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

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ClinicalTrials.gov Identifier: NCT04958304
Recruitment Status : Recruiting
First Posted : July 12, 2021
Last Update Posted : December 21, 2021
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 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
Estimated Primary Completion Date : December 9, 2023
Estimated Study Completion Date : January 6, 2024

Resource links provided by the National Library of Medicine


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).



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.



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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.

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


Contacts
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Contact: Moderna Clinical Trials Support Center 1-877-777-7187 clinicaltrials@modernatx.com

Locations
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United States, North Carolina
IQVIA Call Center for United States and Canada Recruiting
Durham, North Carolina, United States, 27703
Sponsors and Collaborators
ModernaTX, Inc.
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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: December 21, 2021
Last Verified: December 2021
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
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases