Recruiting

Observational Study

Sponsor:

Heartland Health Research Alliance

Code:

NCT05492708

Conditions

Pregnancy Related

Pregnancy Complications

Birth Defect

Gestational Age and Weight Conditions

Spontaneous Abortion

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Pregnancy Related

Pregnancy Complications

Birth Defect

Gestational Age and Weight Conditions

Spontaneous Abortion

Study ID

NCT05492708

Start date

Jan 11, 2020

Status verified date

Jun, 2025

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

2600 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Pregnancy loss [ Time Frame: Enrollment to birth ]
  • Preterm birth [ Time Frame: Enrollment to gestational age 36 +6 ]
  • Hypertensive disorders of pregnancy [ Time Frame: Enrollment to up to twelve weeks after delivery ]

Central Contacts and Locations

Central contacts

Kathleen Flannery

317-880-3961kamaflan@iu.edu

Locations

Indiana University Medical Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Kathleen Flannery

hhra@iu.edu

Principal Investigator:

David Haas, MD

University of Iowa Health Care

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Ashlyn Kenney

ashlyn-mulcahey@uiowa.edu

Marshfield Clinic

Recruiting

Marshfield, Wisconsin, United States, 54449

Contacts

Melissa Slager

HeartlandStudy@marshfieldresearch.org

Principal Investigator:

Peter Johnson, MD

More Information

Sponsor

Heartland Health Research Alliance

Last update posted

Jun 29, 2025

Last verified

Jun, 2025

Keywords

  • pesticide exposure
  • birth outcomes
  • biomonitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Heartland Health Research Alliance on 2025-06-29.