The Heartland Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorHeartland Health Research Alliance

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Pregnancy loss

Number of participants who experience a pregnancy loss

Time frame
Enrollment to birth
2

Preterm birth

Number of births that occur between gestational age 20 +0 and 36 +6

Time frame
Enrollment to gestational age 36 +6
3

Hypertensive disorders of pregnancy

Number of participants diagnosed with a hypertensive disorder of pregnancy

Time frame
Enrollment to up to twelve weeks after delivery

Secondary outcomes

Other outcomes

Sponsors and contacts

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