N/A
N=962
Early Gestational Diabetes Screening in the Gravid Obese Woman
Gestational Diabetes · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01864564 ↗Enrolled (actual)
962
Serious AEs
3.5%
Results posted
Jun 2020
Primary outcome: Primary: Number of Participants With a Composite Perinatal Outcome — 235; 261 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Early Screen (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Composite Perinatal Outcome |
235; 261 | — |
| SECONDARY Number of Participants With Macrosomia |
21; 25 | — |
| SECONDARY Primary Cesarean Delivery |
93; 79 | — |
| SECONDARY Pregnancy Induced Hypertension |
102; 136 | — |
| SECONDARY Shoulder Dystocia |
32; 30 | — |
| SECONDARY Neonatal Hyperbilirubinemia |
72; 90 | — |
| SECONDARY Neonatal Hypoglycemia |
19; 22 | — |
| SECONDARY Gestational Age at Delivery |
38.5; 38.2 | — |
| SECONDARY Any Diabetic Medication |
20; 31 | — |
| SECONDARY Insulin Medication |
3; 11 | — |
| SECONDARY Large for Gestational Age |
26; 27 | — |
Summary
Specific Aim 1: To test the hypothesis that early GDM screening between 14-18 weeks in obese women (body mass index ≥30.0) will result in improved perinatal outcomes.
Specific Aim 2: To test the hypothesis that a lower diagnostic threshold for GDM at 14-18 weeks will result in improved detection of GDM and reduce the need for third-trimester testing.
Specific Aim 3: To test the hypothesis that 1,5-anhydroglucitol, a sensitive marker of hyperglycemia, can be used as a simple and sensitive serum test for GDM in the obese population.
Eligibility Criteria
Inclusion Criteria
- Pregnant
- 18 years and older
- Body mass index >=30.0
- <20 weeks gestation at presentation for care
Exclusion Criteria
- Prior cesarean
- History of bariatric surgery
- Major maternal medical illness (cardiac disease, HIV, hemoglobinopathy, oxygen requirement)
- Chronic prednisone use
- Known fetal anomalies
- Multifetal gestation
Data sourced from ClinicalTrials.gov (NCT01864564). 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.