Assessing the Safety of Pregnancy In the CoRonavirus (COVID-19) pandEmic
NCT ID: NCT04388605
Last Updated: 2025-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
7965 participants
OBSERVATIONAL
2020-04-21
2026-12-31
Brief Summary
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Detailed Description
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Currently, there are no data about the effects of COVID-19 infections in the first trimester. The study will provide critical information to:
1. Guide the care of pregnant women
2. Protect the safety of their babies and families
3. Help those considering pregnancy in the future understand what it means to be pregnant in this new era
The investigators are recruiting 10,000 women from the start of pregnancy and will track COVID-19 exposures using frequent serology testing. The investigators will collect information during and after the pregnancy to try to determine the effects of COVID 19 for mom and baby.
Participants will be asked to do the following throughout pregnancy:
* Submit frequent, quick (\<1 minute each) symptom tracking reports using your mobile phone and/or computer.
* Collect finger-stick blood samples from home at several points throughout your pregnancy.
* Give permission to review medical records related to your pregnancy, delivery and baby's development.
* Complete questionnaires online about your health during your pregnancy and after delivery of your baby.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Participant is 4-10 weeks pregnant (gestation)
Exclusion Criteria
18 Years
FEMALE
Yes
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Heather Huddleston, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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References
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Huddleston HG, Jaswa EG, Lindquist KJ, Kaing A, Morris JR, Hariton E, Corley J, Hoskin E, Gaw SL, Cedars MI. COVID-19 vaccination patterns and attitudes among American pregnant individuals. Am J Obstet Gynecol MFM. 2022 Jan;4(1):100507. doi: 10.1016/j.ajogmf.2021.100507. Epub 2021 Oct 11. No abstract available.
Other Identifiers
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20-30559
Identifier Type: -
Identifier Source: org_study_id
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