Sleep Intervention to Improve Glycemic Control in Women With Gestational Diabetes
Primary Purpose
Gestational Diabetes Mellitus in Pregnancy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep Education for Pregnancy
Sponsored by
About this trial
This is an interventional treatment trial for Gestational Diabetes Mellitus in Pregnancy focused on measuring Gestational Diabetes Mellitus, Sleep education
Eligibility Criteria
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)
Sites / Locations
- Magee-Womens Hospital of UPMC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Sleep Education Intervention
Routine Care
Arm Description
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.
Usual care
Outcomes
Primary Outcome Measures
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.
Self-reported sleep duration
Proportion of patients who report sleeping between 7-9 hours per night
Secondary Outcome Measures
Average fasting glucose values
Average postprandial glucose values
Gestational age at delivery
Neonatal birth weight
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.
Route of delivery
Medical records will be reviewed to determine if the patient had a vaginal delivery or cesarean delivery.
Preeclampsia
Medical records will be reviewed to determine whether a patient had a diagnosis of preeclampsia prior to delivery.
Full Information
NCT ID
NCT03266133
First Posted
August 22, 2017
Last Updated
August 8, 2019
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT03266133
Brief Title
Sleep Intervention to Improve Glycemic Control in Women With Gestational Diabetes
Official Title
Sleep Intervention to Improve Glycemic Control in Women With Gestational Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 27, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus in Pregnancy
Keywords
Gestational Diabetes Mellitus, Sleep education
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sleep Education Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine Care
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Sleep Education for Pregnancy
Intervention Description
Sleep education specific to pregnancy
Primary Outcome Measure Information:
Title
Glycemic control
Description
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.
Time Frame
3-6 months during pregnancy
Title
Self-reported sleep duration
Description
Proportion of patients who report sleeping between 7-9 hours per night
Time Frame
3-6 months during pregnancy
Secondary Outcome Measure Information:
Title
Average fasting glucose values
Time Frame
3-6 months during pregnancy
Title
Average postprandial glucose values
Time Frame
3-6 months during pregnancy
Title
Gestational age at delivery
Time Frame
Time of delivery
Title
Neonatal birth weight
Time Frame
Time of delivery
Title
Indication for delivery
Description
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 Frame
Time of delivery
Title
Route of delivery
Description
Medical records will be reviewed to determine if the patient had a vaginal delivery or cesarean delivery.
Time Frame
Time of delivery
Title
Preeclampsia
Description
Medical records will be reviewed to determine whether a patient had a diagnosis of preeclampsia prior to delivery.
Time Frame
Time of delivery
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roxanna Twedt, MD
Organizational Affiliation
Clinical Fellow, Division of Maternal-Fetal Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Magee-Womens Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27926645
Citation
Facco FL, Parker CB, Reddy UM, Silver RM, Koch MA, Louis JM, Basner RC, Chung JH, Nhan-Chang CL, Pien GW, Redline S, Grobman WA, Wing DA, Simhan HN, Haas DM, Mercer BM, Parry S, Mobley D, Hunter S, Saade GR, Schubert FP, Zee PC. Association Between Sleep-Disordered Breathing and Hypertensive Disorders of Pregnancy and Gestational Diabetes Mellitus. Obstet Gynecol. 2017 Jan;129(1):31-41. doi: 10.1097/AOG.0000000000001805.
Results Reference
background
PubMed Identifier
26241422
Citation
Twedt R, Bradley M, Deiseroth D, Althouse A, Facco F. Sleep Duration and Blood Glucose Control in Women With Gestational Diabetes Mellitus. Obstet Gynecol. 2015 Aug;126(2):326-331. doi: 10.1097/AOG.0000000000000959.
Results Reference
background
PubMed Identifier
20510182
Citation
Facco FL, Grobman WA, Kramer J, Ho KH, Zee PC. Self-reported short sleep duration and frequent snoring in pregnancy: impact on glucose metabolism. Am J Obstet Gynecol. 2010 Aug;203(2):142.e1-5. doi: 10.1016/j.ajog.2010.03.041. Epub 2010 May 26.
Results Reference
background
PubMed Identifier
20470416
Citation
Qiu C, Enquobahrie D, Frederick IO, Abetew D, Williams MA. Glucose intolerance and gestational diabetes risk in relation to sleep duration and snoring during pregnancy: a pilot study. BMC Womens Health. 2010 May 14;10:17. doi: 10.1186/1472-6874-10-17.
Results Reference
background
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Sleep Intervention to Improve Glycemic Control in Women With Gestational Diabetes
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