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Assessing the Safety of Pregnancy In the CoRonavirus (COVID-19) pandEmic (ASPIRE)

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ClinicalTrials.gov Identifier: NCT04388605
Recruitment Status : Recruiting
First Posted : May 14, 2020
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease
Corona Virus Infection COVID Pregnancy Related Early Pregnancy

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 11000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 20 Months
Official Title: Assessing the Safety of Pregnancy In the CoRonavirus pandEmic: a Nationwide Prospective Study
Actual Study Start Date : April 21, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.

  3. Clinical, behavioral, and sociodemographic determinants [ Time Frame: Up to 27 months ]
    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.


Biospecimen Retention:   Samples Without DNA
At-home blood spot kits will be used for serology surveillance. Tests will occur weekly during the first trimester and monthly during the second and third trimesters of pregnancy. Covid-19 antibody serology and cytokine testing will be assayed using these blood spot cars.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Male (biologically unable to achieve pregnancy)


Information from the National Library of Medicine

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): NCT04388605


Contacts
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Contact: Heather Huddleston, MD 415-353-3040 heather.huddleston@ucsf.edu
Contact: Eleni Jaswa, MD, MSc Eleni.Jaswa@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Heather Huddleston    415-353-3040    heather.huddleston@ucsf.edu   
Contact       ASPIRE@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Heather Huddleston, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04388605    
Other Study ID Numbers: 20-30559
First Posted: May 14, 2020    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
COVID-19
Pregnancy
Coronavirus
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases