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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202402654300175 Date of Registration: 21/02/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title PANDA
Official scientific title Evaluation of the PANDA e-health system as a tool to increase antenatal contacts and improve perinatal outcomes in Tanzania: A pragmatic cluster randomised controlled trial
Brief summary describing the background and objectives of the trial Background: In Tanzania, most women attend one antenatal visit but only half attend four or more. Women value the importance of antenatal care but their choice to attend subsequent visits is highly influenced by the visit’s contents and how providers approached and treat them during the visit. In recent years, applications and software have developed to support provision of healthcare services and newborn care. Through these e-health solutions health professionals can be facilitated in the diagnosis and treatment of complications early in pregnancy and are supported in providing health education. The interactive nature of some mobile solutions facilitates provision of respectful care and better communication between the woman and the health professional, encouraging continuous attendance to visits. One mobile solution is the Pregnancy and Newborn Diagnostic Assessment (PANDA) e-health system, which we have tested in a feasibility study, using a pre- and post-test in two facilities in Manyara region. Eighty women were recruited in the control phase (usual care) and 80 in the intervention phase (PANDA package). This evaluation confirmed feasibility with >90% recruitment and retention in the study. Lessons learnt during the feasibility phase have been incorporated into protocol development. Aim: To assess the effectiveness of the Pregnancy and Newborn Diagnostic Assessment (PANDA) e-health system, including respectful care prompts, to increase the number of antenatal contacts between women and health providers and reduce episodes of severe perinatal morbidity and mortality in Tanzania. Method: We will conduct a cluster randomised controlled trial across 16 maternity facilities in Manyara, Tanzania, including 1612 women who start attending antenatal visits before 28 weeks. A concurrent process evaluation will assess facilitators and barriers to implementation and generalisability to other settings and include qualitative data collection of interviews (n=108).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PANDA
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial evaluation of e-health system
Anticipated trial start date 01/01/2024
Actual trial start date
Anticipated date of last follow up 30/06/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 1720
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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
Parallel: different groups receive different interventions at same time during study Randomised Dynamic (adaptive) random allocation such as minimization Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group PANDA Intervention Every antenatal care visit from booking until delivery. Anticipated 4 visits or more. Women enrolled at initial visit from 12 weeks gestation up to max 28 weeks and followed up for approx. 30 weeks (maximum), majority of participants will enrol at 20 weeks and will be followed up for 22 weeks. Intervention first visit will be 30-45 minutes and subsequent visits will be 10-15 minutes. The Pregnancy and Newborn Diagnostic Assessment (PANDA) e-health system. The intervention comprises of three key components, making up the PANDA Care Package (Figure 2): 1) The PANDA app – icon-based Android application, 2) Point of Care testing diagnostic tools, 3) The Medical Unit– java web-based database hosted inside the referral hospital. This study will include antenatal care at the health care units only with no community visits to antenatal women. 806
Control Group Usual Care Women will be enrolled at the initial antenatal care visit from 12 weeks gestation up to max 28 weeks and followed up for approx. 30 weeks (maximum), although majority of participants will enrol at 20 weeks and will be followed up for 22 weeks. First visit approx. 10-15 minutes and subsequent visits 5-10 minutes. The control group of pregnant women will receive usual antenatal care which includes history taking of demographic and clinical data and screening tests/results recorded in the antenatal care register and antenatal card. 806 Dose Comparison
Control Group Process evaluation Key informant interviews with stakeholders 2 in total, 1 interview within 3 months from start of trial, 1 within 3 months from end of trial Each interview will last between 45 min to 1 hour 30 minutes. One to one interview with policy makers to explore the current status of policies and practice in maternal health in Tanzania. 8 Dose Comparison
Control Group Process evaluation Semi structured interview with women 4 interviews in total at each site at 2 timepoints (after 1 ANC visit and after 4 visits) Each interview will last between 45min to 1 hour 30 mins One to one interview with women to evaluate their experience and satisfaction with care received during first and subsequent visits 32 Dose Comparison
Experimental Group Process evaluation Semistructured interview with women 4 interviews in total at each site at 2 timepoints (after 1 ANC visit and after 4 visits) Each interview will last between 45min to 1hour 30 mins One to one interview with women to evaluate their experience and satisfaction with care received through PANDA E-health system 32
Control Group Process evaluation Semistructured interview with partners 1 interview after attending at least 1 ANC with their partner The Interview will last between 45min to 1hour 30 mins One to one interview with partners to evaluate their experience and satisfaction with care received during ANC visits 8 Dose Comparison
Experimental Group Process evaluation Semistructured interview with partners 1 interview after attending at least 1 ANC delivered through PANDA with their partner The interview will last between 45min to 1hour 30 min One to one interview with partners to evaluate their experience and satisfaction with PANDA care 8
Control Group Process evaluation semistructured interview with health workers 2 interviews at 2 timepoints (within 3 months from start of trial and towards the end of trial) Each interview will last between 45min to 1hour 30 mins One to one interview with health workers’ to explore their perspectives of delivering ANC to women and being involved in this study 10 Dose Comparison
Experimental Group Process evaluation semistructured interview with health workers 2, 1 interview within 3 months from start of trial 1 interview towards the end of trial Each interview will last between 45min to 1hour 30 mins One to one interview with health workers’ to explore their perspective of PANDA training, use of PANDA at the beginning and after been used routinely 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Main trial inclusion: Pregnant women (aged 18 and above) booked or planning to start their ANC at the study sites in the first and second trimester, regardless of parity. Process Evaluation inclusion: Pregnant women (age 18 and above) recruited into the study (both control and intervention arms) who: • Have actively engaged in antenatal care (>4 more visits) • Have not actively engaged in antenatal care (< 4 visits) • Partners of women (aged 18 and above) recruited into the study, who also attended at least one ANC visit with their partner. • Midwives delivering routine ANC in control sites. • Midwives using PANDA to deliver ANC to pregnant women in intervention sites. • Obstetricians / Senior Medical Officers from the Haydom Referral Hospital, in charge of validating the ANC visits received in the Medical Unit from the intervention facilities. • District health officers, Regional Health officers, representative of Ministry of Health and other key stakeholders involved in prenatal care in Manyara Region and Tanzania Main trial exclusion: • Women on ‘high risk’ pathway. • Women unable/declining consent Process Evaluation exclusion: - Women who are already established on a high-risk pathway prior to recruitment. High-risk refers to women who have previous pregnancy or health complications for example hypertension, diabetes, epilepsy, thyroid disease, heart or blood disorders, poorly controlled asthma and infections, requiring referral to a higher level of care - Women unwilling to be interviewed, despite their visit conducted through PANDA. - Women who refuse to have their subsequent visits completed through PANDA - Midwives moved to a difference facility, not involved in the trial. - Midwives not in charge of ANC. - Obstetrician / Senior Medical officers unwilling to be interviewed, despite using the Medical Unit. - Key stakeholders unwilling to be interviewed despite their engagement with the PANDA research study. Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 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 19/10/2023 Liverpool School of Tropical Medicine
Ethics Committee Address
Street address City Postal code Country
Pembroke Place Liverpool L3 5QA United Kingdom
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 18/01/2024 National Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive Dar Es Salaam P.O.BOX 9 Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • Number of women who have >4 antenatal visits • Rate of severe perinatal morbidity and mortality (NICU admission >24hours, Apgar Score < 7 at 5 min, stillbirth, early neonatal death) 2-6 weeks post birth
Secondary Outcome • Maternal antenatal experience • Maternal perceptions of respectful care • Number of antenatal referrals to central facility • Intrapartum transfer rates • Maternal clinical outcomes including mode of birth, transfusion, anaemia, severe pre-eclampsia, postpartum haemorrhage, sepsis, breastfeeding, WHO severe morbidity scale and maternal mortality (up to 6 weeks PN). • Neonatal clinical outcomes including components of the severe perinatal morbidity outcome. 6 weeks postbirth
Secondary Outcome Cost-effectiveness outcomes • Cost to implement PANDA (including training and device provision) • Incremental cost-effectiveness ratios (e.g. cost per woman with >4 antenatal visits) 6 weeks postbirth
Secondary Outcome Process evaluation outcomes - How PANDA has been implementation in terms of fidelity, ‘dose’, reach and adaptation made in the study context - Why the use of PANDA e-health system has increased / not increased the number of antenatal contacts between woman and providers from the perspectives of women, partners and healthcare workers. - Implementation strategy/ies for scale-up and dissemination of PANDA e-health system in other districts and region in Tanzania 6 weeks postbirth
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Haydom Lutheran Hospital PO Box 9000, Mbulu District Manyara Tanzania
Bassodesh Dispensary Hanang District Manyara Region Tanzania
Bassotu Dispensary Bassotu Ziwani Manyara Region Tanzania
Getanuwas Dispensary Hanang District Manyara Region Tanzania
Murjanda Dispensary Hanang District Manyara Region Tanzania
Laghanga Dispensary Hanang District Manyara Region Tanzania
Gendabi Health Centre Hanang District Manyara Region Tanzania
Endahargadat Dispensary Mbulu District Manyara Region Tanzania
Kidarafa Dispensary Mkalama District Singida Region Tanzania
St Agnes Mwanga Mkalama District Singida Region Tanzania
Mewadan Dispensary Mbulu District Manyara Region Tanzania
Haydarer Dispensary Mbulu District Manyara Region Tanzania
Maretadu Dispensary Mbulu District Manyara Region Tanzania
Labay Pentecostal Dispensary Mbulu District Manyara Region Tanzania
Bashay Dispensary Mbulu District Manyara Region Tanzania
Masqaroda Dispensary Mbulu District Manyara Region Tanzania
St Alois Health Center Mbulu District Manyara Region Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institute of Health and Care Research NIHR Alpha House - Enterprise Road Southampton SO16 7NS United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Liverpool School of Tropical Medicine Pembroke Place Liverpool L3 5QA United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Haydom Lutheran Hospital Mbulu Manyara Tanzania
Terre Innovative Healthcare Via De Caro 104 Catania Italy
Catholic University of Health and Allied Sciences P.O. Box 1464 Mwanza Tanzania
University of Liverpool Brownlow Hill Liverpool L69 3BX United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Tina Lavender tina.lavender@lstmed.ac.uk +441518321689 Pembroke Place
City Postal code Country Position/Affiliation
Liverpool L3 5QA United Kingdom Professor of Maternal and Newborn Health and Chief Investigator of PANDA Trial
Role Name Email Phone Street address
Scientific Enquiries Tina Lavender tina.lavender@lstmed.ac.uk +441518321689 Pembroke Place
City Postal code Country Position/Affiliation
Liverpool L3 5QA United Kingdom Professor of Maternal and Newborn Health and Chief Investigator of PANDA Trial
Role Name Email Phone Street address
Principal Investigator Paschal Mdoe pfmdoe@gmail.com +2550784550041 Haydom Lutheran Hospital
City Postal code Country Position/Affiliation
Manyara Tanzania Obstetrician and Principal Investigator for PANDA Trial
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes It is anticipated that quantitative data collected in this study will be suitable for unqualified access to researchers to facilitate secondary analysis. Study Protocol Once analyses of the data have been completed for publication data will be published on a compliant data sharing site such as the Clinical Study Data Request (CSDR). Data will be available for sharing within 2 years of the study ending. Datasets generated and/or analysed during the trial will be available on request from the sponsor, Liverpool School of Tropical Medicine. The Chief Investigator will make the decision to supply research data to potential new users and a statistician will confirm any exclusions required. Data request forms should be submitted to the Data Manager who will provide data in the required format using secure transfer method i.e SSH portal secure end to end transfer or file encryption (AES 256 bit encryption), shared keys to be transferred separately to data sets.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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