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

Pregnancy Related Clinical Trial

— ASPIRE  

Official title:

Assessing the Safety of Pregnancy In the CoRonavirus pandEmic: a Nationwide Prospective Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04388605
• Other study ID #: 20-30559
• Status: Active, not recruiting
• Start date: April 21, 2020
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7965
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over age 18

• Participant is 4-10 weeks pregnant (gestation)

Exclusion Criteria:

• Male (biologically unable to achieve pregnancy)

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID
• Early Pregnancy
• Pregnancy Related

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 9 months
Primary	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.	Up to 9 months
Secondary	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.	Up to 9 months
Secondary	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.	Up to 1.5 years
Secondary	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.	Up to 27 months