Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05492708

The Heartland Study

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Pregnancy Related Abortion, Spontaneous Birth Defect Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Exposure to Herbicides Female Urogenital Diseases and Pregnancy Complications Gestational Age and Weight Conditions Miscarriage Pregnancy Complications Spontaneous Abortion Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Indiana University Medical Center, Indianapolis, Indiana, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Pregnancy loss

    Time frame: Enrollment to birth

    Number of participants who experience a pregnancy loss

  2. Preterm birth

    Time frame: Enrollment to gestational age 36 +6

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

  3. Hypertensive disorders of pregnancy

    Time frame: Enrollment to up to twelve weeks after delivery

    Number of participants diagnosed with a hypertensive disorder of pregnancy

Study contacts

Contact information is provided by the study sponsor or research team.

Kathleen Flannery

CONTACT

[email protected]

317-880-3961

Sponsors and collaborators

Lead sponsor

Heartland Health Research Alliance

Other

Collaborators

  • Indiana University

Registry information

Official study title

Children's Health in the Heartland Study

Important dates

Study start
2020
Primary completion
2027
Study completion
2029
First posted
Aug 8, 2022
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.