N/A
Completed N=95
Early Screening and Treatment of Women With Prediabetes in Pregnancy
Source: ClinicalTrials.gov NCT01552213 ↗Enrolled (actual)
95
Serious AEs
1.1%
Results posted
Jan 2019
Primary outcomePrimary: Number of Patients With a Diagnosis of Gestational Diabetes at 26 Weeks Gestation. — 19; 23 Participants — p=0.32
Summary
The investigators hope to learn whether treatment with medical nutrition therapy (MNT) for pregnant women with prediabetes decreases the rate and severity of impaired glucose tolerance later in pregnancy and improves perinatal outcomes. Given the rising rates of obesity and diabetes in this country even among young women and the adverse affects of diabetes of pregnant women and their infants, the investigators feel that it is important to not only identify women at high risk for diabetes early in pregnancy but determine the appropriate management strategy
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With a Diagnosis of Gestational Diabetes at 26 Weeks Gestation. |
19; 23 | 0.32 |
| SECONDARY Number of Participants With Different Modes of Delivery |
11; 17; 26; 19; 0; 1 | 0.32 |
| SECONDARY Number of Participants With Excessive Gestational Weight Gain |
6; 6 | 0.96 |
| SECONDARY Mean Hemoglobin A1C Value at Delivery |
5.5; 5.8 | 0.01 sig |
| SECONDARY Mean Fasting Triglyceride Level |
181; 177.5 | 0.75 |
| SECONDARY Number of Patients With Gestational Hypertension |
3; 3 | 0.95 |
| SECONDARY Number of Patients With Pre-eclampsia |
2; 2 | 0.5 |
| SECONDARY Mean Level of Postpartum Oral Glucose-tolerance-test at 6 Weeks Postpartum |
115.8; 108.9 | 0.6 |
| SECONDARY Number of Participants With Need for Insulin Therapy |
14; 10 | 0.36 |
| SECONDARY Mean Neonatal Birth Weight |
3218; 3322 | 0.42 |
| SECONDARY Mean Ponderal Index |
2.5; 2.5 | 0.5 |
| SECONDARY Mean Level of Umbilical Cord C-peptide >=90th Percentile in the Whole Cohort |
3; 1 | 0.46 |
| SECONDARY Number of Participants With Neonatal Hypoglycemia |
2; 2 | 1 |
| SECONDARY Number of Participants With Neonatal Hyperbilirubinemia |
9; 6 | 0.56 |
| SECONDARY Number of Participants With Intrauterine Fetal Demise |
0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 or older
- Singleton pregnancy
- Prenatal care established at less than 14 weeks
- A1C 5.7-6.4%
- Delivery planned at Lucille Packard Children's Hospital at Stanford University (LPCH) or Santa Clara Valley Medical Center (SVMC)
Exclusion Criteria
- preexisting diabetes or chronic steroid use
- known major fetal anomalies
Data sourced from ClinicalTrials.gov (NCT01552213). 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. Informational only — not medical advice.