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Enrolling by invitation NCT07216287

Sleep Health in Pregnant Women in ENRICH

— Observational Pregnancy Sleep

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No Intervention: Observational Cohort.
Who it may be relevant to
Registry conditions: Pregnancy, Sleep. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Enhancing Cardiovascular Health in Mothers and Children Through Home Visiting (Supplement)

Overview

This proposal will study sleep health in pregnant women who are of low socioeconomic status (SES) and are participating in the NHLBI-funded UH3 grant: "Enhancing Cardiovascular (CV) Health in Mothers and Children Through Home Visiting (ENRICH)". Objective sleep health will be measured using an in-home sleep disordered breathing testing device and actigraphy and associations of sleep health with social determinants of health and CV health will be investigated. Data from this study will serve as the foundation for future work that will result in the development of sleep interventions and updated guidelines for screening and treatment of sleep in pregnancy.

Interventions

  • Other No Intervention: Observational Cohort
    No intervention, observational cohort study

Primary outcome measures

  • Sleep Health [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • Currently enrolled in a HV agency participating in ENRICH
  • Pregnant, with a single or multiple pregnancy, at or less than 34 weeks 0 days gestation
  • 18 years of age or older
  • low SES (Medicaid eligibility or income at or below the federal poverty line) and/or African American Race and/or Hispanic/Latino ethnicity

Exclusion criteria

  • None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Washington University in St. Louis — St Louis

Identifiers

NCT: NCT07216287 · 202508143 · UH3HL162970

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗