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Título:

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

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Macías Saint-Gerons, Diego
Castro, José Luis
Colomar, Mercedes
Rojas, Edgard
Sosa, Claudio
Ropero, Alba María
Jacob Serruya, Suzanne
Pastor, Desiré
Chiu, Mónica
Velandia-Gonzalez, Martha
Abalos, Edgardo
Durán, Pablo
Gomez Ponce de León, Rodolfo
Tomasso, Giselle
Mainero, Luis
Rubino, Marcelo
De Mucio, Bremen

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Palabras clave:

COVID-19
Maternal medicine
Perinatology

Descriptores:

VACUNAS CONTRA LA COVID-19
PERINATOLOGÍA
EFECTOS ADVERSOS A LARGO PLAZO
EPIDEMIOLOGÍA
PREVENCIÓN DE ENFERMEDADES
ESTUDIOS DE CASOS Y CONTROLES
MUJERES
EMBARAZO
ENSAYOS CLÍNICOS COMO ASUNTO
RETARDO DEL CRECIMIENTO FETAL
INMUNIZACIÓN
VACUNACIÓN
RECIÉN NACIDO
RECIÉN NACIDO PREMATURO
ESTUDIOS RETROSPECTIVOS
MORTINATO
VACUNAS

Año de publicación:

2024

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Resumen:

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.

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BMJ Publishing Group

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BMJ Open. 2024;14(1)

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Citación:

Macías Saint-Gerons D, Castro J, Colomar M y otros. 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 [en línea]. 2024;14(1). 10 p.

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https://hdl.handle.net/20.500.12008/56078

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Licencia Creative Commons Atribución (CC - By 4.0)

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