The Hoosier Moms Cohort

NCT03696368 | Completed

• 1 other identifier: 1808964513
• Study Type: observational
• Target: 411
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Pregnancy Related; Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• GDM Diagnosis

  Number of subjects diagnosed with GDM

  42 weeks or less gestational age

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Singleton gestation
• Gestational age ≤ 20+0 confirmed via American Congress of Obstetrics and Gynecology (ACOG) ultrasound dating guidelines
• years old or greater at time of consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (6)

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

IUH Coleman Center for Women

Indianapolis, Indiana, 46202, United States

Location

IUH Prenatal Diagnosis Clinic

Indianapolis, Indiana, 46202, United States

Location

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

Location

Tri-state Perinatology at The Women's Hospital

Newburgh, Indiana, 47630, United States

Location

Women's Health Care PC

Newburgh, Indiana, 47630, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Maternal blood * Maternal urine * Maternal stool * Cord blood * Infant buccal swab

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• David M Haas, MD, MS

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics & Gynecology

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 4, 2018
• Study Start: January 4, 2019
• Primary Completion: January 15, 2023
• Study Completion: January 15, 2023
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

US (6)