end of the 4 weeks mentorship.

Overall trial start date

01/04/2018

Overall trial end date

31/03/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients who are:
a. Pregnant
b. Estimated age ≥ 18 years
c. Signed (and witnessed, if applicable) informed consent given
2. Trainees who are:
a. Self-motivated midwives registered by the nurses and midwives council of Malawi and Clinical officers registered by the Medical Council of Malawi
b. Informed consent given

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

Patients 240, Trainees 25

Participant exclusion criteria

≥ 26 weeks’ gestation based on clinical assessment prior to recruitment (note, where the trainer’s femur length measurement subsequently suggests that the pregnant woman is more than 24+6 weeks’ gestation the data will be discarded)

Recruitment start date

20/01/2020

Recruitment end date

01/04/2020

Locations

Countries of recruitment

Malawi

Trial participating centre

Malawi Liverpool Wellcome Trust
Queen Elizabeth Central Hospital College of Medicine PO Box 30096 Chichiri
Blantyre
n/a
Malawi

Trial participating centre

Mzuzu Central Hospital
Private Bag 209
Mzuzu
n/a
Malawi

Sponsor information

Organisation

University of Edinburgh

Sponsor details

ACCORD QMRI
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
0131 242 3330
researchgovernance@ed.ac.uk

Sponsor type

University/education

Website

http://www.accord.ed.ac.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Research findings will be presented to the Ministry of Health Safe Motherhood technical working Group, the Association of Obstetricians and Gynaecologists of Malawi, regulatory bodies in Malawi, the NIHR global health research group on preterm birth and stillbirth at the University of Edinburgh (the DIPLOMATIC collaboration) and conferences on Maternal and Child Health.

Research findings will also be published in peer-reviewed journals and a copy will be sent to the College of Medicine Research Ethics Committee (COMREC).

IPD sharing statement:
The data-sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

01/04/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

28/05/2020: Due to current public health guidance, recruitment for this study has been paused. 27/01/2020: Trial’s existence confirmed by the University of Malawi College of Medicine Research and Ethics Committee.