Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202010788566263 Date of Approval: 19/10/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title DIPLOMATIC
Official scientific title Evaluating the implementation of routine antenatal US for estimating date of delivery in Malawi and Zambia; an interrupted time series trial
Brief summary describing the background and objectives of the trial A major barrier to effective prevention and management of preterm birth in Malawi and Zambia is the lack of an accurate, consistently applied, estimated date of delivery (EDD) for each pregnant woman. This is best achieved through ultrasound Scanning (USS) measurements prior to 24 weeks gestation. Indeed, the World Health Organisation (WHO) endorses the use of one ultrasound scan before 24 weeks gestation for all pregnant women. Such a goal is unattainable in many Low and Middle Income Countries (LMIC) due to lack of availability of trained staff and ultrasound machines. In participating health facilities in Malawi and Zambia we aim to provide an accurate, consistently applied estimated date of delivery (EDD) for each pregnant woman, which is maintained throughout the duration of the pregnancy and used to determine gestational age. We will assess the acceptability and feasibility of implementation of ultrasound scanning, and find ways to ensure gestational age are determined by a fixed EDD as part of routine early antenatal care. We will evaluate the process outcomes associated with this, including assessing adoption, fidelity and penetration, whilst reviewing the number of women who had an EDD established in early pregnancy and of those the number for whom this was not changed. We will also evaluate clinical outcomes of relevance including the rates of referral for pre-term, post-dates and the number of pregnancies where multiple births are diagnosed at the time of delivery. We will also evaluate stakeholders’ perceptions of the interventions and their implementation and review overall client satisfaction.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) DIPLOMATIC
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/10/2020
Actual trial start date 21/10/2020
Anticipated date of last follow up 30/06/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 12000
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL https://www.ed.ac.uk/centre-reproductive-health/diplomatic/diplomatic-study
Secondary Ids Issuing authority/Trial register
AC19091 University of Edinburgh
P 08 19 2768 College of Medicine Research Ethics Committee Malawi
0017620 Lusaka Apex Medical University Research Ethics Committee
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ultrasound and Estimated Gestational Age Training 9 Months This is a prospective study that will implement a package of care to improve estimation of gestational age at health facilities and district hospitals in Malawi and Zambia. Quantitative data will be collected pre-intervention for a 3-month period, the intervention will be introduced at each site and implemented for six months, there will be a brief “wash-out’ period of one month and then a further three months of data collection. 6000
Control Group Pre Implementation 9 Months Women will receive usual care 6000 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Service providers (including obstetricians, clinicians, midwives and maternity based support staff) in a participating facility. All women attending for antenatal care at any of the participating sites will automatically be enrolled into the study and excluded only if they do not wish to participate. Women who do not wish to participate. In this situation they would proceed with routine antenatal care without having an ultrasound scan. They may however, still be unavoidably exposed to educational materials. Their pregnancy data would not be collected. Service providers who do not wish to participate. In this situation we would encourage them to engage for a short interview to explain the reasons for their reluctance, allowing us to better understand and address barriers to implementation. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 55 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/11/2019 College of Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Private Bag 360 Chichiri, Blantyre 3111 Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 31/07/2020 Lusaka Apex Medical University Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Mutandwa Campus PO BOX 31909 Lusaka 10101 Zambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To provide an accurate EDD for each pregnant woman, which is used to assign gestational age consistently throughout pregnancy and at delivery and to evaluate stakeholders’ perceptions of the interventions and their implementation and to review overall client satisfaction. Primary process outcome measures EDD assigned by USS prior to 24+6 Gestational age assessment made on criteria other than EDD established by USS prior to 24+6 weeks at any time during pregnancy Recruitment and last patient last visit.
Secondary Outcome Secondary process outcome measures • EDD assigned by USS is used to document gestational age at delivery • Multiple pregnancy diagnosed for the first time at delivery • Mean gestational age at first presentation to antenatal services • Rates of referral for suspected preterm delivery • Rates of referral for management of post-dates Safety outcomes • Stillbirth rates • Rates of pre-term delivery • Rates of LBW delivery • Rates of referral for obstetric emergency • Maternal mortality rates • Perinatal mortality rates • Coverage of routine ANC care delivery at ANC1 • Coverage of routine ANC care delivery by time of delivery Features and frequency of USS referred by midwives • Nature of queries • Frequency of queries over time • Outcome of expert assessment Baseline data will be collected on: • Patient characteristics • Facility characteristics Quality and validity of USS assessments • Correlation of subset of quality metrics related to US delivery Following the last patient last visit
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Levy Mwanawasa University Teaching Hospital Levy Mwanawasa University Teaching Hospital Lusaka 10101 Zambia
Mother and New Born Hospital University Teaching Hospital Nationalist Road Lusaka 10101 Zambia
Matero Chitimukulu Road, P.O. Box 50827, Lusaka Matero 10101 Zambia
Chipata C/o District Health Office, P. Box 50827 Lusaka 10101 Zambia
Chilenje C/o District Health Office, P. Box 50827 Lusaka 10101 Zambia
Chawama C/o District Health Office, P. Box 50827 Lusaka 10101 Zambia
Kanyama C/o District Health Office, P. Box 50827 Lusaka 10101 Zambia
George Clinic C/o District Health Office, P. Box 50827 Lusaka 10101 Zambia
Chongwe District Hospital C/o District Health Office, P. Box 50827 Lusaka 10101 Zambia
Liteta District Hospital P. Box 3142 Chibombo 10101 Zambia
Mumbwa General Hospital PO Box 830008 Mumbwa 10101 Zambia
Mumbwa Urban Clinics PO Box 831008 Mumbwa 10101 Zambia
Zingwangwa Health Centre Zingwangwa Township 200 meters from the road on the left first Junction P/bag 66 Blantyre South East Zone 0 Malawi
Mpemba Health Centre Jiya Village Opposite Staff Development Institute P/Bag 66 Blantyre SouthEast 0 Malawi
South Lunzu Area 2 Opposite old court , near Namilango Primary School P/Bag 66 Blantyre South East Zone 0 Malawi
Area 25 Health Centre Lilongwe AREA 25 Health centre, Lilongwe 207225 Malawi
Chilumba Rural Hospital none Chilumba 102106 Malawi
Karonga District Hospital M1 Karonga 102100 Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
NIHR Global Health Alpha house Enterprise Road Southampton United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Edinburgh ACCORD office 47 Little France Crescent Edinburgh United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Dr. Bridget Freyne Queen Elizabeth Central Hospital P.O. Box 30096 Blantyre Malawi
Dr Gladys Gadama College of Medicine Blantyre Malawi
Prof. David Lissauer Malawi Liverpool Wellcome Blantyre Malawi
Dr Effie Chipeta College of Medicine Blantyre Malawi
Dr Luis Gadama College of Medicine Blantyre Malawi
Dr Amelia Crampin MEIRU Lilongwe 3 Malawi
Dr. Martha Masamba College of Medicine Blantyre Malawi
Dr Elizabeth Chodoza Kamuzu College of Nursing Blantyre Malawi
Dr. Catherine Mkandawire Lusaka Apex Medical University and Levy Mwanawasa University Teaching Hospital Lusaka 10101 Zambia
Prof. Everist Njelesani Lusaka Apex Medical University and Levy Mwanawasa University Teaching Hospital Lusaka 10101 Zambia
Dr. Jean Desire Kabamba Lusaka Apex Medical University and Levy Mwanawasa University Teaching Hospital Lusaka 10101 Zambia
Dr. Mulaya Mubambe Lusaka Apex Medical University and Levy Mwanawasa University Teaching Hospital Lusaka 10101 Zambia
Dr Muriel Syacumpi Lusaka Apex Medical University and Levy Mwanawasa University Teaching Hospital Lusaka 10101 Zambia
Dr. Alexandra Viner University of Edinburgh College of Medicine and Veterinary Medicine 47 Little France Crescent Edinburgh EH16 4TJ United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alinane Linda Nyondo Mipando lmipando@mlw.mw 2651874377 Private Bag 360 Chichiri
City Postal code Country Position/Affiliation
Blantyre Malawi Health systems Researcher
Role Name Email Phone Street address
Scientific Enquiries Jane Norman jane.e.norman@bristol.ac.uk 441174282339 5 Tyndall Avenue
City Postal code Country Position/Affiliation
Bristol BS8 1UD United Kingdom Dean Faculty of Health Sciences
Role Name Email Phone Street address
Principal Investigator Peter Mwaba pbmwaba2000@gmail.com +260079519308 Lusaka Apex Medical University and Levy Mwanawasa University Teaching Hospital, Great East Road,
City Postal code Country Position/Affiliation
Lusaka 10101 Zambia Obstetrician
Role Name Email Phone Street address
Public Enquiries Patricia Munthali pmunthalikhomani@mlw.mw 26501812423 Queen Elizabeth Central Hospital PO Box 30096
City Postal code Country Position/Affiliation
Blantyre 0 Malawi Project Coordinator Malawi
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The study data will be shared with others upon request and will be made available at a later date. Informed Consent Form,Study Protocol Anticipated June 2022 Controlled access on behalf of the DIPLOMATIC Group will be provided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.ed.ac.uk/centre-reproductive-health/diplomatic-study No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information