The Heartland Study

Phase

N/A

Condition

Pregnancy Complications

Miscarriage

Pregnancy

Treatment

N/A

Clinical Study ID

NCT05492708

HHRA-HS-Phase1-2019

Ages > 18
Female
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 ispermitted.
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 putativebiological father

Exclusion

Exclusion Criteria:

Participants who are not fluent in and/or do not fully understand, read, write, orspeak the English language.
Other inability to provide informed consent to participate

Study Design

January 11, 2020

January 31, 2029

Study 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.

Connect with a study center

Franciscan Health Indianapolis
Indianapolis, Indiana 46237
United States
Site Not Available
Indiana University Medical Center
Indianapolis, Indiana 46202
United States
Active - Recruiting
University of Iowa Health Care
Iowa City, Iowa 52242
United States
Active - Recruiting
Gundersen Health
La Crosse, Wisconsin 54601
United States
Completed
Marshfield Clinic
Marshfield, Wisconsin 54449
United States
Active - Recruiting

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