Clinical trial NCT04388605: Assessing the Safety of Pregnancy In the CoRonavirus (COVID-19) pandEmic
Official title: Assessing the Safety of Pregnancy In the CoRonavirus pandEmic: a Nationwide Prospective Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Corona Virus Infection
COVID
Pregnancy Related
Early Pregnancy
Keywords: COVID-19
Pregnancy
Coronavirus
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-05-14
Enrollment: 7965
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators are recruiting 10,000 women from the start of pregnancy (4-10 weeks gestation) 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.

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.

Eligibility criteria: Inclusion Criteria:

* Over age 18
* Participant is 4-10 weeks pregnant (gestation)

Exclusion Criteria:

- Male (biologically unable to achieve pregnancy)

Primary outcomes:
measure: Prevalence of SARS-CoV-2 infection throughout pregnancy in women
timeFrame: Up to 9 months
measure: Incidence of SARS-CoV-2 infection throughout pregnancy in women
timeFrame: Up to 9 months
Secondary outcomes:
measure: Risk ratios of adverse obstetric in women infect with SARS-CoV-2 during early pregnancy onward compared to non-infected pregnant women
timeFrame: Up to 9 months
measure: Risk ratios of adverse neonatal outcomes in women infected with SARS-CoV-2 during early pregnancy onward compared to non-infected pregnant women
timeFrame: Up to 1.5 years
measure: Clinical, behavioral, and sociodemographic determinants
timeFrame: Up to 27 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Heather Huddleston, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.