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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04958304
Recruitment Status : Terminated (Study has been terminated and replaced due to low enrollment.)
First Posted : July 12, 2021
Last Update Posted : November 28, 2023
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Study Description
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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.

Condition or disease
SARS-CoV-2

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.
Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 21 Months
Official Title: Moderna mRNA-1273 Observational Pregnancy Outcome Study
Actual Study Start Date : September 1, 2021
Actual Primary Completion Date : September 22, 2023
Actual Study Completion Date : September 22, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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).


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Having Infants With Suspected Major and Minor Congenital Malformations [ Time Frame: Up to 1 year of infant age ]
    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).

  2. Number of Participants With Any Pregnancy Complications [ Time Frame: From end of first trimester (approximately 14 weeks) up to mid-third trimester (approximately 34 weeks) ]
    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.

  3. Number of Participants With Any Pregnancy Outcomes [ Time Frame: Approximately 4 weeks after expected date of delivery (EDD) ]
    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.

  4. Number of Participants With Infant Outcomes [ Time Frame: Up to 1 year of infant age ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04958304


Locations
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United States, North Carolina
IQVIA Call Center for United States and Canada
Durham, North Carolina, United States, 27703
Sponsors and Collaborators
ModernaTX, Inc.
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT04958304    
Other Study ID Numbers: mRNA-1273-P902
First Posted: July 12, 2021    Key Record Dates
Last Update Posted: November 28, 2023
Last Verified: November 2023
Keywords provided by ModernaTX, Inc.:
mRNA-1273
mRNA-1273 vaccine
SARS-CoV-2
SARS-CoV-2 Vaccine
Coronavirus
 Virus Diseases
Messenger RNA
COVID-19
COVID-19 Vaccine
Moderna