Corona Virus InfectionASPIRENCT04388605
Assessing the Safety of Pregnancy In the CoRonavirus (COVID-19) pandEmic
An observational study of Corona Virus Infection and COVID, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Corona Virus Infection, COVID, Pregnancy Related
- How many people
- 7,965 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2020to Dec 2026
- How long will I take part?
- 20 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Over age 18
- Participant is 4-10 weeks pregnant (gestation)
Who cannot join
- Male (biologically unable to achieve pregnancy)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94158
About this study
Official title: Assessing the Safety of Pregnancy In the CoRonavirus pandEmic: a Nationwide Prospective Study
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.
Read the 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:
- Guide the care of pregnant women
- Protect the safety of their babies and families
- 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
- Corona Virus Infection, COVID, Pregnancy Related, Early Pregnancy
- Keywords
- COVID-19, Pregnancy, Coronavirus
- Medical subject headings
- Coronavirus Infections, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of SARS-CoV-2 infection throughout pregnancy in women
Determine the prevalence of SARS-CoV-2 infection throughout pregnancy in women whose pregnancy was documented at a SART member clinic in the United States between November 2019-December 2020. The investigators will use patient-reported information on infection symptoms as well as serological testing to capture both symptomatic and asymptomatic infections. Deliverable: By instituting the first prospectively tracked U.S.-based pregnancy cohort with precisely timed conception, the investigators will provide foundational, urgent data regarding the epidemiology of SARS-CoV-2 infection at varying gestational ages, across the real-time evolution of the COVID-19 pandemic and in the setting of various public health measures to reduce infection spread.
Measured: Up to 9 months
Incidence of SARS-CoV-2 infection throughout pregnancy in women
Determine the incidence of SARS-CoV-2 infection throughout pregnancy in women whose pregnancy was documented at a SART member clinic in the United States between November 2019-December 2020. The investigators will use patient-reported information on infection symptoms as well as serological testing to capture both symptomatic and asymptomatic infections. Deliverable: By instituting the first prospectively tracked U.S.-based pregnancy cohort with precisely timed conception, the investigators will provide foundational, urgent data regarding the epidemiology of SARS-CoV-2 infection at varying gestational ages, across the real-time evolution of the COVID-19 pandemic and in the setting of various public health measures to reduce infection spread.
Measured: Up to 9 months
Secondary outcomes (3)
Risk ratios of adverse obstetric in women infect with SARS-CoV-2 during early pregnancy onward compared to non-infected pregnant women
Determine risk ratios of adverse obstetric outcomes in women infected with SARS-CoV-2 during early pregnancy onward compared to non-infected pregnant women. The investigators will focus on timing of infection (gestational month) and extent of COVID-19 symptoms as potential predictors of risk. Deliverable: The investigators will provide critical information about the maternal and fetal implications of SARS-CoV-2 infection at specific time points in pregnancy, compared to non-exposed pregnancies, and enable evidence-based obstetric surveillance protocols.
Measured: Up to 9 months
Risk ratios of adverse neonatal outcomes in women infected with SARS-CoV-2 during early pregnancy onward compared to non-infected pregnant women
Determine risk ratios of adverse neonatal outcomes in women infected with SARS-CoV-2 during early pregnancy onward compared to non-infected pregnant women. The investigators will focus on timing of infection (gestational month) and extent of COVID-19 symptoms as potential predictors of risk. Deliverable: The investigators will provide critical information about the maternal and fetal implications of SARS-CoV-2 infection at specific time points in pregnancy, compared to non-exposed pregnancies, and enable evidence-based obstetric surveillance protocols.
Measured: Up to 1.5 years
Clinical, behavioral, and sociodemographic determinants
Identify clinical, behavioral and sociodemographic determinants that predict risk of (a) maternal infection during pregnancy and (b) severe infection symptomatology (hospitalization, ICU admission). Deliverable: The investigators will provide novel findings that identify high-risk groups warranting more aggressive social avoidance measures during pregnancy.
Measured: Up to 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start21 Apr 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,965 participants (actual)
- Target duration
- 20 Months
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Huddleston, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388605
- Sponsor's protocol ID
- 20-30559
- Acronym
- ASPIRE
- Status last verified
- Aug 2026
- First submitted
- 7 May 2020
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 34649015
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Safety of Pregnancy In the CoRonavirus pandEmic: a Nationwide Prospective Study
- ClinicalTrials.gov ID
- NCT04388605
- Acronym / sponsor ID
- ASPIRE / 20-30559
- Conditions
- Corona Virus Infection, COVID, Pregnancy Related, Early Pregnancy
- Keywords
- COVID-19, Pregnancy, Coronavirus
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 7,965 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 21 Apr 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Guide the care of pregnant women
- Protect the safety of their babies and families
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Over age 18
- Participant is 4-10 weeks pregnant (gestation)
Key exclusion criteria (1 listed)
- Male (biologically unable to achieve pregnancy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of SARS-CoV-2 infection throughout pregnancy in women
Time frame: Up to 9 months
Determine the prevalence of SARS-CoV-2 infection throughout pregnancy in women whose pregnancy was documented at a SART member clinic in the United States between November 2019-December 2020. The investigators will use patient-reported information on infection symptoms as well as serological testing to capture both symptomatic and asymptomatic infections. Deliverable: By instituting the first prospectively tracked U.S.-based pregnancy cohort with precisely timed conception, the investigators will provide foundational, urgent data regarding the epidemiology of SARS-CoV-2 infection at varying gestational ages, across the real-time evolution of the COVID-19 pandemic and in the setting of various public health measures to reduce infection spread.
Incidence of SARS-CoV-2 infection throughout pregnancy in women
Time frame: Up to 9 months
Determine the incidence of SARS-CoV-2 infection throughout pregnancy in women whose pregnancy was documented at a SART member clinic in the United States between November 2019-December 2020. The investigators will use patient-reported information on infection symptoms as well as serological testing to capture both symptomatic and asymptomatic infections. Deliverable: By instituting the first prospectively tracked U.S.-based pregnancy cohort with precisely timed conception, the investigators will provide foundational, urgent data regarding the epidemiology of SARS-CoV-2 infection at varying gestational ages, across the real-time evolution of the COVID-19 pandemic and in the setting of various public health measures to reduce infection spread.
3 secondary outcomes
Risk ratios of adverse obstetric in women infect with SARS-CoV-2 during early pregnancy onward compared to non-infected pregnant women
Time frame: Up to 9 months
Risk ratios of adverse neonatal outcomes in women infected with SARS-CoV-2 during early pregnancy onward compared to non-infected pregnant women
Time frame: Up to 1.5 years
Clinical, behavioral, and sociodemographic determinants
Time frame: Up to 27 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Derived from this study: PubMed 34649015Huddleston 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Huddleston, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corona Virus Infection and COVID, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of SARS-CoV-2 infection throughout pregnancy in women (time frame: Up to 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04388605, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.