Moderna COVID-19 Vaccine mRNA-1273 Observational Pregnancy Outcome Study
Purpose
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.
Condition
- SARS-CoV-2
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Moderna COVID-19 Vaccine in Pregnant Women | 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). |
Recruiting Locations
More Details
- NCT ID
- NCT04958304
- Status
- Terminated
- Sponsor
- ModernaTX, Inc.
Detailed 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.