The Heartland Study

Pregnancy Related Clinical Trial

Official title:

Children's Health in the Heartland Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05492708
• Other study ID #: HHRA-HS-Phase1-2019
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

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

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

External Links

•   Sponsor Website
•   Study Webpage