Trials / Recruiting

RecruitingNCT05492708

The Heartland Study

Children's Health in the Heartland Study

Status: Recruiting
Phase: —
Study type: Observational
Enrollment: 2,600 (estimated)

Sponsor: Heartland Health Research Alliance · Academic / Other
Sex: Female
Age: 18 Years
Healthy volunteers: Accepted

Summary

The Heartland Study is a prospective, observational study that will enroll up to 2,600 pregnant participants across the Heartland States in the U.S.. The objective of the Heartland Study is to address major knowledge gaps concerning the health effects of herbicides on maternal and infant health. The study is being conducted to evaluate the associations between environmental exposures to herbicides during and after pregnancy and reproductive health outcomes. The study is measuring multiple biomarkers of herbicide exposure among pregnant Midwesterners and their partners to evaluate associations with pregnancy and childbirth outcomes, epigenetic biomarkers of exposure, and child development.

Detailed description

During Phase 1 of the Study, newly pregnant mothers will be enrolled less than or equal to 20 weeks + 6 days gestation and followed through to the end of pregnancy. Prenatal urine and buccal (cheek) samples will be collected to measure urinary herbicide exposure levels and to identify herbicide induced epigenetic biomarkers. Pregnancy outcomes and fetal health will be documented and analyzed to further investigate potential effects of fetal exposure. Indirect measures such as food and beverage consumption, workplace and household related chemical exposures, substance use, residential proximity to agricultural fields, and socioeconomic factors will be captured from questionnaires.

Conditions

Timeline

Start date: 2020-01-11
Primary completion: 2027-01-01
Completion: 2029-01-01
First posted: 2022-08-08
Last updated: 2025-06-29

Locations

4 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT05492708. Inclusion in this directory is not an endorsement.