This study is in progress, not accepting new patients

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

a study on COVID-19 Pregnancy

Summary

Eligibility
for females ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Heather Huddleston, MD
Headshot of Heather Huddleston
Heather Huddleston

Description

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.

Official Title

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

Details

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.

Keywords

Corona Virus Infection, COVID, Pregnancy Related, Early Pregnancy, COVID-19, Pregnancy, Coronavirus, Coronavirus Infections

Eligibility

You can join if…

Open to females ages 18 years and up

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

You CAN'T join if...

  • Male (biologically unable to achieve pregnancy)

Location

  • UCSF
    San Francisco California 94158 United States

Lead Scientist at UCSF

  • Heather Huddleston, MD
    Dr. Heather Huddleston is a specialist in reproductive endocrinology (hormonal function) and infertility. She cares for patients with a wide array of reproductive and fertility concerns. She has special interests in polycystic ovary syndrome (PCOS), recurrent pregnancy loss and uterine disorders, including Asherman's syndrome (a condition involving scar tissue in the uterus).

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04388605
Study Type
Observational [Patient Registry]
Participants
About 7965 people participating
Last Updated