Sleep Intervention to Improve Glycemic Control in Women With Gestational Diabetes

Study Overview
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Brief Summary
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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
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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).

Official Title
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Sleep Intervention to Improve Glycemic Control in Women With Gestational Diabetes

Conditions
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Gestational Diabetes Mellitus in Pregnancy

Intervention / Treatment
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* Behavioral: Sleep Education for Pregnancy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant female Ages 18-50 Gestational age between 16 0/7 weeks and 31 6/7 weeks New diagnosis of GDM, not on treatment (i.e., insulin, glyburide, or metformin) at the time of enrollment Exclusion Criteria: Children less than 18 years of age Non-English speaking Multiple gestations (twins, triplets, etc)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep Education Intervention<br>This is a two-session program designed to educate patients about healthy sleep in respect to timing, regularity, efficiency, and duration in order to promote sleep during pregnancy. | Behavioral: Sleep Education for Pregnancy<br>* Sleep education specific to pregnancy<br>|
| No Intervention: Routine Care<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control | 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. | 3-6 months during pregnancy | 
| Self-reported sleep duration | Proportion of patients who report sleeping between 7-9 hours per night | 3-6 months during pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average fasting glucose values |  | 3-6 months during pregnancy | 
| Average postprandial glucose values |  | 3-6 months during pregnancy | 
| Gestational age at delivery |  | Time of delivery | 
| Neonatal birth weight |  | Time of delivery | 
| Indication for 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. | Time of delivery | 
| Route of delivery | Medical records will be reviewed to determine if the patient had a vaginal delivery or cesarean delivery. | Time of delivery | 
| Preeclampsia | Medical records will be reviewed to determine whether a patient had a diagnosis of preeclampsia prior to delivery. | Time of delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gestational Diabetes Mellitus, Sleep education