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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04958304
Other study ID # mRNA-1273-P902
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date September 22, 2023

Study information

Verified date November 2023
Source ModernaTX, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date September 22, 2023
Est. primary completion date September 22, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
United States IQVIA Call Center for United States and Canada Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Having Infants With Suspected Major and Minor Congenital Malformations Major malformations are those that have significant medical, social or cosmetic consequences, and typically require surgical intervention or are life-threatening (for example, cleft lip, spina bifida). Up to 1 year of infant age
Primary Number of Participants With Any Pregnancy Complications Pregnancy complications may include preeclampsia, eclampsia, pregnancy-induced hypertension, antenatal bleeding, preterm labor, gestational diabetes, dysfunctional labor, premature rupture of membranes, placenta previa, postpartum hemorrhage, small-for-gestational-age (SGA) fetus and intrauterine growth restriction (IUGR), and non-reassuring fetal status. From end of first trimester (approximately 14 weeks) up to mid-third trimester (approximately 34 weeks)
Primary Number of Participants With Any Pregnancy Outcomes Pregnancy outcomes may include spontaneous abortions, fetal death or stillbirth, live birth, elective or therapeutic pregnancy terminations, preterm birth, ectopic pregnancies, molar pregnancies, maternal death, and COVID-19 diagnosis. Approximately 4 weeks after expected date of delivery (EDD)
Primary Number of Participants With Infant Outcomes Infant outcomes may include minor congenital malformations, size of gestational age, low birth weight, size for age, failure to thrive, hospitalization of infants, neonatal death, perinatal death, neonatal encephalopathy, respiratory distress in the newborn, neonatal/infant infection, infant death, and infant developmental milestones. Up to 1 year of infant age
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