The Hoosier Moms Cohort

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Gestational Diabetes

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 Type: Observational
• Enrollment (Actual): 411

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Sidney and Lois Eskenazi Hospital
    • Indianapolis, Indiana, United States, 46202
      • IU Health Methodist Hospital
    • Indianapolis, Indiana, United States, 46202
      • IUH Coleman Center for Women
    • Indianapolis, Indiana, United States, 46202
      • IUH Prenatal Diagnosis Clinic
    • Newburgh, Indiana, United States, 47630
      • Tri-state Perinatology at The Women's Hospital
    • Newburgh, Indiana, United States, 47630
      • Women's Health Care PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GDM Diagnosis	Number of subjects diagnosed with GDM	42 weeks or less gestational age

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: David M Haas, MD, MS, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2019
• Primary Completion (Actual): January 15, 2023
• Study Completion (Actual): January 15, 2023

Study Registration Dates

• First Submitted: October 3, 2018
• First Submitted That Met QC Criteria: October 3, 2018
• First Posted (Actual): October 4, 2018

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes, Gestational
• Other Study ID Numbers: 1808964513

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No