Sleep Intervention to Improve Glycemic Control in Women With Gestational Diabetes

Not Applicable

Completed

• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Interventions: Behavioral: Sleep Education for Pregnancy

• Registration Number: NCT03266133
• Lead Sponsor: University of Pittsburgh

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).

Study Timeline

• Study First Submitted: 2017-08-22
• Study First Submitted QC: 2017-08-28
• Study First Posted: 2017-08-29
• Study Start: 2017-11-27
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-08
• Last Update Posted: 2019-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 74

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep Education Intervention	Sleep Education for Pregnancy	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Gestational age at delivery	Time of delivery
Average fasting glucose values	3-6 months during pregnancy
Average postprandial glucose values	3-6 months during pregnancy
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.
Neonatal birth weight	Time of delivery
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.

Trial Locations

Locations (1)

Magee-Womens Hospital of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States