The Hoosier Moms Cohort

Pregnancy Related Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03696368
• Other study ID #: 1808964513
• Status: Completed
• Start date: January 4, 2019
• Est. completion date: January 15, 2023

Study information

• Verified date: April 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 411
• Est. completion date: January 15, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes
• Pregnancy Related

Locations

Country	Name	City	State
United States	IU Health Methodist Hospital	Indianapolis	Indiana
United States	IUH Coleman Center for Women	Indianapolis	Indiana
United States	IUH Prenatal Diagnosis Clinic	Indianapolis	Indiana
United States	Sidney and Lois Eskenazi Hospital	Indianapolis	Indiana
United States	Tri-state Perinatology at The Women's Hospital	Newburgh	Indiana
United States	Women's Health Care PC	Newburgh	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GDM Diagnosis	Number of subjects diagnosed with GDM	42 weeks or less gestational age