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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Moderna mRNA-1273 Observational Pregnancy Outcome Study

Conditions
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SARS-CoV-2

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Moderna COVID-19 Vaccine in Pregnant Women<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mRNA-1273, mRNA-1273 vaccine, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Virus Diseases, Messenger RNA, COVID-19, COVID-19 Vaccine, Moderna