Estimating baseline rates of adverse perinatal and neonatal outcomes using a facility-based surveillance approach: A prospective observational study from the WHO Global Vaccine Safety Multi-Country Collaboration on safety in pregnancy.
Baseline rates
Minimum detectable risk
Neonatal outcomes
Perinatal outcomes
Pharmacovigilance
Surveillance
Vaccines
Journal
EClinicalMedicine
ISSN: 2589-5370
Titre abrégé: EClinicalMedicine
Pays: England
ID NLM: 101733727
Informations de publication
Date de publication:
Aug 2022
Aug 2022
Historique:
received:
15
10
2021
revised:
20
05
2022
accepted:
23
05
2022
entrez:
30
6
2022
pubmed:
1
7
2022
medline:
1
7
2022
Statut:
epublish
Résumé
Most perinatal and neonatal deaths occur in low- and middle-income countries (LMICs), yet, quality data on burden of adverse outcomes of pregnancy is limited in such countries. A network of 21 maternity units, across seven countries, undertook surveillance for low birthweight, preterm birth, small for gestational age (SGA), stillbirths, congenital microcephaly, in-hospital neonatal deaths, and neonatal infections in a cohort of over 85,000 births from May 2019 - August 2020. For each outcome, site-specific rates per 1,000 livebirths (or per 1,000 total births for stillbirth) and 95% confidence intervals (CI) were calculated. Descriptive sensitivity analysis was conducted to gain insight regarding underreporting of four outcomes at 16 sites. Estimated rates varied across countries and sites, ranging between 43·3-329·5 and 21·4-276·6/1000 livebirths for low birthweight and preterm birth respectively and 11·8-81/1,000 livebirths for SGA. No cases of congenital microcephaly were reported by three sites while the highest estimated rate was 13/1,000 livebirths. Neonatal infection and neonatal death rates varied between 1·8-73 and 0-59·9/1000 livebirths respectively while stillbirth rates ranged between 0-57·1/1000 total births across study sites. Results from the sensitivity analysis confirmed the underreporting of congenital microcephaly and SGA in our study. Our study establishes site-specific baseline rates for important adverse perinatal and neonatal outcomes and addresses a critical evidence gap towards improved monitoring of benefits and risks of emerging pregnancy and neonatal interventions. The study was sponsored by the World Health Organization with funding from the Bill and Melinda Gates Foundation.
Sections du résumé
Background
UNASSIGNED
Most perinatal and neonatal deaths occur in low- and middle-income countries (LMICs), yet, quality data on burden of adverse outcomes of pregnancy is limited in such countries.
Methods
UNASSIGNED
A network of 21 maternity units, across seven countries, undertook surveillance for low birthweight, preterm birth, small for gestational age (SGA), stillbirths, congenital microcephaly, in-hospital neonatal deaths, and neonatal infections in a cohort of over 85,000 births from May 2019 - August 2020. For each outcome, site-specific rates per 1,000 livebirths (or per 1,000 total births for stillbirth) and 95% confidence intervals (CI) were calculated. Descriptive sensitivity analysis was conducted to gain insight regarding underreporting of four outcomes at 16 sites.
Findings
UNASSIGNED
Estimated rates varied across countries and sites, ranging between 43·3-329·5 and 21·4-276·6/1000 livebirths for low birthweight and preterm birth respectively and 11·8-81/1,000 livebirths for SGA. No cases of congenital microcephaly were reported by three sites while the highest estimated rate was 13/1,000 livebirths. Neonatal infection and neonatal death rates varied between 1·8-73 and 0-59·9/1000 livebirths respectively while stillbirth rates ranged between 0-57·1/1000 total births across study sites. Results from the sensitivity analysis confirmed the underreporting of congenital microcephaly and SGA in our study.
Interpretation
UNASSIGNED
Our study establishes site-specific baseline rates for important adverse perinatal and neonatal outcomes and addresses a critical evidence gap towards improved monitoring of benefits and risks of emerging pregnancy and neonatal interventions.
Funding
UNASSIGNED
The study was sponsored by the World Health Organization with funding from the Bill and Melinda Gates Foundation.
Identifiants
pubmed: 35770255
doi: 10.1016/j.eclinm.2022.101506
pii: S2589-5370(22)00236-X
pmc: PMC9234094
doi:
Types de publication
Journal Article
Langues
eng
Pagination
101506Subventions
Organisme : World Health Organization
ID : 001
Pays : International
Informations de copyright
© 2022 World Health Organization.
Déclaration de conflit d'intérêts
Margarita Riera-Montes (P95) & Christine Guillard Maure (WHO) declare that their institutions received funding support for this manuscript from the WHO and the Bill & Melinda Gates Foundation respectively. All the remaining authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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