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

January 22, 2024 updated by: University of California, San Francisco

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.

Study Overview

Status

Active, not recruiting

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.

Study Type

Observational

Enrollment (Actual)

7965

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Francisco, California, United States, 94158
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Male (biologically unable to achieve pregnancy)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 9 months
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.
Up to 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
Up to 1.5 years
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.
Up to 27 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Heather Huddleston, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2020

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 7, 2020

First Submitted That Met QC Criteria

May 12, 2020

First Posted (Actual)

May 14, 2020

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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