Clinical trial NCT05492708: The Heartland Study
Official title: Children's Health in the Heartland Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy Related
Pregnancy Complications
Birth Defect
Gestational Age and Weight Conditions
Spontaneous Abortion
Miscarriage
Exposure to Herbicides
Keywords: pesticide exposure
birth outcomes
biomonitoring
Lead sponsor: Heartland Health Research Alliance
Sponsor class: OTHER
Collaborators: name: Indiana University School of Medicine
First posted: 2022-08-08
Enrollment: 2600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pregnancy loss
timeFrame: Enrollment to birth
measure: Preterm birth
timeFrame: Enrollment to gestational age 36 +6
measure: Hypertensive disorders of pregnancy
timeFrame: Enrollment to up to twelve weeks after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Health Care
state: Iowa
city: La Crosse
country: United States
facility: Gundersen Health
state: Wisconsin
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
Study officials:
References:
citation: 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.