Pregnancy outcome documentation in low-resource settings: a multi-country study.
15 affiliations
- 1Centre for Global Health, Charité-Universitätsmedizin Berlin, Berlin, Germany (Hucko, Prauseová, Kampmann).
- 2Department of Infectious Disease Epidemiology and International Health, London School of Hygiene & Tropical Medicine, London, UK (Parker).
- 3Department of Clinical Research, London School of Hygiene & Tropical Medicine, London, UK (Ford and Kampmann).
- 4School of Public Health, Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia (Ford).
- 5Medical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, The Gambia (Nkereuwem and Kampmann).
- 6Alex-Ekwueme Federal University Teaching Hospital Abakaliki (AEFUTHA), Ebonyi State, Nigeria (Madubueze).
- 7Alex-Ekwueme Federal University, Ndufu-Alike Ikwo, Ebonyi State, Nigeria (Madubueze).
- 8Global Health Research and Medical Interventions Institute, Kathmandu, Nepal (Bhattarai).
- 9Department of_Infectious Disease Epidemiology and International Health, London School of Hygiene & Tropical Medicine, London, UK (Bhattarai).
- 10Makerere University Centre for Health and Population Research, Kampala, Uganda (Kajungu).
- 11Division of Epidemiology and Biostatistics, Department of Global Health, Stellenbosch University, Stellenbosch, Cape Town, South Africa (Kajungu).
- 12Kilimanjaro Clinical Research Institute (KCRI), Moshi, Tanzania (Msoka).
- 13Kilimanjaro Christian Medical Centre (KCMCU), Moshi, Tanzania (KCMCU).
- 14Kilimanjaro College of Health and Allied Sciences, School of Nursing, Moshi, Tanzania (Msoka).
- 15Planning and Research Unit, Directorate General of Health Services, Dhaka, Bangladesh (Hossain).
Abstract
Background
As the maternal vaccine portfolio expands, reliable documentation of adverse events of special interest (AESI) is critical for safety surveillance in low- and middle-income countries (LMIC). However, such documentation is often not easily available, even prior to introduction of new vaccines, and background rates are therefore lacking.Methods
Nested within a retrospective multisite analysis of routine maternal health data from six LMICs (Bangladesh, The Gambia, Nepal, Nigeria, Tanzania, and Uganda) from 2019 to 2022, we extracted aggregated monthly counts of vaccination-relevant pregnancy AESI- preterm birth, stillbirth, congenital malformations, neonatal death, and maternal death- and assessed their availability, completeness, and consistency using descriptive analyses. Outcome rates were compared with published country-specific background estimates.Findings
Among 123,867 pregnancies across 27 clinics (totaling 1277 clinic-months) in six LMICs, substantial limitations in pregnancy outcome recording were identified. AESI recording was predominantly paper-based (clinic registers in 92.6% of clinics, maternal-held documents in 51.9%); with use of digital systems in only 14.8% of clinics. Congenital malformations and preterm subcategories were absent in seven of 27 clinics (25.9%). Documentation completeness ranged from 65.2% to 68.9% for preterm birth categories to 96.8% to 98.4% for mortality outcomes (stillbirths, neonatal and maternal deaths). Considerable inter-clinic variability was noted, and observed rates diverged substantially from national background estimates for several pregnancy outcomes.Interpretation
Substantial gaps in documentation of routine clinical data across LMIC underscore the need for linked, standardized, and digital maternal and neonatal outcome documentation to support the safe introduction and surveillance of vaccines administered during pregnancy.
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BibTeX
@article{hucko2026pregnancy,
title = {{Pregnancy outcome documentation in low-resource settings: a multi-country study.}},
author = {Alice Hucko and Jana Prauseová and Edward P K Parker and Rachel Ford and Oluwatosin Nkereuwem and Ugochukwu Madubueze and Suraj Bhattarai and Dan Kajungu and Agnes Msoka and Mir Mobarak Hossain and Beate Kampmann},
journal = {AJOG global reports},
year = {2026},
month = sep,
doi = {10.1016/j.xagr.2026.100696},
url = {https://europepmc.org/article/MED/42898372},
note = {CC BY},
}
RIS
TY - JOUR
TI - Pregnancy outcome documentation in low-resource settings: a multi-country study.
AU - Alice Hucko
AU - Jana Prauseová
AU - Edward P K Parker
AU - Rachel Ford
AU - Oluwatosin Nkereuwem
AU - Ugochukwu Madubueze
AU - Suraj Bhattarai
AU - Dan Kajungu
AU - Agnes Msoka
AU - Mir Mobarak Hossain
AU - Beate Kampmann
PY - 2026
DA - 2026/09/16
JO - AJOG global reports
DO - 10.1016/j.xagr.2026.100696
UR - https://europepmc.org/article/MED/42898372
AB - Background As the maternal vaccine portfolio expands, reliable documentation of adverse events of special interest (AESI) is critical for safety surveillance in low- and middle-income countries (LMIC). However, such documentation is often not easily available, even prior to introduction of new vaccines, and background rates are therefore lacking.Methods Nested within a retrospective multisite analysis of routine maternal health data from six LMICs (Bangladesh, The Gambia, Nepal, Nigeria, Tanzania, and Uganda) from 2019 to 2022, we extracted aggregated monthly counts of vaccination-relevant pregnancy AESI- preterm birth, stillbirth, congenital malformations, neonatal death, and maternal death- and assessed their availability, completeness, and consistency using descriptive analyses. Outcome rates were compared with published country-specific background estimates.Findings Among 123,867 pregnancies across 27 clinics (totaling 1277 clinic-months) in six LMICs, substantial limitations in pregnancy outcome recording were identified. AESI recording was predominantly paper-based (clinic registers in 92.6% of clinics, maternal-held documents in 51.9%); with use of digital systems in only 14.8% of clinics. Congenital malformations and preterm subcategories were absent in seven of 27 clinics (25.9%). Documentation completeness ranged from 65.2% to 68.9% for preterm birth categories to 96.8% to 98.4% for mortality outcomes (stillbirths, neonatal and maternal deaths). Considerable inter-clinic variability was noted, and observed rates diverged substantially from national background estimates for several pregnancy outcomes.Interpretation Substantial gaps in documentation of routine clinical data across LMIC underscore the need for linked, standardized, and digital maternal and neonatal outcome documentation to support the safe introduction and surveillance of vaccines administered during pregnancy.
SN - 2666-5778
ER -