The Hoosier Moms Cohort
Sponsor:
Indiana University
Collaborators:
Information provided by (Responsible Party):
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| Tracking Information | |||
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| First Submitted Date ICMJE | October 3, 2018 | ||
| First Posted Date ICMJE | October 4, 2018 | ||
| Last Update Posted Date | October 4, 2018 | ||
| Actual Study Start Date ICMJE | November 2018 | ||
| Estimated Primary Completion Date | November 2021 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
GDM Diagnosis[ Time Frame: 42 weeks or less gestational age ] Number of subjects diagnosed with GDM |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | The Hoosier Moms Cohort |
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| Official Title ICMJE | 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) |
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| 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. |
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| 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 ICMJE | Observational | ||
| Study Phase | |||
| Study Design ICMJE | Allocation: Intervention Model: Intervention Model Description: Masking: Observational Masking Description: Primary Purpose: |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Not yet recruiting | ||
| Estimated Enrollment ICMJE |
500 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | November 2025 | ||
| Estimated Primary Completion Date | November 2021 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | 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 | ||
| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | No | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | ， | ||
| Study Sponsor ICMJE | Indiana University | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | |||
| Verification Date | October 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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