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PANDA e-health for antenatal care

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN53107672
Enrollment
2000
Registered
2024-02-16
Start date
2024-02-19
Completion date
Unknown
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PANDA will include pregnant women attending antenatal care to collect data on maternal and newborn care outcomes Pregnancy and Childbirth

Interventions

The Pregnancy and Newborn Diagnostic Assessment (PANDA) e-health system will be used in intervention sites. The intervention comprises of three key components, making up the PANDA Care Package 1. The

Sponsors

Liverpool School of Tropical Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 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: 1. Have actively engaged in antenatal care (>4 more visits) 2. Have not actively engaged in antenatal care (< 4 visits) 3. Partners of women (aged 18 and above) recruited into the study, who also attended at least one ANC visit with their partner. 4. Midwives delivering routine ANC in control sites. 5. Midwives using PANDA to deliver ANC to pregnant women in intervention sites. 6. 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. 7. District health officers, Regional Health officers, representative of Ministry of Health and other key stakeholders involved in prenatal care in Manyara Region and Tanzania

Exclusion criteria

Exclusion criteria: 1. Women on ‘high risk’ pathway 2. Women unable/declining consent

Design outcomes

Primary

MeasureTime frame
1.Number of women who have >4 antenatal visits measured using number of antenatal visits attended prior to birth 2.Rate of severe perinatal morbidity and mortality measured using NICU admission >24hours, Apgar Score < 7 at 5 min, stillbirth, early neonatal death

Secondary

MeasureTime frame
1. Maternal antenatal experience measured using semi-structured qualitative interviews conducted with women during their antenatal care period on the trial and up to 2-6 weeks post-birth 2. Maternal perceptions of respectful care measured using the Person-Centred Prenatal Care Scale Exit questionnaire administered at study exit visit post-birth 3. Number of antenatal referrals to central facility measured using total number of external referrals for high risk pregnancy collected on site and central unit referral logs at study exit 4. Intrapartum transfer rates central facility measured using referrals data collected on the post-birth form at study exit 5. 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) measured using post-birth, Adverse Events and Serious Adverse Events forms collected during antenatal care visits up to study exit post-birth 6. Neonatal clinical outcomes including components of the severe perinatal morbidity outcome measured using Adverse and Serious Adverse event forms collected during antenatal care visits up to study exit post-birth Cost-effectiveness outcomes: 7. Cost to implement PANDA (including training and device provision) measured using a bespoke resource utilisation questionnaire, which will be completed once by each participating site. The questionnaire captures the resources used by each site to implement the PANDA intervention. Process evaluation outcomes: 8. PANDA implementation in terms of fidelity, ‘dose’, reach and adaptation made in the study context is measured using the baseline and monthly site logs; participant recruitment logs; observation grid and checklists and semi structured qualitative interviews conducted with women, partners, health workers and key informants during the course of the trial 9. Why the use of PANDA e-health system has increased / not incre

Countries

Tanzania

Contacts

Public ContactTina Lavender
tina.lavender@lstmed.ac.uk+44 151 832 1689

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026