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
|Condition or disease|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|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|
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).
- 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).
- 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.
- 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.
- 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.
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
|Contact: Moderna Clinical Trials Support Centeremail@example.com|
|United States, North Carolina|
|IQVIA Call Center for United States and Canada||Recruiting|
|Durham, North Carolina, United States, 27703|