NCT05492708

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,600

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jan 2020Jan 2029

Study Start

First participant enrolled

January 11, 2020

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

7 years

First QC Date

August 5, 2022

Last Update Submit

June 25, 2025

Conditions

Pregnancy RelatedPregnancy ComplicationsBirth DefectGestational Age and Weight ConditionsSpontaneous AbortionMiscarriageExposure to Herbicides

Keywords

pesticide exposurebirth outcomesbiomonitoring

Outcome Measures

Primary Outcomes (3)

  • Pregnancy loss

    Number of participants who experience a pregnancy loss

    Enrollment to birth

  • Preterm birth

    Number of births that occur between gestational age 20 +0 and 36 +6

    Enrollment to gestational age 36 +6

  • Hypertensive disorders of pregnancy

    Number of participants diagnosed with a hypertensive disorder of pregnancy

    Enrollment to up to twelve weeks after delivery

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Iowa Health Care

Iowa City, Iowa, 52242, United States

RECRUITING

Gundersen Health

La Crosse, Wisconsin, 54601, United States

COMPLETED

Marshfield Clinic

Marshfield, Wisconsin, 54449, United States

RECRUITING

Related Publications (2)

  • 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: 29519238BACKGROUND

  • Freisthler M, Winchester PW, Young HA, Haas DM. Perinatal health effects of herbicides exposures in the United States: the Heartland Study, a Midwestern birth cohort study. BMC Public Health. 2023 Nov 22;23(1):2308. doi: 10.1186/s12889-023-17171-9.

    PMID: 37993831DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Maternal and paternal urine samples, and maternal, paternal, and infant buccal samples

MeSH Terms

Conditions

Pregnancy ComplicationsCongenital AbnormalitiesAbortion, Spontaneous

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Kathleen Flannery

CONTACT

317-880-3961kamaflan@iu.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2022

First Posted

August 8, 2022

Study Start

January 11, 2020

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2029

Last Updated

June 29, 2025

Record last verified: 2025-06

Locations

US(4)