The global network antenatal corticosteroids trial: Impact on stillbirth

Autores
Goldenberg, Robert L.; Thorsten, Vanessa R.; Althabe, Fernando; Saleem, Sarah; Garces, Ana; Carlo, Waldemar A.; Pasha, Omrana; Chomba, Elwyn; Goudar, Shivaprasad; Esamai, Fabian; Krebs, Nancy F.; Derman, Richard J.; Liechty, Edward A.; Patel, Archana; Hibberd, Patricia L.; Buekens, Pierre; Koso-Thomas, Marion; Miodovnik, Menachem; Jobe, Alan H.; Wallace, Dennis D.; Belizan, Jose; McClure, Elizabeth M.
Año de publicación
2016
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Background: Antenatal corticosteroids are commonly used to reduce neonatal mortality, but most research to date has been in high-resource settings and few studies have evaluated its impact on stillbirth. In the Antenatal Corticosteroids Trial (ACT), a multi-country trial to assess impact of a multi-faceted intervention including antenatal corticosteroids to reduce neonatal mortality associated with preterm birth, we found an overall increase in 28-day neonatal mortality and stillbirth associated with the intervention.METHODS:The ACT was a cluster-randomized trial conducted in 102 clusters across 7 research sites in 6 countries (India [2 sites], Pakistan, Zambia, Kenya, Guatemala and Argentina), comparing an intervention to train birth attendants at all levels of the health system to identify women at risk of preterm birth, administer corticosteroids and refer women at risk. Because of inadequate gestational age dating, the <5(th) percentile birth weight was used as a proxy for preterm birth. A pre-specified secondary outcome of the trial was stillbirth.RESULTS:After adjusting for the pre-trial imbalance in stillbirth rates, the ACT intervention was associated with a non-significant increased risk of stillbirth (aRR 1.08, 95 % CI, 0.99-1.17, p-0.073). Additionally, the stillbirth rate was higher in the term births (1.20 95 % CI 1.06-1.37, 0.004) and among those with signs of maceration (RR 1.18 (1.04-1.35), p = 0.013) in the intervention vs. control clusters. Differences in obstetric care favored the control clusters and maternal infection was likely more common in the intervention clusters.CONCLUSIONS:In this pragmatic trial, limited data were available to identify the causes of the increase in stillbirths in the intervention clusters. A higher rate of stillbirth in the intervention clusters prior to the trial, differences in obstetric care and an increase in maternal infection are potential explanations for the observed increase in stillbirths in the intervention clusters during the trial.
Fil: Goldenberg, Robert L.. Columbia University; Estados Unidos
Fil: Thorsten, Vanessa R.. RTI International; Estados Unidos
Fil: Althabe, Fernando. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Saleem, Sarah. Columbia University; Estados Unidos. Aga Khan University; Pakistán
Fil: Garces, Ana. No especifíca;
Fil: Carlo, Waldemar A.. University of Alabama at Birmingham; Estados Unidos
Fil: Pasha, Omrana. Aga Khan University; Pakistán
Fil: Chomba, Elwyn. University Teaching Hospital; Zambia
Fil: Goudar, Shivaprasad. KLE University’s; India
Fil: Esamai, Fabian. Moi University; Kenia
Fil: Krebs, Nancy F.. University of Colorado School of Medicine; Estados Unidos
Fil: Derman, Richard J.. Christiana Care Health System; Estados Unidos
Fil: Liechty, Edward A.. Indiana University; Estados Unidos
Fil: Patel, Archana. Lata Medical Research Foundation; India
Fil: Hibberd, Patricia L.. Massachusetts General Hospital; Estados Unidos
Fil: Buekens, Pierre. Tulane School of Public Health and Tropical Medicine; Estados Unidos
Fil: Koso-Thomas, Marion. Eunice Kennedy Shriver National Institute of Child Health and Human Development; Estados Unidos
Fil: Miodovnik, Menachem. Eunice Kennedy Shriver National Institute of Child Health and Human Development; Estados Unidos
Fil: Jobe, Alan H.. Cincinnati Children’s Hospital; Estados Unidos
Fil: Wallace, Dennis D.. RTI International; Estados Unidos
Fil: Belizan, Jose. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: McClure, Elizabeth M.. RTI International; Estados Unidos
Materia
stillbirth
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/106839
Acceder
id CONICETDig_0a9e286acbed926987dab249f8c25d30
oai_identifier_str oai:ri.conicet.gov.ar:11336/106839
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling The global network antenatal corticosteroids trial: Impact on stillbirthGoldenberg, Robert L.Thorsten, Vanessa R.Althabe, FernandoSaleem, SarahGarces, AnaCarlo, Waldemar A.Pasha, OmranaChomba, ElwynGoudar, ShivaprasadEsamai, FabianKrebs, Nancy F.Derman, Richard J.Liechty, Edward A.Patel, ArchanaHibberd, Patricia L.Buekens, PierreKoso-Thomas, MarionMiodovnik, MenachemJobe, Alan H.Wallace, Dennis D.Belizan, JoseMcClure, Elizabeth M.stillbirthhttps://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3Background: Antenatal corticosteroids are commonly used to reduce neonatal mortality, but most research to date has been in high-resource settings and few studies have evaluated its impact on stillbirth. In the Antenatal Corticosteroids Trial (ACT), a multi-country trial to assess impact of a multi-faceted intervention including antenatal corticosteroids to reduce neonatal mortality associated with preterm birth, we found an overall increase in 28-day neonatal mortality and stillbirth associated with the intervention.METHODS:The ACT was a cluster-randomized trial conducted in 102 clusters across 7 research sites in 6 countries (India [2 sites], Pakistan, Zambia, Kenya, Guatemala and Argentina), comparing an intervention to train birth attendants at all levels of the health system to identify women at risk of preterm birth, administer corticosteroids and refer women at risk. Because of inadequate gestational age dating, the <5(th) percentile birth weight was used as a proxy for preterm birth. A pre-specified secondary outcome of the trial was stillbirth.RESULTS:After adjusting for the pre-trial imbalance in stillbirth rates, the ACT intervention was associated with a non-significant increased risk of stillbirth (aRR 1.08, 95 % CI, 0.99-1.17, p-0.073). Additionally, the stillbirth rate was higher in the term births (1.20 95 % CI 1.06-1.37, 0.004) and among those with signs of maceration (RR 1.18 (1.04-1.35), p = 0.013) in the intervention vs. control clusters. Differences in obstetric care favored the control clusters and maternal infection was likely more common in the intervention clusters.CONCLUSIONS:In this pragmatic trial, limited data were available to identify the causes of the increase in stillbirths in the intervention clusters. A higher rate of stillbirth in the intervention clusters prior to the trial, differences in obstetric care and an increase in maternal infection are potential explanations for the observed increase in stillbirths in the intervention clusters during the trial.Fil: Goldenberg, Robert L.. Columbia University; Estados UnidosFil: Thorsten, Vanessa R.. RTI International; Estados UnidosFil: Althabe, Fernando. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Saleem, Sarah. Columbia University; Estados Unidos. Aga Khan University; PakistánFil: Garces, Ana. No especifíca;Fil: Carlo, Waldemar A.. University of Alabama at Birmingham; Estados UnidosFil: Pasha, Omrana. Aga Khan University; PakistánFil: Chomba, Elwyn. University Teaching Hospital; ZambiaFil: Goudar, Shivaprasad. KLE University’s; IndiaFil: Esamai, Fabian. Moi University; KeniaFil: Krebs, Nancy F.. University of Colorado School of Medicine; Estados UnidosFil: Derman, Richard J.. Christiana Care Health System; Estados UnidosFil: Liechty, Edward A.. Indiana University; Estados UnidosFil: Patel, Archana. Lata Medical Research Foundation; IndiaFil: Hibberd, Patricia L.. Massachusetts General Hospital; Estados UnidosFil: Buekens, Pierre. Tulane School of Public Health and Tropical Medicine; Estados UnidosFil: Koso-Thomas, Marion. Eunice Kennedy Shriver National Institute of Child Health and Human Development; Estados UnidosFil: Miodovnik, Menachem. Eunice Kennedy Shriver National Institute of Child Health and Human Development; Estados UnidosFil: Jobe, Alan H.. Cincinnati Children’s Hospital; Estados UnidosFil: Wallace, Dennis D.. RTI International; Estados UnidosFil: Belizan, Jose. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: McClure, Elizabeth M.. RTI International; Estados UnidosBioMed Central2016-06info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/106839Goldenberg, Robert L.; Thorsten, Vanessa R.; Althabe, Fernando; Saleem, Sarah; Garces, Ana; et al.; The global network antenatal corticosteroids trial: Impact on stillbirth; BioMed Central; Reproductive Health; 13; 1; 6-2016; 1-101471-24581742-4755CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://reproductive-health-journal.biomedcentral.com/articles/10.1186/s12978-016-0174-4info:eu-repo/semantics/altIdentifier/doi/10.1186/s12978-016-0174-4info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-10-15T14:48:17Zoai:ri.conicet.gov.ar:11336/106839instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-10-15 14:48:17.336CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv The global network antenatal corticosteroids trial: Impact on stillbirth
title The global network antenatal corticosteroids trial: Impact on stillbirth
spellingShingle The global network antenatal corticosteroids trial: Impact on stillbirth
Goldenberg, Robert L.
stillbirth
title_short The global network antenatal corticosteroids trial: Impact on stillbirth
title_full The global network antenatal corticosteroids trial: Impact on stillbirth
title_fullStr The global network antenatal corticosteroids trial: Impact on stillbirth
title_full_unstemmed The global network antenatal corticosteroids trial: Impact on stillbirth
title_sort The global network antenatal corticosteroids trial: Impact on stillbirth
dc.creator.none.fl_str_mv Goldenberg, Robert L.
Thorsten, Vanessa R.
Althabe, Fernando
Saleem, Sarah
Garces, Ana
Carlo, Waldemar A.
Pasha, Omrana
Chomba, Elwyn
Goudar, Shivaprasad
Esamai, Fabian
Krebs, Nancy F.
Derman, Richard J.
Liechty, Edward A.
Patel, Archana
Hibberd, Patricia L.
Buekens, Pierre
Koso-Thomas, Marion
Miodovnik, Menachem
Jobe, Alan H.
Wallace, Dennis D.
Belizan, Jose
McClure, Elizabeth M.
author Goldenberg, Robert L.
author_facet Goldenberg, Robert L.
Thorsten, Vanessa R.
Althabe, Fernando
Saleem, Sarah
Garces, Ana
Carlo, Waldemar A.
Pasha, Omrana
Chomba, Elwyn
Goudar, Shivaprasad
Esamai, Fabian
Krebs, Nancy F.
Derman, Richard J.
Liechty, Edward A.
Patel, Archana
Hibberd, Patricia L.
Buekens, Pierre
Koso-Thomas, Marion
Miodovnik, Menachem
Jobe, Alan H.
Wallace, Dennis D.
Belizan, Jose
McClure, Elizabeth M.
author_role author
author2 Thorsten, Vanessa R.
Althabe, Fernando
Saleem, Sarah
Garces, Ana
Carlo, Waldemar A.
Pasha, Omrana
Chomba, Elwyn
Goudar, Shivaprasad
Esamai, Fabian
Krebs, Nancy F.
Derman, Richard J.
Liechty, Edward A.
Patel, Archana
Hibberd, Patricia L.
Buekens, Pierre
Koso-Thomas, Marion
Miodovnik, Menachem
Jobe, Alan H.
Wallace, Dennis D.
Belizan, Jose
McClure, Elizabeth M.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv stillbirth
topic stillbirth
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.3
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv Background: Antenatal corticosteroids are commonly used to reduce neonatal mortality, but most research to date has been in high-resource settings and few studies have evaluated its impact on stillbirth. In the Antenatal Corticosteroids Trial (ACT), a multi-country trial to assess impact of a multi-faceted intervention including antenatal corticosteroids to reduce neonatal mortality associated with preterm birth, we found an overall increase in 28-day neonatal mortality and stillbirth associated with the intervention.METHODS:The ACT was a cluster-randomized trial conducted in 102 clusters across 7 research sites in 6 countries (India [2 sites], Pakistan, Zambia, Kenya, Guatemala and Argentina), comparing an intervention to train birth attendants at all levels of the health system to identify women at risk of preterm birth, administer corticosteroids and refer women at risk. Because of inadequate gestational age dating, the <5(th) percentile birth weight was used as a proxy for preterm birth. A pre-specified secondary outcome of the trial was stillbirth.RESULTS:After adjusting for the pre-trial imbalance in stillbirth rates, the ACT intervention was associated with a non-significant increased risk of stillbirth (aRR 1.08, 95 % CI, 0.99-1.17, p-0.073). Additionally, the stillbirth rate was higher in the term births (1.20 95 % CI 1.06-1.37, 0.004) and among those with signs of maceration (RR 1.18 (1.04-1.35), p = 0.013) in the intervention vs. control clusters. Differences in obstetric care favored the control clusters and maternal infection was likely more common in the intervention clusters.CONCLUSIONS:In this pragmatic trial, limited data were available to identify the causes of the increase in stillbirths in the intervention clusters. A higher rate of stillbirth in the intervention clusters prior to the trial, differences in obstetric care and an increase in maternal infection are potential explanations for the observed increase in stillbirths in the intervention clusters during the trial.
Fil: Goldenberg, Robert L.. Columbia University; Estados Unidos
Fil: Thorsten, Vanessa R.. RTI International; Estados Unidos
Fil: Althabe, Fernando. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Saleem, Sarah. Columbia University; Estados Unidos. Aga Khan University; Pakistán
Fil: Garces, Ana. No especifíca;
Fil: Carlo, Waldemar A.. University of Alabama at Birmingham; Estados Unidos
Fil: Pasha, Omrana. Aga Khan University; Pakistán
Fil: Chomba, Elwyn. University Teaching Hospital; Zambia
Fil: Goudar, Shivaprasad. KLE University’s; India
Fil: Esamai, Fabian. Moi University; Kenia
Fil: Krebs, Nancy F.. University of Colorado School of Medicine; Estados Unidos
Fil: Derman, Richard J.. Christiana Care Health System; Estados Unidos
Fil: Liechty, Edward A.. Indiana University; Estados Unidos
Fil: Patel, Archana. Lata Medical Research Foundation; India
Fil: Hibberd, Patricia L.. Massachusetts General Hospital; Estados Unidos
Fil: Buekens, Pierre. Tulane School of Public Health and Tropical Medicine; Estados Unidos
Fil: Koso-Thomas, Marion. Eunice Kennedy Shriver National Institute of Child Health and Human Development; Estados Unidos
Fil: Miodovnik, Menachem. Eunice Kennedy Shriver National Institute of Child Health and Human Development; Estados Unidos
Fil: Jobe, Alan H.. Cincinnati Children’s Hospital; Estados Unidos
Fil: Wallace, Dennis D.. RTI International; Estados Unidos
Fil: Belizan, Jose. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: McClure, Elizabeth M.. RTI International; Estados Unidos
description Background: Antenatal corticosteroids are commonly used to reduce neonatal mortality, but most research to date has been in high-resource settings and few studies have evaluated its impact on stillbirth. In the Antenatal Corticosteroids Trial (ACT), a multi-country trial to assess impact of a multi-faceted intervention including antenatal corticosteroids to reduce neonatal mortality associated with preterm birth, we found an overall increase in 28-day neonatal mortality and stillbirth associated with the intervention.METHODS:The ACT was a cluster-randomized trial conducted in 102 clusters across 7 research sites in 6 countries (India [2 sites], Pakistan, Zambia, Kenya, Guatemala and Argentina), comparing an intervention to train birth attendants at all levels of the health system to identify women at risk of preterm birth, administer corticosteroids and refer women at risk. Because of inadequate gestational age dating, the <5(th) percentile birth weight was used as a proxy for preterm birth. A pre-specified secondary outcome of the trial was stillbirth.RESULTS:After adjusting for the pre-trial imbalance in stillbirth rates, the ACT intervention was associated with a non-significant increased risk of stillbirth (aRR 1.08, 95 % CI, 0.99-1.17, p-0.073). Additionally, the stillbirth rate was higher in the term births (1.20 95 % CI 1.06-1.37, 0.004) and among those with signs of maceration (RR 1.18 (1.04-1.35), p = 0.013) in the intervention vs. control clusters. Differences in obstetric care favored the control clusters and maternal infection was likely more common in the intervention clusters.CONCLUSIONS:In this pragmatic trial, limited data were available to identify the causes of the increase in stillbirths in the intervention clusters. A higher rate of stillbirth in the intervention clusters prior to the trial, differences in obstetric care and an increase in maternal infection are potential explanations for the observed increase in stillbirths in the intervention clusters during the trial.
publishDate 2016
dc.date.none.fl_str_mv 2016-06
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/106839
Goldenberg, Robert L.; Thorsten, Vanessa R.; Althabe, Fernando; Saleem, Sarah; Garces, Ana; et al.; The global network antenatal corticosteroids trial: Impact on stillbirth; BioMed Central; Reproductive Health; 13; 1; 6-2016; 1-10
1471-2458
1742-4755
CONICET Digital
CONICET
url http://hdl.handle.net/11336/106839
identifier_str_mv Goldenberg, Robert L.; Thorsten, Vanessa R.; Althabe, Fernando; Saleem, Sarah; Garces, Ana; et al.; The global network antenatal corticosteroids trial: Impact on stillbirth; BioMed Central; Reproductive Health; 13; 1; 6-2016; 1-10
1471-2458
1742-4755
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/url/https://reproductive-health-journal.biomedcentral.com/articles/10.1186/s12978-016-0174-4
info:eu-repo/semantics/altIdentifier/doi/10.1186/s12978-016-0174-4
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
application/pdf
dc.publisher.none.fl_str_mv BioMed Central
publisher.none.fl_str_mv BioMed Central
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
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reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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