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.

Apoorva Sharan; Anke L Stuurman; Shubhashri Jahagirdar; Varalakshmi Elango; Margarita Riera-Montes; Neeraj Kumar Kashyap; Jorne Biccler; Ramesh Poluru; Narendra Kumar Arora; Matthews Mathai; Punam Mangtani; Hugo Devlieger; Steven Anderson; Barbee Whitaker; Hui-Lee Wong; Allisyn Moran; Christine Guillard Maure

doi:10.1016/j.eclinm.2022.101506

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.

Apoorva Sharan, Anke L Stuurman, Shubhashri Jahagirdar, Varalakshmi Elango, Margarita Riera-Montes, Neeraj Kumar Kashyap, Jorne Biccler, Ramesh Poluru, Narendra Kumar Arora, Matthews Mathai, Punam Mangtani, Hugo Devlieger, Steven Anderson, Barbee Whitaker, Hui-Lee Wong, Allisyn Moran, Christine Guillard Maure

International Public Health

Liverpool School of Tropical Medicine

Research output: Contribution to journal › Article › peer-review

2 Citations (Scopus)

Abstract

Background

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

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

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

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.

Original language	English
Article number	101506
Pages (from-to)	e101506
Journal	eClinicalMedicine
Volume	50
Early online date	17 Jun 2022
DOIs	https://doi.org/10.1016/j.eclinm.2022.101506
Publication status	Published - 17 Jun 2022

Keywords

Baseline rates
Minimum detectable risk
Neonatal outcomes
Perinatal outcomes
Pharmacovigilance
Surveillance
Vaccines

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Sharan, A., Stuurman, A. L., Jahagirdar, S., Elango, V., Riera-Montes, M., Kashyap, N. K., Biccler, J., Poluru, R., Arora, N. K., Mathai, M., Mangtani, P., Devlieger, H., Anderson, S., Whitaker, B., Wong, H.-L., Moran, A., & Maure, C. G. (2022). 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. eClinicalMedicine, 50, e101506. Article 101506. https://doi.org/10.1016/j.eclinm.2022.101506

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title = "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.",

abstract = "BackgroundMost 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.MethodsA 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.FindingsEstimated 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.InterpretationOur 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.",

keywords = "Baseline rates, Minimum detectable risk, Neonatal outcomes, Perinatal outcomes, Pharmacovigilance, Surveillance, Vaccines",

author = "Apoorva Sharan and Stuurman, \{Anke L\} and Shubhashri Jahagirdar and Varalakshmi Elango and Margarita Riera-Montes and Kashyap, \{Neeraj Kumar\} and Jorne Biccler and Ramesh Poluru and Arora, \{Narendra Kumar\} and Matthews Mathai and Punam Mangtani and Hugo Devlieger and Steven Anderson and Barbee Whitaker and Hui-Lee Wong and Allisyn Moran and Maure, \{Christine Guillard\}",

year = "2022",

month = jun,

day = "17",

doi = "10.1016/j.eclinm.2022.101506",

language = "English",

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pages = "e101506",

journal = "eClinicalMedicine",

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Sharan, A, Stuurman, AL, Jahagirdar, S, Elango, V, Riera-Montes, M, Kashyap, NK, Biccler, J, Poluru, R, Arora, NK, Mathai, M, Mangtani, P, Devlieger, H, Anderson, S, Whitaker, B, Wong, H-L, Moran, A & Maure, CG 2022, '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.', eClinicalMedicine, vol. 50, 101506, pp. e101506. https://doi.org/10.1016/j.eclinm.2022.101506

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. / Sharan, Apoorva; Stuurman, Anke L; Jahagirdar, Shubhashri et al.
In: eClinicalMedicine, Vol. 50, 101506, 17.06.2022, p. e101506.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - 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.

AU - Sharan, Apoorva

AU - Stuurman, Anke L

AU - Jahagirdar, Shubhashri

AU - Elango, Varalakshmi

AU - Riera-Montes, Margarita

AU - Kashyap, Neeraj Kumar

AU - Biccler, Jorne

AU - Poluru, Ramesh

AU - Arora, Narendra Kumar

AU - Mathai, Matthews

AU - Mangtani, Punam

AU - Devlieger, Hugo

AU - Anderson, Steven

AU - Whitaker, Barbee

AU - Wong, Hui-Lee

AU - Moran, Allisyn

AU - Maure, Christine Guillard

PY - 2022/6/17

Y1 - 2022/6/17

N2 - BackgroundMost 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.MethodsA 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.FindingsEstimated 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.InterpretationOur 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.

AB - BackgroundMost 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.MethodsA 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.FindingsEstimated 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.InterpretationOur 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.

KW - Baseline rates

KW - Minimum detectable risk

KW - Neonatal outcomes

KW - Perinatal outcomes

KW - Pharmacovigilance

KW - Surveillance

KW - Vaccines

U2 - 10.1016/j.eclinm.2022.101506

DO - 10.1016/j.eclinm.2022.101506

M3 - Article

SN - 2589-5370

VL - 50

SP - e101506

JO - eClinicalMedicine

JF - eClinicalMedicine

M1 - 101506

ER -

Sharan A, Stuurman AL, Jahagirdar S, Elango V, Riera-Montes M, Kashyap NK et al. 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. eClinicalMedicine. 2022 Jun 17;50:e101506. 101506. Epub 2022 Jun 17. doi: 10.1016/j.eclinm.2022.101506