PANDA e-health for antenatal care

INTERVENTION: 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 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. The intervention will be compared with ‘usual care’ for pregnant women attending the control facilities for antenatal care. This will include history taking and screening using an antenatal card, which the health worker completes. CONDITION: PANDA will include pregnant women attending antenatal care to collect data on maternal and newborn care outcomes ; Pregnancy and Childbirth PRIMARY OUTCOME: 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 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 Minis SECONDARY OUTCOME: 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 increased the number of antenatal contacts between woman and providers from the perspectives of women, partners and healthcare workers measured using semi structured qualitative interviews during the course of the trial. ; 10. Implementation strategy/ies for scale‐up and dissemination of PANDA e‐health system in other districts and region in Tanzania measured using baseline and monthly site logs; observation grid and checklists and semi structured qualitative interviews health workers and key informants during the course of the trial