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

NCT04958304 | Terminated DMC

• 1 other identifier: mRNA-1273-P902
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SARS-CoV-2

Keywords

mRNA-1273; mRNA-1273 vaccine; SARS-CoV-2; SARS-CoV-2 Vaccine; Coronavirus; Virus Diseases; Messenger RNA; COVID-19; COVID-19 Vaccine; Moderna

Outcome Measures

Primary Outcomes (4)

• 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

• 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)

• 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)

• 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

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who have been exposed the Moderna COVID-19 vaccine during the 28 days prior to their LMP or at any time during pregnancy are eligible for this exposed cohort.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (1)

IQVIA Call Center for United States and Canada

Durham, North Carolina, 27703, United States

Location

MeSH Terms

Conditions

Coronavirus Infections; Virus Diseases; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 21 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 12, 2021
• Study Start: September 1, 2021
• Primary Completion: September 22, 2023
• Study Completion: September 22, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

US (1)