An observational study in Gestational Diabetes, sponsored by Mount Carmel Health System. Withdrawn at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-06.
Sponsored by Mount Carmel Health System · Observational
Among 251 studies in Diabetes, Gestational with a site in United States — 53 open to participants now, 65 under way, 2 of them phase 3. Diabetes, Gestational · United States.
Among the 251 studies in Diabetes, Gestational with a site in United States, this one is the 54th largest by enrollment of the 57 observational ones, is one of 22 that started in 2021, is one of 57 observational ones, and was the 166th registered.
877 studies on the registry are indexed under Diabetes, Gestational; 203 are open to participants now.
Browse Diabetes, Gestational studies →53 of the 251 studies in Diabetes, Gestational with a site in United States are open now, in 2 countries. Each count lists the studies.
Of the 139 Diabetes, Gestational studies recruiting now, 63 (45%) set no upper age limit and 74 (53%) stop at 75 or younger; 14 take children under 18; 63 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →251 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 22 started in 2021.
Median enrollment 80 across the 194 interventional studies, 72 across the 57 observational. Of the 154 that completed or were terminated, 35 (23%) have results posted.
10 of 251 have an industry lead sponsor. The 10 most frequent:
Mount Carmel Health System is the lead sponsor of 12 studies on the registry; none are open to participants now.
Mount Carmel Health System has 1 study filed under Diabetes, Gestational — fewer than ten, so there is no comparison to draw.
22 of the studies in Diabetes, Gestational with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07356180University of Maryland, BaltimorePhysical Acvitiy in Pregnancy | 2026-12 |
| NCT05909046Ohio State UniversityA Randomized Controlled Trial of Diabetes Screening Immediately Postpartum (DIP) and Follow Up PP CARE | 2026-12 |
| NCT05388643University of Massachusetts, WorcesterEarly Detection of Gestational Diabetes Mellitus in Pregnancy | 2026-12-01 |
| NCT07176793University of California, DavisPregnancy and Postpartum Breastfeeding Support for Patients With Gestational Diabetes | 2026-12-30 |
| NCT05124808Indiana UniversityIntensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes | 2026-12-31 |
Among the 251 studies in Diabetes, Gestational with a site in United States, from their registry updates:
Gestational Diabetes Mellitus (GDM) is a common metabolic complication of pregnancy defined as new onset hyperglycemia during gestation. GDM conveys significant risk of morbidity and mortality for both mother and infant. An estimated 268,900 infants were born to mothers with GDM in the USA, accounting for approximately 6.9% of births. Although individual correlations have been found between elevated GGT and uric acid levels and later development of GDM, no research has established and validated combined criteria for GGT and uric acid levels that would lead to their use in identifying women at high risk of GDM in the first trimester.
Central Hypothesis: Serum GGT and serum uric acid collected between >9-14.0 weeks gestation will be significantly elevated in women who later develop GDM compared to those who do not. Combined analysis of serum uric acid and GGT levels within the first trimester allows for accurate prediction of the development of GDM.
Study population includes women between 9-14 weeks gestation undergoing a standard first trimester blood draw. Additional blood will be drawn during the standard blood draw to assess GGT and uric acid levels. Research participants will be tracked afterwards to determine whether they tested positive for gestational diabetes during the standard testing process which typically occurs at 24-28 weeks gestation. The data will then be analyzed to estimate the sensitivity, specificity, positive and negative predictive values of the first trimester GGT and uric acid tests. The GGT and uric acid levels which maximize the area under the receiver-operator characteristic curve will be identified.
Pregnant women between > 9 weeks and \< 14 and 0 weeks gestation presenting to the OB clinic for prenatal care
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Women attending an initial first trimester prenatal visit who will be undergoing a standard blood draw.
Diagnostic Test: GGT/Uric Acid
Standard laboratory blood testing for GGT and uric acid levels.
Proportion of patients diagnosed with gestational diabetes mellitus
Diagnosis of gestational diabetes mellitus (GDM) via oral glucose tolerance testing (Carpenter and Coustan criteria)
Time frame: 24-28 weeks
Plan to share: No — There is no plan to share individual participant data with others. Study data may be requested from the sponsor or investigator.
No publications or documents are linked to this record.
Started Jun 2021 (actual). Primary completion is estimated for Jun 2024, 36 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Mount Carmel Health System