Children's Health in the Heartland Study
The Heartland Study
Sponsors
Source
Heartland Health Research Alliance
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
Brief 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.
Overall Status
Recruiting
Start Date
2020-01-11
Completion Date
2029-01-01
Primary Completion Date
2027-01-01
Study Type
Observational
Primary Outcome
Measure |
Time Frame |
|
Pregnancy loss |
Enrollment to birth |
|
Preterm birth |
Enrollment to gestational age 36 +6 |
|
Hypertensive disorders of pregnancy |
Enrollment to up to twelve weeks after delivery |
Enrollment
2600
Conditions
Eligibility
Study Pop
Participants must live in one of the 13 Heartland states at the time of enrollment:
Arkansas, Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, North
Dakota, Ohio, South Dakota, Wisconsin.
Sampling Method
Non-Probability Sample
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
Gender
Female
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
Accepts Healthy Volunteers
Overall Contact
Last Name
Kathleen Flannery
Phone
317-880-3961
kamaflan@iu.edu
Location
Facility |
Status |
Contact |
Investigator |
|
Indiana University Medical Center Indianapolis 4259418 Indiana 4921868 46202 United States |
Recruiting |
Last Name: Kathleen Flannery Email: hhra@iu.edu |
Last Name: David Haas, MD Role: Principal Investigator |
|
University of Iowa Health Care Iowa City 4862034 Iowa 4862182 52242 United States |
Recruiting |
Last Name: Donna Santillan, PhD | |
|
Gundersen Health La Crosse 5258957 Wisconsin 5279468 54601 United States |
Completed | ||
|
Marshfield Clinic Marshfield 5261969 Wisconsin 5279468 54449 United States |
Recruiting |
Last Name: Melissa Slager Email: HeartlandStudy@marshfieldresearch.org |
Last Name: Peter Johnson, MD Role: Principal Investigator |
Location Countries
Country
United States
Verification Date
2025-06-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Firstreceived Results Date
N/A
Biospec Retention
Samples With DNA
Biospec Descr
Maternal and paternal urine samples, and maternal, paternal, and infant buccal samples
Reference
Citation
Parvez S, Gerona RR, Proctor C, Friesen M, Ashby JL, Reiter JL, Lui Z, Winchester PD. Glyphosate exposure in pregnancy and shortened gestational length: a prospective Indiana birth cohort study. Environ Health. 2018 Mar 9;17(1):23. doi: 10.1186/s12940-018-0367-0.
PMID
29519238
Patient Data
Sharing Ipd
Undecided
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Cohort
Time Perspective
Prospective
Study First Submitted
August 5, 2022
Study First Submitted Qc
August 5, 2022
Study First Posted
August 8, 2022
Last Update Submitted
June 25, 2025
Last Update Submitted Qc
June 25, 2025
Last Update Posted
June 29, 2025
ClinicalTrials.gov processed this data on October 31, 2025
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.