Research on herbicide exposure effects during pregnancy
Children's Health in the Heartland Study
This study is trying to see how exposure to herbicides during pregnancy affects the health of mothers and their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2600 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Heartland Health Research Alliance Academic / other |
| Locations | 4 sites (Indianapolis, Indiana and 3 other locations) |
| Trial ID | NCT05492708 on ClinicalTrials.gov |
What this trial studies
The Heartland Study is a prospective, observational study enrolling up to 2,600 pregnant individuals across the Heartland States in the U.S. It aims to investigate the health effects of herbicides on maternal and infant health by measuring biomarkers of herbicide exposure and evaluating their associations with pregnancy outcomes. Participants will provide urine and buccal samples, and data will be collected through questionnaires regarding various environmental and lifestyle factors. The study will follow participants from early pregnancy through childbirth to assess potential impacts on fetal health and child development.
Who should consider this trial
Good fit: Ideal candidates are pregnant individuals aged 18 or older who are less than or equal to 20 weeks pregnant and reside in one of the 13 Heartland Study region states.
Not a fit: Patients who are not fluent in English or unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the effects of herbicide exposure on pregnancy outcomes, potentially leading to improved health guidelines for pregnant individuals.
How similar studies have performed: Other studies have shown success in evaluating environmental exposures and their effects on pregnancy outcomes, making this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant persons ages 18 or older at time of consent who are ≤20+6 weeks pregnant. Best clinical estimate of gestational age will be utilized for recruitment purposes. Enrollment in the first trimester (≤ 13 + 6) is preferred, but anyone ≤ 20 +6 is permitted. * Living in one of the 13 Heartland Study region states at the time of enrollment (Arkansas, Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, North Dakota, Ohio, South Dakota, or Wisconsin) Optional inclusion of the putative biological father Exclusion Criteria: * Participants who are not fluent in and/or do not fully understand, read, write, or speak the English language. * Other inability to provide informed consent to participate
Where this trial is running
Indianapolis, Indiana and 3 other locations
- Indiana University Medical Center — Indianapolis, Indiana, United States (Recruiting)
- University of Iowa Health Care — Iowa City, Iowa, United States (Recruiting)
- Gundersen Health — La Crosse, Wisconsin, United States (Completed)
- Marshfield Clinic — Marshfield, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Kathleen Flannery
- Email: kamaflan@iu.edu
- Phone: 317-880-3961
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.