N/A
N=921
Comparison of Two Screening Strategies for Gestational Diabetes (GDM2)
Gestational Diabetes · Pregnancy · Glucose Intolerance
Bottom Line
View on ClinicalTrials.gov: NCT02309138 ↗Enrolled (actual)
921
Serious AEs
2.1%
Results posted
Jul 2020
Primary outcome: Primary: Large for Gestational Age (LGA) Infant — 34; 35; 28; 34 Participants — p=0.668
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Gestational diabetes screening with fasting 3 hour 100 gm (Diagnostic_test); Gestational diabetes screening with fasting 2 hour 75g (Diagnostic_test)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Esa M Davis, MD MPH FAAFP
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Large for Gestational Age (LGA) Infant |
34; 35; 28; 34 | 0.668 |
| SECONDARY Cesarean Delivery |
131; 118; 101; 101 | 0.6669 |
| SECONDARY Maternal Composite Morbidity |
77; 75; 62; 63 | 0.9335 |
| SECONDARY Neonatal Composite Morbidity |
83; 57; 57; 48 | 0.0322 sig |
Summary
This is a single site blinded RCT of 920 pregnant women with singleton gestation designed to compare the Carpenter-Coustan and IADPSG criteria for diagnosing gestational diabetes. Maternal metabolic profiles and infant growth will be assessed at randomization and at one year postpartum.
Eligibility Criteria
Inclusion Criteria
- Pregnancy between 18-24 weeks of gestation
- Singleton gestation
- Planning to deliver at Magee-Womens Hospital, Pittsburgh, Pennsylvania
Exclusion Criteria
- Preexisting type 1 or 2 diabetes
- Diabetes diagnosed at less than 24 weeks gestational age (GA)
- Multiple gestations ( e.g. twins or triplets)
- Hypertension requiring medications
- Corticosteroid (IM, oral or IV) use in the 30 days prior to enrollment
- Major congenital anomaly with anticipated preterm delivery due to maternal or fetal indications < 28 wks GA
- Inability to complete the glucose testing before 30 completed weeks GA
- Advanced HIV( on medications that cause hyperglycemia), severe liver disease, gastric bypass surgery or other illness/surgeries that preclude them from drinking the glucola solution.
Data sourced from ClinicalTrials.gov (NCT02309138). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.