The Heartland Study

Recruiting

• Conditions: Birth Defect; Pregnancy Related; Miscarriage; Gestational Age and Weight Conditions; Spontaneous Abortion; Pregnancy Complications; Exposure to Herbicides

• Registration Number: NCT05492708
• Lead Sponsor: Heartland Health Research Alliance

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.

Study Timeline

• Study Start: 2020-01-11
• Study First Submitted: 2022-08-05
• Study First Submitted QC: 2022-08-05
• Study First Posted: 2022-08-08
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-26
• Primary Completion: 2027-01
• Study Completion: 2029-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 2600

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pregnancy loss	Enrollment to birth	Number of participants who experience a pregnancy loss
Hypertensive disorders of pregnancy	Enrollment to up to twelve weeks after delivery	Number of participants diagnosed with a hypertensive disorder of pregnancy
Preterm birth	Enrollment to gestational age 36 +6	Number of births that occur between gestational age 20 +0 and 36 +6

Trial Locations

Locations (4)

Indiana University Medical Center; 🇺🇸 Indianapolis, Indiana, United States

University of Iowa Health Care; 🇺🇸 Iowa City, Iowa, United States

Gundersen Health; 🇺🇸 La Crosse, Wisconsin, United States

Marshfield Clinic; 🇺🇸 Marshfield, Wisconsin, United States