Birth Defect, Exposure to Herbicides, Gestational Age and Weight Conditions, Miscarriage, Pregnancy Complications, Pregnancy Related, Spontaneous Abortion
Conditions
Keywords
pesticide exposure, birth outcomes, biomonitoring
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.
Interventions
None listed
Sponsors
Indiana University School of Medicine
Heartland Health Research Alliance
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy loss | Enrollment to birth | Number of participants who experience a pregnancy loss |
| Preterm birth | Enrollment to gestational age 36 +6 | Number of births that occur between gestational age 20 +0 and 36 +6 |
| Hypertensive disorders of pregnancy | Enrollment to up to twelve weeks after delivery | Number of participants diagnosed with a hypertensive disorder of pregnancy |
Countries
United States
Contacts
Primary ContactKathleen Flannery
Outcome results
None listed