Clinical trial NCT03266133: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Keywords: Gestational Diabetes Mellitus
Sleep education
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Glycemic control
timeFrame: 3-6 months during pregnancy
measure: Self-reported sleep duration
timeFrame: 3-6 months during pregnancy
Secondary outcomes:
measure: Average fasting glucose values
timeFrame: 3-6 months during pregnancy
measure: Average postprandial glucose values
timeFrame: 3-6 months during pregnancy
measure: Gestational age at delivery
timeFrame: Time of delivery
measure: Neonatal birth weight
timeFrame: Time of delivery
measure: Indication for delivery
timeFrame: Time of delivery
measure: Route of delivery
timeFrame: Time of delivery
measure: Preeclampsia
timeFrame: Time of delivery
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital of UPMC
state: Pennsylvania
Study officials:
affiliation: Clinical Fellow, Division of Maternal-Fetal Medicine
name: Roxanna Twedt, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.