Pregnancy RelatedNCT05492708
The Heartland Study
An observational study of Pregnancy Related and Pregnancy Complications, run by Heartland Health Research Alliance at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Pregnancy Complications, Birth Defect
- How many people
- 2,600 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Jan 2020to Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 3 recruiting
- Recruiting
Indiana University Medical Center
Indianapolis, Indiana, 46202
Kathleen Flannery, hhra@iu.edu
David Haas, MD
- Recruiting
University of Iowa Health Care
Iowa City, Iowa, 52242
Donna Santillan, PhD
Ashlyn Kenney, ashlyn-mulcahey@uiowa.edu
- Completed
Gundersen Health
La Crosse, Wisconsin, 54601
- Recruiting
Marshfield Clinic
Marshfield, Wisconsin, 54449
Melissa Slager, HeartlandStudy@marshfieldresearch.org
Peter Johnson, MD
About this study
Official title: Children's Health in the Heartland Study
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.
- Conditions
- Pregnancy Related, Pregnancy Complications, Birth Defect, Gestational Age and Weight Conditions, Spontaneous Abortion, Miscarriage
- Keywords
- pesticide exposure, birth outcomes, biomonitoring
- Medical subject headings
- Pregnancy Complications, Congenital Abnormalities, Abortion, Spontaneous
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy loss
Number of participants who experience a pregnancy loss
Measured: Enrollment to birth
Preterm birth
Number of births that occur between gestational age 20 +0 and 36 +6
Measured: Enrollment to gestational age 36 +6
Hypertensive disorders of pregnancy
Number of participants diagnosed with a hypertensive disorder of pregnancy
Measured: Enrollment to up to twelve weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start11 Jan 2020
- Primary completionJan 2027 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heartland Health Research Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492708
- Sponsor's protocol ID
- HHRA-HS-Phase1-2019
- Status last verified
- Jun 2025
- First submitted
- 5 Aug 2022
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 29519238Freisthler 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children's Health in the Heartland Study
- ClinicalTrials.gov ID
- NCT05492708
- Acronym / sponsor ID
- HHRA-HS-Phase1-2019
- Conditions
- Pregnancy Related, Pregnancy Complications, Birth Defect, Gestational Age and Weight Conditions, Spontaneous Abortion, Miscarriage
- Keywords
- pesticide exposure, birth outcomes, biomonitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,600 participants (estimated)
- Lead sponsor
- Heartland Health Research AllianceUniversity, hospital or other
- Collaborators
- Indiana University
- Study start
- 11 Jan 2020 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pregnancy loss
Time frame: Enrollment to birth
Number of participants who experience a pregnancy loss
Preterm birth
Time frame: Enrollment to gestational age 36 +6
Number of births that occur between gestational age 20 +0 and 36 +6
Hypertensive disorders of pregnancy
Time frame: Enrollment to up to twelve weeks after delivery
Number of participants diagnosed with a hypertensive disorder of pregnancy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Background: PubMed 29519238Parvez 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.
- Derived from this study: PubMed 37993831Freisthler 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.
- Sponsor WebsiteLink provided by the sponsor.
- Study WebpageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Pregnancy Complications, run by Heartland Health Research Alliance at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathleen Flannery (317-880-3961, kamaflan@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy loss (time frame: Enrollment to birth). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05492708, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.