ACTIVE_NOT_RECRUITING

Project HOPE 1000: Health Outcomes Pregnancy Exposures

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to collect biological samples from pregnant women and their babies and to collect data on long-term health, school outcomes, and the use of state and county services. The information learned from this study may help identify important factors that may influence the health of mothers and babies, both short-and long-term.

Official Title

Project HOPE 1000: A Longitudinal Study of Mothers and Infants to Understand Health Outcomes Related to Pregnancy and Early-Life Exposures

Quick Facts

Study Start:2018-11-21
Study Completion:2027-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04417283

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * The subject has provided a signed Informed consent prior to any study procedures.
  2. * Maternal age at consent of ≥ 18 years old
  3. * Ability to understand English or Spanish
  4. * Willingness to comply with and be available for all protocol procedures
  5. * Singleton gestation \< 24 weeks 0 days
  6. * Receiving prenatal care at a Duke-affiliated Obstetrics clinic with the intent of delivering at Duke University Health System-affiliated hospital (including Duke University Hospital and Duke Regional Hospital)
  7. * Plans to have their infant seen at a Duke-affiliated Pediatrics practice after birth
  8. * Plans to remain in the area for two years after delivery
  1. * Non-viable pregnancy
  2. * Having any condition that, in the opinion of the site investigators, would place the subject at unacceptable risk of injury or confound data interpretation

Contacts and Locations

Principal Investigator

Jennifer Gilner, MD
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

Duke affiliated ObGyn clinics within Duke Health
Durham, North Carolina, 27710
United States

Collaborators and Investigators

Sponsor: Duke University

  • Jennifer Gilner, MD, PRINCIPAL_INVESTIGATOR, Duke University

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 Registration Dates

Study Start Date2018-11-21
Study Completion Date2027-03-01

Study Record Updates

Study Start Date2018-11-21
Study Completion Date2027-03-01

Terms related to this study

Keywords Provided by Researchers

  • Pregnancy
  • Gestation
  • Placenta
  • Exposure
  • Environment
  • Social Drivers of Health
  • Infancy
  • Biological specimens
  • Electronic health records

Additional Relevant MeSH Terms

  • Pregnant