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| Name | Class |
|---|---|
| Indiana University | OTHER |
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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.
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.
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Participants must live in one of the 13 Heartland states at the time of enrollment: Arkansas, Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, North Dakota, Ohio, South Dakota, Wisconsin.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathleen Flannery | Contact | 317-880-3961 | kamaflan@iu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Medical Center | Recruiting | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29519238 | Background | Parvez S, Gerona RR, Proctor C, Friesen M, Ashby JL, Reiter JL, Lui Z, Winchester PD. Glyphosate exposure in pregnancy and shortened gestational length: a prospective Indiana birth cohort study. Environ Health. 2018 Mar 9;17(1):23. doi: 10.1186/s12940-018-0367-0. | |
| 37993831 | Derived | Freisthler M, Winchester PW, Young HA, Haas DM. Perinatal health effects of herbicides exposures in the United States: the Heartland Study, a Midwestern birth cohort study. BMC Public Health. 2023 Nov 22;23(1):2308. doi: 10.1186/s12889-023-17171-9. |
| Label | URL |
|---|---|
| Sponsor Website | View source |
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| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D000013 | Congenital Abnormalities |
| D000022 | Abortion, Spontaneous |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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Maternal and paternal urine samples, and maternal, paternal, and infant buccal samples
| University of Iowa Health Care | Recruiting | Iowa City | Iowa | 52242 | United States |
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| Gundersen Health | Completed | La Crosse | Wisconsin | 54601 | United States |
| Marshfield Clinic | Recruiting | Marshfield | Wisconsin | 54449 | United States |
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| Study Webpage | View source |