Pregnancy and Childbirth
Conditions
Interventions
Sponsors
Eligibility
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: • 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •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) | — |
Secondary
| Measure | Time frame |
|---|---|
| • 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. ;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) ;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 | — |
Countries
Tanzania
Contacts
Professor of Maternal and Newborn Health and Chief Investigator of PANDA Trial