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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05492708
Other study ID # HHRA-HS-Phase1-2019
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 11, 2020
Est. completion date January 2029

Study information

Verified date April 2024
Source Heartland Health Research Alliance
Contact Kathleen Flannery
Phone 317-880-3961
Email kamaflan@iu.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2600
Est. completion date January 2029
Est. primary completion date January 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
United States Indiana University Medical Center Indianapolis Indiana
United States University of Iowa Health Care Iowa City Iowa
United States Gundersen Health La Crosse Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
Heartland Health Research Alliance Indiana University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pregnancy loss Number of participants who experience a pregnancy loss Enrollment to birth
Primary Preterm birth Number of births that occur between gestational age 20 +0 and 36 +6 Enrollment to gestational age 36 +6
Primary 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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