A multicountry study to establish rates for pregnancy and neonatal outcomes in low- and middle-income regions
3
Issued Date
2026-12-01
Resource Type
eISSN
14712393
Scopus ID
2-s2.0-105043451784
Pubmed ID
41535781
Journal Title
BMC Pregnancy and Childbirth
Volume
26
Issue
1
Rights Holder(s)
SCOPUS
Bibliographic Citation
BMC Pregnancy and Childbirth Vol.26 No.1 (2026)
Suggested Citation
Tullio A.N., Yanni E., Coutinho C.M., Sivapatham L., Lee C.M.F., Pallem S., Pu Y., Akawung A., Kim J.H., Henry O., Mussi-Pinhata M.M., Ahmed K., del Carmen Flores Acosta C., Reyes O., Abadía de Regalado I., Arias Fernandez D.A., Aurpibul L., Taher S.W., Caccavo J., Ceballos A., Pichailuck C., D’Andrea Nores U., De Leon T., De Bernardi M., Dieser P., D’Silva E.C., Falaschi A., Fry S., Gentile A., Teo I.H., Kotze S., Lopez-Medina E., Luca R., Lucion M.F., Mantaring J.B.I.V., Marin B., Moelo M., Pinto J., Puthanakit T., Roa M.F., Rodriguez Brieschke M.T., Rodriguez C.E., Rodriguez Niño J.N., Schwarzbold A.V., Sierra Garcia A., Soon R., Tinoco J.C., Velásquez Penagos J.A., Zaman K., Dos Santos G. A multicountry study to establish rates for pregnancy and neonatal outcomes in low- and middle-income regions. BMC Pregnancy and Childbirth Vol.26 No.1 (2026). doi:10.1186/s12884-025-08012-1 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/117851
Title
A multicountry study to establish rates for pregnancy and neonatal outcomes in low- and middle-income regions
Author(s)
Tullio A.N.
Yanni E.
Coutinho C.M.
Sivapatham L.
Lee C.M.F.
Pallem S.
Pu Y.
Akawung A.
Kim J.H.
Henry O.
Mussi-Pinhata M.M.
Ahmed K.
del Carmen Flores Acosta C.
Reyes O.
Abadía de Regalado I.
Arias Fernandez D.A.
Aurpibul L.
Taher S.W.
Caccavo J.
Ceballos A.
Pichailuck C.
D’Andrea Nores U.
De Leon T.
De Bernardi M.
Dieser P.
D’Silva E.C.
Falaschi A.
Fry S.
Gentile A.
Teo I.H.
Kotze S.
Lopez-Medina E.
Luca R.
Lucion M.F.
Mantaring J.B.I.V.
Marin B.
Moelo M.
Pinto J.
Puthanakit T.
Roa M.F.
Rodriguez Brieschke M.T.
Rodriguez C.E.
Rodriguez Niño J.N.
Schwarzbold A.V.
Sierra Garcia A.
Soon R.
Tinoco J.C.
Velásquez Penagos J.A.
Zaman K.
Dos Santos G.
Yanni E.
Coutinho C.M.
Sivapatham L.
Lee C.M.F.
Pallem S.
Pu Y.
Akawung A.
Kim J.H.
Henry O.
Mussi-Pinhata M.M.
Ahmed K.
del Carmen Flores Acosta C.
Reyes O.
Abadía de Regalado I.
Arias Fernandez D.A.
Aurpibul L.
Taher S.W.
Caccavo J.
Ceballos A.
Pichailuck C.
D’Andrea Nores U.
De Leon T.
De Bernardi M.
Dieser P.
D’Silva E.C.
Falaschi A.
Fry S.
Gentile A.
Teo I.H.
Kotze S.
Lopez-Medina E.
Luca R.
Lucion M.F.
Mantaring J.B.I.V.
Marin B.
Moelo M.
Pinto J.
Puthanakit T.
Roa M.F.
Rodriguez Brieschke M.T.
Rodriguez C.E.
Rodriguez Niño J.N.
Schwarzbold A.V.
Sierra Garcia A.
Soon R.
Tinoco J.C.
Velásquez Penagos J.A.
Zaman K.
Dos Santos G.
Author's Affiliation
Universidade de São Paulo
Universidad de Buenos Aires
Universidade Federal de Minas Gerais
University of the Witwatersrand, Johannesburg
Stellenbosch University
Chiang Mai University
Universidade Federal de Santa Maria
Universidad de Los Andes, Colombia
GlaxoSmithKline, USA
Siriraj Hospital
Universidad del Valle, Cali
International Centre for Diarrhoeal Disease Research Bangladesh
University of the Philippines Manila
AbbVie
Faculty of Medicine, Chulalongkorn University
AstraZeneca Pharmaceuticals LP
Faculty of Health Sciences
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Fundacion Santa Fe de Bogota
Hospital de Ninos Ricardo Gutierrez
GlaxoSmithKline Pharmaceuticals SA/NV
Sarawak General Hospital
Hospital De San José, Bogotá, Colombia
Centro Médico Imbanaco
Hospital Universitario San Vicente Fundación
Hospital Santojanni, Buenos Aires
Hospital General de Durango
Ampang Hospital
Hospital Interzonal General de Agudos Dr. Diego Paroissien
Hospital Santo Tomás
Setshaba Research Centre
Sabah Women and Children's Hospital
Synergy Biomed Research Institute
Dynavax Technologies
Ampang Hospital
Simpang Kuala Health Clinic
Centro de Estudios en Infectología Pediátrica CEIP
Sistema Nacional de Investigadores de Panamá (SNI)
Hosp. Gral. de Agudos F. Santojanni
Centro de Vacunación Internacional S.A. (CEVAXIN)
UMA Hospital Ramón Carrillo
Instituto Medico Rio Cuarto
Maternity Hospital José Domingo De Obaldia
Policentro de Salud de Juán Diaz
Synexus Stanza Clinical Research Centre
Universidad de Buenos Aires
Universidade Federal de Minas Gerais
University of the Witwatersrand, Johannesburg
Stellenbosch University
Chiang Mai University
Universidade Federal de Santa Maria
Universidad de Los Andes, Colombia
GlaxoSmithKline, USA
Siriraj Hospital
Universidad del Valle, Cali
International Centre for Diarrhoeal Disease Research Bangladesh
University of the Philippines Manila
AbbVie
Faculty of Medicine, Chulalongkorn University
AstraZeneca Pharmaceuticals LP
Faculty of Health Sciences
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Fundacion Santa Fe de Bogota
Hospital de Ninos Ricardo Gutierrez
GlaxoSmithKline Pharmaceuticals SA/NV
Sarawak General Hospital
Hospital De San José, Bogotá, Colombia
Centro Médico Imbanaco
Hospital Universitario San Vicente Fundación
Hospital Santojanni, Buenos Aires
Hospital General de Durango
Ampang Hospital
Hospital Interzonal General de Agudos Dr. Diego Paroissien
Hospital Santo Tomás
Setshaba Research Centre
Sabah Women and Children's Hospital
Synergy Biomed Research Institute
Dynavax Technologies
Ampang Hospital
Simpang Kuala Health Clinic
Centro de Estudios en Infectología Pediátrica CEIP
Sistema Nacional de Investigadores de Panamá (SNI)
Hosp. Gral. de Agudos F. Santojanni
Centro de Vacunación Internacional S.A. (CEVAXIN)
UMA Hospital Ramón Carrillo
Instituto Medico Rio Cuarto
Maternity Hospital José Domingo De Obaldia
Policentro de Salud de Juán Diaz
Synexus Stanza Clinical Research Centre
Corresponding Author(s)
Other Contributor(s)
Abstract
Background: Maternal vaccines can reduce the burden of diseases for both mother and neonate. The development and implementation of such vaccines require a thorough interpretation of safety data and standardized disease case definitions. This study aimed to evaluate the current rates for adverse pregnancy outcomes, maternal and neonatal events of interest (EOIs) that will be informative for preparing future phase III clinical trials on maternal vaccines conducted in low- and middle-income countries and further assisting in safety data interpretation (e.g., monitoring potential safety signals in clinical trials, and/or helping with the causality assessments of adverse events following immunization). Methods: We performed a prospective cohort study on healthy 18–45-year-old women, with singleton, low-risk pregnancies, with a gestational age of ≥24<sup>0/7</sup> weeks at enrollment and ≤27<sup>6/7</sup> weeks at first visit, and their neonates. The study was conducted between 2019–2021 in 10 countries that were considered low- and middle-income countries by the World Bank Group at the time the study was designed. All pregnancy-related outcomes and maternal EOIs occurring from enrollment up to 42 days post-delivery and neonatal EOIs occurring within the first 28 days after birth were recorded. Results: Of 2311 pregnant women and 2181 neonates enrolled, 2222 and 2094 were included in the analyses, respectively. Most livebirths (2088 [94.0%]) were without apparent congenital anomalies. Preterm delivery (166 [7.5%]), non-reassuring fetal status (137 [6.2%]), and hypertensive disorders of pregnancy (125 [5.6%]) were the most frequently reported EOIs related to pregnancy. The most frequent neonatal EOIs were low birthweight (including very low birthweight) (156 [7.4%]), preterm birth (141 [6.7%]), small for gestational age (111 [5.3%]), and congenital anomalies (103 [4.9%], including mainly major external structural defects, as well as detected internal and functional defects). Overall, there were similar frequencies in pregnancy outcomes, pregnancy-related and neonatal EOIs across countries, although some variation in the reporting rate was noted. Conclusion: This multicountry study contributes to establishing the most recent background rates for pregnancy outcomes, maternal and neonatal EOIs in low- and middle-income regions. The clinical relevance in the context of the safety assessment in future trials will be applied. Trial registration: NCT03614676 (03/08/2018).