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Improving antenatal care using WHO recommendations: an implementation research study in Africa and India

Implementation research on the WHO Antenatal Care Guidelines adapted to country context for improved quality of care – India & Burkina Faso, and implementation research on the WHO Antenatal Care Guidelines adapted to country context: Enhanced quality service delivery through a digitalized module – Rwanda & Zambia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16610902
Enrollment
37440
Registered
2022-05-27
Start date
2022-06-17
Completion date
Unknown
Last updated
2025-03-10

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

Conditions

antenatal care Pregnancy and Childbirth

Interventions

The study has two main intervention layers: 1. The first layer is the ANC package adapted by each country or state (in India the study will be conducted in Assam and Tamil Nadu states only), 2. The se

Sponsors

World Health Organization
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Health-workers at selected facilities. 2. Women presenting for their first ANC contact who provide consent.

Exclusion criteria

Exclusion criteria: 1. Health facilities where the management does not agree to participate in the study. 2. Pregnant women who do not provide consent (all study components). 3. Health workers who do not consent (qualitative components). 4. Women who do not reside in the catchment area of selected health care facilities. (India) 5. Women who also sought ANC services from non-public health platforms like private sector providers (Rwanda). 6. For the cohort study component in Burkina Faso and India, women at more than 16- or 20-weeks gestation, respectively, will be excluded. 7. For the cohort study, women with pre-identified complications will be excluded.

Design outcomes

Primary

MeasureTime frame
Quantitative data (adherence & early initiation of ANC) The primary outcomes or indicators of interest, which will be measured for assessing the impact of national/state specific packages, vary across each country: 1. Syphilis testing at first contact/during pregnancy 2. ANC 1 within 12 weeks 3. 8 ANC contacts 4. IFA consumption for 90+ days 5. Hemoglobin (Hb) screened at first ANC contact 6. Total number of ANC contacts 7. BP measurement at 1st contact Qualitative data (acceptability) Additionally, the research team will develop measures based on qualitative data gathered from health workers and women, to gauge acceptability of the national/state-ANC package and its component. To understand whether the adapted state-specific ANC packages are acceptable to and create value for women as well as health care providers, we will collect and analyze qualitative data. Qualitative components will entail in-depth interviews and focus group discussions with purposively identified participants from stakeholder groups. The stakeholder groups that are relevant for this study objective vary across each country: 1. Pregnant women who seek ANC at selected facilities or within the selected facilities' catchment areas. 2. Husbands or mothers-in-law (household decision maker) from the selected catchment areas. 3. Selected community representatives or champions for maternal health. 4. Health workers providing ANC services at selected facilities or within catchment area of the selected facilities. 5. Health facility managers of selected facilities 6. Health workers providing ANC services at selected facilities using the ANC digital tool 7. Community health workers rendering services within catchment area of selected health facilities. 8. Government health officials (program managers) managing the maternal health program at district/state or national level.

Secondary

MeasureTime frame
The secondary outcomes or indicators of interest, which will be measured for assessing the impact of national/state-specific packages, vary across each country (for India and Burkina Faso, some of these outcomes will be measured from the embedded cohort study only): 1. Ultrasound scan before 24 weeks 2. HB check at 1st contact 3. Tested/screened for maternal infections early in pregnancy 4. BP, and weight checked at least once during pregnancy/in each trimester 5. IFA consumption for 90+ days 6. Preventive anthelminthic treatment 7. Gestational weight gain during pregnancy 8. Tested for GDM in pregnancy 9. Screening for Anemia at ANC 1 10. Screening for Malnutrition at ANC 1 11. >8 ANC contacts 12. 4 ANC contacts 13. IPTp treatment for malaria (all three doses) 14. Women diagnosed with maternal infections (HIV, malaria, TB, hepatitis) initiated on treatment 15. Women diagnosed with GDM in pregnancy initiated on treatment Training and supervision needs will be documented and evaluated through the monitoring of the co-interventions. The implementation of the updated national/state level ANC package of interventions will further document the implementation of the programme to understand to what extent the co-interventions were performed as intended and factors that inhibited or promoted effectiveness. Project officers will conduct facility readiness assessments at all the study sites using a standard process evaluation form for monitoring at the beginning of each study period. The evaluation form will include items for measuring the readiness of study facilities in terms of drugs, equipment, laboratory reagents, testing kits, etc., in addition to training and supervision needs. This will be done through analysis of data that will be collected for monitoring the implementation of adapted packages using an adapted version of WHO Programme Reporting Standards. Costing data will also be gathered during the cohort study exit interviews with pregnant women. The cost p

Countries

Burkina Faso, India, Rwanda, Zambia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 10, 2026