Clinical Trial Protocol Journal Article Research Support, Non-U.S. Gov't Epublish 1 citation
PubMed: 38286697 DOI: 10.1136/bmjopen-2023-073095
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 14(1):e073095
Authors: Diego Macías Saint-Gerons, José Luis Castro, Mercedes Colomar, Edgard Rojas, Claudio Sosa, Alba Maria Ropero, Suzanne Jacob Serruya, Desiré Pastor, Monica Chiu, Martha Velandia-Gonzalez, Edgardo Abalos, Pablo Durán, Rodolfo Gomez Ponce de León, Giselle Tomasso, Luis Mainero, Marcelo Rubino, Bremen De Mucio
Affiliations
- Department of Medicine, University of Valencia, INCLIVA Health Research Institute and CIBERSAM, Valencia, Spain.
- Fundación para la innovación, la formación, la investigación y el desarrollo comunitario (FUNDEC), Santa Cruz de Tenerife, Spain.
- Unidad de Investigación Clínica y Epidemiológica Montevideo, Montevideo, Uruguay. Deparment of Preventive and Social Medicine, School of Medicine, Montevideo, Uruguay.
- Innovation, Access to Medicines and Health Technologies (IMT), PAHO, Washington, District of Columbia, USA.
- Department of Obstetrics and Gynecology, Pereira Rossell Hospital, School of Medicine, Universidad de la Republica Uruguay, Montevideo, Uruguay.
- PAHO, Washington, District of Columbia, USA.
- Latin American Center of Perinatology, Women and Reproductive Health (CLAP/WR), PAHO, Montevideo, Uruguay.
- Centro de Estudios de Estado y Sociedad (CEDES), Buenos Aires, Argentina.
- Unidad de Investigación Clínica y Epidemiológica Montevideo, Montevideo, Uruguay.
Abstract
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.
MeSH
Pregnancy, Immunization, Parturition, Vaccines, Covid-19 Vaccines, Gestational Age, Drug-Related Side Effects And Adverse Reactions, Covid-19, Birth Weight, Perinatology