Actively Recruiting

Age: 18Years +
FEMALE
Healthy Volunteers
ID05492708

Children's Health in the Heartland Study

Led by Heartland Health Research Alliance · Updated on 2025-06-29

2600

Participants Needed

4

Research Sites

104 weeks

Total Duration

On this page

Sponsors

H

Heartland Health Research Alliance

Lead Sponsor

I

Indiana University

Collaborating Sponsor

AI-Summary

What this Trial Is About

The Heartland Study is a prospective observational research project enrolling up to 2,600 pregnant participants across the Heartland States in the U.S. It aims to fill important knowledge gaps about how herbicide exposure affects maternal and infant health. Researchers will examine links between environmental herbicide exposure during and after pregnancy and outcomes related to reproduction, childbirth, and child development, including epigenetic biomarkers of exposure. During the first phase, pregnant participants up to 20 weeks and 6 days gestation will be enrolled and followed through to the end of pregnancy. Urine and cheek cell samples will be collected to measure herbicide exposure and identify related epigenetic changes. The study will also gather information through questionnaires about food and drink habits, chemical exposures at work and home, substance use, living near agricultural fields, and socioeconomic factors. Participants will have their pregnancy outcomes and fetal health tracked and analyzed to explore potential effects of herbicide exposure on the fetus. Researchers will monitor pregnancy loss, preterm birth, and hypertensive disorders up to 12 weeks after delivery. The study includes questionnaires and biological sample collection during pregnancy to assess exposure and health outcomes. Overall participation lasts through pregnancy and shortly after delivery, providing comprehensive data on maternal and infant health in relation to herbicide exposure.

CONDITIONS

Brief Title

The Heartland Study

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant persons aged 18 years or older at time of consent who are less than or equal to 20 weeks and 6 days pregnant
  • Enrollment in the first trimester (less than or equal to 13 weeks and 6 days) is preferred but not required
  • Living in one of the 13 Heartland Study region states: Arkansas, Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, North Dakota, Ohio, South Dakota, or Wisconsin
  • Optional inclusion of the putative biological father
Not Eligible

You will not qualify if you...

  • Participants who are not fluent in and/or do not fully understand, read, write, or speak the English language
  • Inability to provide informed consent to participate

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote)

Monitoring

Duration - From enrollment through delivery

Participants are followed through pregnancy to document pregnancy outcomes and fetal health, including collection of prenatal urine and cheek samples, questionnaires on environmental exposures, and indirect measures such as food and beverage consumption and residential proximity to agricultural fields.

Multiple visits timed with pregnancy milestones

Long-term Monitoring

Duration - Up to 12 weeks after delivery

Participants are monitored for up to twelve weeks after delivery to assess hypertensive disorders of pregnancy and other outcomes.

Approximately 2 to 3 follow-up visits postpartum

Trial Site Locations

Total: 4 locations

1

Indiana University Medical Center

Indianapolis, Indiana, United States, 46202

Actively Recruiting

2

University of Iowa Health Care

Iowa City, Iowa, United States, 52242

Actively Recruiting

3

Gundersen Health

La Crosse, Wisconsin, United States, 54601

Completed

4

Marshfield Clinic

Marshfield, Wisconsin, United States, 54449

Actively Recruiting

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Research Team

K

Kathleen Flannery

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Perinatal health effects of herbicides exposures in the United States: the Heartland Study, a Midwestern birth cohort study.

Marlaina Freisthler, Paul W Winchester, Heather A Young...

https://pubmed.ncbi.nlm.nih.gov/37993831