At a glance
ClinicalIndex Comparison RecordN/ACompleted· 7,381 enrolled
Drug / intervention
nutritional counseling +1 morebehavioral
Likely dose
Not stated in record
Key inclusion· 2
- ✓Pregnant at enrollment
- ✓Gestational age 24–31 weeks at enrollment
Key exclusion· 14
- ✕Diabetes diagnosed prior to pregnancy
- ✕Abnormal GDM screening (≥135 mg/dL) prior to 24 weeks
- ✕History of gestational diabetes in a previous pregnancy
- ✕History of stillbirth or fetal death
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Clinical Trial of Treatment for Mild Gestational Diabetes Mellitus
The George Washington University Biostatistics Center·interventional·Posted Sep 30, 2003·Updated Jul 15, 2019
In Brief
A clinical study evaluating nutritional counseling and self blood glucose monitoring for Diabetes, Gestational. Completed, enrolled 7,381 participants across 16 sites.
Detailed Summary
Gestational diabetes mellitus (GDM) is a type of diabetes (high blood sugar) that occurs in pregnant women. This study will determine whether treating pregnant women who have mild GDM improves the health of their babies. The follow-up study will examine whether factors during the previous pregnancy (such as blood sugar during pregnancy) are associated with the woman and her child's health 4-9 years later.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Gestational
CountriesUnited States
Timeline
N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2002
First PostedSep 2003
Primary CompletionNov 2007
Study CompletionOct 2013
TodayJul 2026
First PostedSep 30, 2003
Enrollment StartOct 1, 2002
Primary CompletionNov 1, 2007
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 22.8 years ago
Interventions
nutritional counselingbehavioral
self blood glucose monitoringbehavioral