ClinicalTrials.gg
RecruitingNCT05492708Updated Jun 29, 2025

The Heartland Study

An observational study in Pregnancy Related, Pregnancy Complications and Birth Defect, sponsored by Heartland Health Research Alliance. Recruiting at 4 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-29.

Primary conditionAbortion, SpontaneousRegistry: Pregnancy ComplicationsReclassifiedWhy we changed it
Registry
Pregnancy Complications — the first condition term the registry derived for this study.
ClinicalTrials.gg
Abortion, Spontaneous
Why
  1. The study's listed conditions name Abortion, Spontaneous, a narrower term within Pregnancy Complications.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Heartland Health Research Alliance · Observational

From the registry’s dates

  • Started Jan 2020; still recruiting 6 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,600
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

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

Browse trials for

Keywords

  • pesticide exposure
  • birth outcomes
  • biomonitoring
03

In context

Abortion, Spontaneous Reclassified

221 studies on the registry are indexed under Abortion, Spontaneous; 44 are open to participants now.

This study's planned enrollment of 2,600 is above the median of 201 across 98 observational studies indexed under Abortion, Spontaneous.

Browse Abortion, Spontaneous studies →

Lead sponsor

This is the only study on the registry with Heartland Health Research Alliance as lead sponsor.

Compared within Abortion, Spontaneous, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pregnancy Complications. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 to participate
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,600 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

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

07

Study locations

3 of 4 sites recruiting
08

References and documents

Publications

  • 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. PubMed 29519238 ↗
  • Freisthler M, Winchester PW, Young HA, Haas DM. Perinatal health effects of herbicides exposures in the United States: the Heartland Study, a Midwestern birth cohort study. BMC Public Health. 2023 Nov 22;23(1):2308. doi: 10.1186/s12889-023-17171-9. PubMed 37993831 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05492708
Lead sponsor
Heartland Health Research Alliance
Collaborators
Indiana University School of Medicine
Responsible party
Sponsor
First posted
Aug 8, 2022
Start date
Jan 11, 2020
Primary completion
Jan 2027 (estimated)
Completion
Jan 2029 (estimated)
Last update
Jun 29, 2025

Study contacts

Kathleen Flannery
Contact
kamaflan@iu.edu
317-880-3961

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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