Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-01-02 @ 7:34 AM
Study NCT ID:
NCT04388605
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-08
First Post:
2020-05-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Safety of Pregnancy In the CoRonavirus (COVID-19) pandEmic
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Assessing the Safety of Pregnancy In the CoRonavirus pandEmic: a Nationwide Prospective Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASPIRE
Brief Summary:
Prospective nationwide cohort study of pregnant women enrolled early in gestation and followed for Covid-19 exposure and infection, with follow up of obstetrical outcomes and infant development through the first year of life.
Detailed Description:
ASPIRE is focused on the first trimester, a critical and vulnerable period when all of a baby's organ systems form and the placenta - the crucial connection between mom and baby - develops.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: