Moderna COVID-19 Vaccine mRNA-1273 Observational Pregnancy Outcome Study

Moderna

Status: Terminated

Conditions: SARS-CoV-2

Study type: Observational

Funder types: Industry

Identifiers

NCT04958304

mRNA-1273-P902

Details and patient eligibility

About

The main goal of this study is to evaluate the outcomes of pregnancy in females exposed to the Moderna COVID-19 vaccine (mRNA-1273) during pregnancy.

Full description

The Moderna COVID-19 Vaccine Pregnancy Registry will collect and analyze information on the potential impact of exposure to the Moderna COVID-19 vaccine on pregnancy and birth outcomes.

Enrollment: 20 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Currently pregnant
• The outcome of pregnancy (that is, pregnancy loss or live birth) must not be known at entry.
• Agrees to electronically sign the release of medical information form permitting the study to contact her HCPs (for example, primary care provider [PCP], obstetrician, nurse midwife) and the infant's HCP (for example, pediatrician) for medical information.
• Received the Moderna COVID-19 vaccine at any point from 28 days prior to last menstrual period (LMP) throughout pregnancy.

Exclusion criteria

• Participant has received any other COVID-19 vaccines at any point from 28 days prior to LMP throughout pregnancy.
• Women currently participating in another investigational device or drug study, currently taking an investigational medicinal product, or having taken an investigational product within 28 days prior to LMP or during pregnancy.

Trial design

20 participants in 1 patient group

Moderna COVID-19 Vaccine in Pregnant Women

Description:

The Moderna COVID-19 Vaccine Pregnancy Registry will collect primary data from pregnant women who have received the Moderna COVID-19 vaccine and their healthcare providers (HCPs).