The Heartland Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Children's Health in the Heartland Study

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

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pesticide exposure, birth outcomes, biomonitoring