Gestational Diabetes Mellitus in Pregnancy
Conditions
Keywords
Gestational Diabetes Mellitus, Sleep education
Brief summary
This is a pilot randomized controlled trial involving a sleep education intervention in women with gestational diabetes to study whether sleep education during pregnancy leads to improvement in glycemic control in women with gestational diabetes and improvement in sleep duration.
Detailed description
Patients will be identified from the Maternal-Fetal Medicine office and the Perinatal Assessment Clinic at Magee-Womens Hospital, University of Pittsburgh Medical Center. Patients with gestational diabetes will be recruited following general education regarding gestational diabetes in pregnancy which is universally done for all patients at the time of their diagnosis of gestational diabetes. Eligible subjects will be randomized to two groups (usual care vs. sleep education program).
Interventions
BEHAVIORALSleep Education for Pregnancy
Sleep education specific to pregnancy
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Pregnant female 2. Ages 18-50 3. Gestational age between 16 0/7 weeks and 31 6/7 weeks 4. New diagnosis of GDM, not on treatment (i.e., insulin, glyburide, or metformin) at the time of enrollment
Exclusion criteria
1. Children less than 18 years of age 2. Non-English speaking 3. Multiple gestations (twins, triplets, etc)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic control | 3-6 months during pregnancy | Proportion of participants achieving glycemic control at study end. Glycemic control defined as greater than 75% of weeks with average fasting blood glucose \< 95 mg/dL and 1-hr postprandial blood glucose \<140 mg/dL. |
| Self-reported sleep duration | 3-6 months during pregnancy | Proportion of patients who report sleeping between 7-9 hours per night |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gestational age at delivery | Time of delivery | — |
| Neonatal birth weight | Time of delivery | — |
| Average fasting glucose values | 3-6 months during pregnancy | — |
| Route of delivery | Time of delivery | Medical records will be reviewed to determine if the patient had a vaginal delivery or cesarean delivery. |
| Preeclampsia | Time of delivery | Medical records will be reviewed to determine whether a patient had a diagnosis of preeclampsia prior to delivery. |
| Indication for delivery | Time of delivery | Medical records will be used to determine whether a patient when into spontaneous labor, had an induction or labor or a recommended delivery by cesarean section. If the patient had an induction or labor or a recommended cesarean delivery, the indication for this recommendation will be recorded. |
| Average postprandial glucose values | 3-6 months during pregnancy | — |
Countries
United States
Outcome results
None listed