The Hoosier Moms Cohort
Status: | Recruiting |
---|---|
Conditions: | Women's Studies |
Therapuetic Areas: | Reproductive |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/24/2019 |
Start Date: | January 4, 2019 |
End Date: | November 2025 |
Contact: | David M Haas, MD, MS |
Email: | dahaas@iu.edu |
Phone: | 317-880-3960 |
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.
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.
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.
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.
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
We found this trial at
4
sites
Indianapolis, Indiana 46202
Principal Investigator: David M Haas, MD, MS
Phone: 317-880-3961
Click here to add this to my saved trials
Indianapolis, Indiana 46202
Principal Investigator: David M Haas, MD, MS
Phone: 317-880-3961
Click here to add this to my saved trials
Indianapolis, Indiana 46202
Principal Investigator: David M Haas, MD, MS
Phone: 317-880-3961
Click here to add this to my saved trials
Click here to add this to my saved trials