Description of maternal and neonatal adverse events in pregnant people immunised with COVID-19 vaccines during pregnancy in the CLAP NETWORK of sentinel sites. Nested case–control analysis of the immunization-associated risk: A study protocol.
Fil: Macías Saint-Gerons, D. Department of Medicine, University of Valencia, INCLIVA Health Research Institute and CIBERSAM, Valencia; Spain
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2024
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| Acceso en línea: | http://repositorio.cedes.org/handle/123456789/4765 https://doi.org/10.1136/bmjopen-2023-073095 |
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I61-R167-123456789-47652025-04-12T15:45:47Z Description of maternal and neonatal adverse events in pregnant people immunised with COVID-19 vaccines during pregnancy in the CLAP NETWORK of sentinel sites. Nested case–control analysis of the immunization-associated risk: A study protocol. Macías Saint-Gerons, Diego Castro, José Luis Colomar, Mercedes Rojas, Edgar Sosa, Claudio Ropero, Alba Maria Serruya, Suzanne Jacob Pastor, Desiré Chiu, Monica Velandia-Gonzalez, Martha Ábalos, Edgardo Durán, Pablo Gomez Ponce de León, Rodolfo Tomasso, Giselle Mainero, Luis Rubino, Marcelo De Mucio, Bremen Pregnancy COVID-19 Fil: Macías Saint-Gerons, D. Department of Medicine, University of Valencia, INCLIVA Health Research Institute and CIBERSAM, Valencia; Spain Introduction COVID-19 is associated with higher morbimortality in pregnant people compared with non-pregnant people. At present, the benefits of maternal immunisation are considered to outweigh the risks, and therefore, vaccination is recommended during pregnancy. However, additional information is needed on the safety of the vaccines in this population. Methods and analysis This a retrospective cohort nested case–control study in pregnant people who attended maternity hospitals from eight Latin American and Caribbean countries. A perinatal electronic clinical history database with neonatal and obstetric information will be used. The proportion of pregnant people immunised with COVID-19 vaccines of the following maternal and neonatal events will be described: preterm infant, small for gestational age, low birth weight, stillbirth, neonatal death, congenital malformations, maternal near miss and maternal death. Moreover, the risk of prematurity, small for gestational age and low birth weight associated with exposure to COVID-19 vaccines will be estimated. Each case will be matched with two groups of three randomly selected controls. Controls will be matched by hospital and mother’s age (±3 years) with an additional matching by delivery date and conception time in the first and second control groups, respectively. The estimated required sample size for the main analysis (exposure to any vaccine) concerning ‘non-use’ is at least 1009 cases (3027 controls) to detect an increased probability of vaccine-associated event risk of 30% and at least 650 cases (1950 controls) to detect 30% protection. Sensitivity and secondary analyses considering country, type of vaccine, exposure windows and completeness of immunisation will be reported. Ethics The study protocol was reviewed by the Ethical Review Committee on Research of the Pan American Health Organization. Patient informed consent was waived due to the retrospective design and the utilisation of anonymised data (Ref. No: PAHOERC.0546.01). Results will be disseminated in open access journals. https://creativecommons.org/licenses/by/3.0/igo/ This is an open access article distributed under the terms of the Creative Commons Attribution IGO License (CC BY 3.0 IGO), which permits use, distribution,and reproduction in any medium, provided the original work is properly cited. In any reproduction of this article there should not be any suggestion that WHO or this article endorse any specific organization or products. The use of the WHO logo is not permitted. This notice should be preserved along with the article’s original URL. 2024-02-06T19:56:16Z 2024-02-06T19:56:16Z 2024-01 Artículo Macías Saint-Gerons D, Castro JL, Colomar M, et al. Description of maternal and neonatal adverse events in pregnant people immunised with COVID-19 vaccines during pregnancy in the CLAP NETWORK of sentinel sites. Nested case–control analysis of the immunization-associated risk: A study protocol.. BMJ Open 2024;14:e073095. doi:10.1136/ bmjopen-2023-073095 http://repositorio.cedes.org/handle/123456789/4765 https://doi.org/10.1136/bmjopen-2023-073095 en BMJ Open;2024;14:e073095 application/pdf |
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Centro de Estudios de Estado y Sociedad (CEDES) |
| institution_str |
I-61 |
| repository_str |
R-167 |
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Respositorio Digital CRIS del CEDES - Centro de Estudios de Estado y Sociedad |
| language |
Inglés |
| topic |
Pregnancy COVID-19 |
| spellingShingle |
Pregnancy COVID-19 Macías Saint-Gerons, Diego Castro, José Luis Colomar, Mercedes Rojas, Edgar Sosa, Claudio Ropero, Alba Maria Serruya, Suzanne Jacob Pastor, Desiré Chiu, Monica Velandia-Gonzalez, Martha Ábalos, Edgardo Durán, Pablo Gomez Ponce de León, Rodolfo Tomasso, Giselle Mainero, Luis Rubino, Marcelo De Mucio, Bremen Description of maternal and neonatal adverse events in pregnant people immunised with COVID-19 vaccines during pregnancy in the CLAP NETWORK of sentinel sites. Nested case–control analysis of the immunization-associated risk: A study protocol. |
| topic_facet |
Pregnancy COVID-19 |
| description |
Fil: Macías Saint-Gerons, D. Department of Medicine, University of Valencia, INCLIVA Health Research Institute and CIBERSAM, Valencia; Spain |
| format |
Artículo |
| author |
Macías Saint-Gerons, Diego Castro, José Luis Colomar, Mercedes Rojas, Edgar Sosa, Claudio Ropero, Alba Maria Serruya, Suzanne Jacob Pastor, Desiré Chiu, Monica Velandia-Gonzalez, Martha Ábalos, Edgardo Durán, Pablo Gomez Ponce de León, Rodolfo Tomasso, Giselle Mainero, Luis Rubino, Marcelo De Mucio, Bremen |
| author_facet |
Macías Saint-Gerons, Diego Castro, José Luis Colomar, Mercedes Rojas, Edgar Sosa, Claudio Ropero, Alba Maria Serruya, Suzanne Jacob Pastor, Desiré Chiu, Monica Velandia-Gonzalez, Martha Ábalos, Edgardo Durán, Pablo Gomez Ponce de León, Rodolfo Tomasso, Giselle Mainero, Luis Rubino, Marcelo De Mucio, Bremen |
| author_sort |
Macías Saint-Gerons, Diego |
| title |
Description of maternal and neonatal adverse events in pregnant people immunised with COVID-19 vaccines during pregnancy in the CLAP NETWORK of sentinel sites. Nested case–control analysis of the immunization-associated risk: A study protocol. |
| title_short |
Description of maternal and neonatal adverse events in pregnant people immunised with COVID-19 vaccines during pregnancy in the CLAP NETWORK of sentinel sites. Nested case–control analysis of the immunization-associated risk: A study protocol. |
| title_full |
Description of maternal and neonatal adverse events in pregnant people immunised with COVID-19 vaccines during pregnancy in the CLAP NETWORK of sentinel sites. Nested case–control analysis of the immunization-associated risk: A study protocol. |
| title_fullStr |
Description of maternal and neonatal adverse events in pregnant people immunised with COVID-19 vaccines during pregnancy in the CLAP NETWORK of sentinel sites. Nested case–control analysis of the immunization-associated risk: A study protocol. |
| title_full_unstemmed |
Description of maternal and neonatal adverse events in pregnant people immunised with COVID-19 vaccines during pregnancy in the CLAP NETWORK of sentinel sites. Nested case–control analysis of the immunization-associated risk: A study protocol. |
| title_sort |
description of maternal and neonatal adverse events in pregnant people immunised with covid-19 vaccines during pregnancy in the clap network of sentinel sites. nested case–control analysis of the immunization-associated risk: a study protocol. |
| publishDate |
2024 |
| url |
http://repositorio.cedes.org/handle/123456789/4765 https://doi.org/10.1136/bmjopen-2023-073095 |
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