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

NCT04388605 | Active Not Recruiting

• 1 other identifier: 20-30559
• Study Type: observational
• Target: 7,965
• Locations: 1 country
• Sites: 1

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.

Conditions

Corona Virus Infection; COVID; Pregnancy Related; Early Pregnancy

Keywords

COVID-19; Pregnancy; Coronavirus

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Risk ratios of adverse obstetric in women infect with SARS-CoV-2 during early pregnancy onward compared to non-infected pregnant women

  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

  Up to 1.5 years

• Clinical, behavioral, and sociodemographic determinants

  Up to 27 months

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \- Male (biologically unable to achieve pregnancy)

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

Related Publications (1)

• 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.

  PMID: 34649015 DERIVED

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.

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Heather Huddleston, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 14, 2020
• Study Start: April 21, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)