Pregnancy RelatedNCT03696368
The Hoosier Moms Cohort
An observational study of Pregnancy Related and Gestational Diabetes, run by Indiana University at 6 sites in United States.
Trial summary
The Hoosier Moms Cohort (HMC) study's goal is to better understand the pathophysiology underlying the development of gestational diabetes mellitus (GDM) in pregnant women and its transition to Type 2 diabetes mellitus in mothers and their exposed children. 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, Gestational Diabetes
- How many people
- 411 participants
- Where
- 6 sitesUnited States
- Study dates
- 4 Jan 2019to 15 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: 500 pregnant women with an enhanced risk of GDM will be recruited from obstetrical clinics associated with the Indiana University School of Medicine or by self referral.
Who may be able to join
- Singleton gestation
- Gestational age ≤ 20+0 confirmed via American Congress of Obstetrics and Gynecology (ACOG) ultrasound dating guidelines
- 18 years old or greater at time of consent
Who cannot join
- Pre pregnancy diagnosis of Type 1 Diabetes or Type 2 Diabetes or Screening Hemoglobin A1C that is greater than or equal to 6.5% or two abnormal values on a 3 hours Oral Glucose Tolerance Test (100g load) before 20 weeks gestation
- Pre pregnancy chronic usage of systemic steroids (inhaled and short term usage acceptable)
- Planned pregnancy termination
- Unable to provide informed consent in English or Spanish
- Major fetal anomalies as listed below that are known prior to enrollment. If these are discovered after enrollment, the participant may be allowed to participate, unless the discovered fetal anomaly is a lethal anomaly.
- Major Fetal Anomalies to be Excluded:
Show all 53Show fewer
- Congenital diaphragmatic hernia
- Congenital cystic adenomatoid malformation
- Pleural effusions
- Chylothorax
- Bronchogenic cyst
- Bronchopulmonary sequestration
- Anomalous pulmonary venous return
- Tricuspid atresia
- Mitral atresia
- Double right ventricle
- Ebstein's malformation
- Pulmonary atresia
- Hypoplastic left heart syndrome
- Aortic coarctation
- Fetal arrhythmias (tachycardia or bradycardia)
- Transposition of the great vessels
- Tetrology of Fallot
- Double outlet right ventricle
- Aortic stenosis
- Holoprosencephaly
- Anencephaly
- Dandy-Walker malformation or variant
- Septo-optic dysplasia
- Neural tube defect
- Vein of Galen aneurysm
- Bilateral renal agenesis
- Cystic renal disease (polycystic or multicystic)
- Any genitourinary lesion accompanied by oligohydramnios at <24 weeks
- Obstructive uropathy
- Horseshoe kidney
- Megacystis microcolon
- Achondrogenesis
- Thanatophoric dysplasia
- Thoracic dysplasia
- Osteogenesis imperfect
- Short rib polydactyly
- Any skeletal defect associated with small thorax
- Hypophosphatemia
- Any karyotypic abnormality
- Any suspected genetic syndrome
- Cleft lip/palate
- Micrognathia
- Hydrops
- Fetal anemia (<35% on cordocentesis)
- Neck mass
- Gastroschisis
- Omphalocele
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
IUH Coleman Center for Women
Indianapolis, Indiana, 46202
IUH Prenatal Diagnosis Clinic
Indianapolis, Indiana, 46202
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, 46202
Tri-state Perinatology at The Women's Hospital
Newburgh, Indiana, 47630
Women's Health Care PC
Newburgh, Indiana, 47630
About this study
Official title: Understanding Diverse Contributors to Gestational Diabetes Mellitus and Its Near-to-Long Term Consequences: An Indiana University Grand Challenges Precision Health Initiative Cohort Study (The Hoosier Moms Cohort)
The Hoosier Moms Cohort (HMC) study's goal is to better understand the pathophysiology underlying the development of gestational diabetes mellitus (GDM) in pregnant women and its transition to Type 2 diabetes mellitus in mothers and their exposed children.
The HMC study wants to determine what biomarkers (genetic, blood based and behavioral/interventional) can be identified in pregnant women affected with GDM and how those biomarkers can be used to impact preventative care.
Read the detailed description
Predictive GDM genetic risk models will be tested and refined in the Hoosier Moms Cohort. In addition to prospectively using genetic information to predict GDM risk, the Hoosier Moms Cohort will incorporate the use of wearable/digital devices for collection of detailed behavioral information, support development of novel dietary capture methods, and enable the collection of specimens specifically aimed at multiple 'omics' techniques to engage in a detailed, multidimensional assessment of pathophysiologic pathways and biomarkers.
- Conditions
- Pregnancy Related, Gestational Diabetes
- Medical subject headings
- Diabetes, Gestational
What is being measured
The primary outcome is the main question the study is designed to answer.
GDM Diagnosis
Number of subjects diagnosed with GDM
Measured: 42 weeks or less gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start4 Jan 2019
- Primary completion15 Jan 2023
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Haas, Indiana University
- Investigators
- David M Haas, MD, MS, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696368
- Sponsor's protocol ID
- 1808964513
- Status last verified
- Apr 2024
- First submitted
- 3 Oct 2018
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Diverse Contributors to Gestational Diabetes Mellitus and Its Near-to-Long Term Consequences: An Indiana University Grand Challenges Precision Health Initiative Cohort Study (The Hoosier Moms Cohort)
- ClinicalTrials.gov ID
- NCT03696368
- Acronym / sponsor ID
- 1808964513
- Conditions
- Pregnancy Related, Gestational Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 4 Oct 2018 (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 Hoosier Moms Cohort (HMC) study's goal is to better understand the pathophysiology underlying the development of gestational diabetes mellitus (GDM) in pregnant women and its transition to Type 2 diabetes mellitus in mothers and their exposed children.
The HMC study wants to determine what biomarkers (genetic, blood based and behavioral/interventional) can be identified in pregnant women affected with GDM and how those biomarkers can be used to impact preventative care.
Detailed description
Predictive GDM genetic risk models will be tested and refined in the Hoosier Moms Cohort. In addition to prospectively using genetic information to predict GDM risk, the Hoosier Moms Cohort will incorporate the use of wearable/digital devices for collection of detailed behavioral information, support development of novel dietary capture methods, and enable the collection of specimens specifically aimed at multiple 'omics' techniques to engage in a detailed, multidimensional assessment of pathophysiologic pathways and biomarkers.
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
- 500 pregnant women with an enhanced risk of GDM will be recruited from obstetrical clinics associated with the Indiana University School of Medicine or by self referral.
Key inclusion criteria (3 listed)
- Singleton gestation
- Gestational age ≤ 20+0 confirmed via American Congress of Obstetrics and Gynecology (ACOG) ultrasound dating guidelines
- 18 years old or greater at time of consent
Key exclusion criteria (53 listed)
- Pre pregnancy diagnosis of Type 1 Diabetes or Type 2 Diabetes or Screening Hemoglobin A1C that is greater than or equal to 6.5% or two abnormal values on a 3 hours Oral Glucose Tolerance Test (100g load) before 20 weeks gestation
- Pre pregnancy chronic usage of systemic steroids (inhaled and short term usage acceptable)
- Planned pregnancy termination
- Unable to provide informed consent in English or Spanish
- Major fetal anomalies as listed below that are known prior to enrollment. If these are discovered after enrollment, the participant may be allowed to participate, unless the discovered fetal anomaly is a lethal anomaly.
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
GDM Diagnosis
Time frame: 42 weeks or less gestational age
Number of subjects diagnosed with GDM
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
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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. This study is not recruiting at the moment.
David M Haas, MD, MS principal investigator
Indiana University
6 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 Gestational Diabetes, run by Indiana University at 6 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 3 inclusion and 53 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: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GDM Diagnosis (time frame: 42 weeks or less gestational age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2024.