Sleep Intervention to Improve Glycemic Control in Women With Gestational Diabetes

Gestational Diabetes Mellitus in Pregnancy Clinical Trial

Official title:

Sleep Intervention to Improve Glycemic Control in Women With Gestational Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03266133
• Other study ID #: PRO17050233
• Status: Completed
• Phase: N/A
• Start date: November 27, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2019
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus in Pregnancy
• Pregnancy in Diabetics

Intervention

Behavioral:
• Sleep Education for Pregnancy
Sleep education specific to pregnancy

Locations

Country	Name	City	State
United States	Magee-Womens Hospital of UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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):326-31. doi: 10.1097/AOG.0000000000000959. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Self-reported sleep duration	Proportion of patients who report sleeping between 7-9 hours per night	3-6 months during pregnancy
Secondary	Average fasting glucose values		3-6 months during pregnancy
Secondary	Average postprandial glucose values		3-6 months during pregnancy
Secondary	Gestational age at delivery		Time of delivery
Secondary	Neonatal birth weight		Time of delivery
Secondary	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
Secondary	Route of delivery	Medical records will be reviewed to determine if the patient had a vaginal delivery or cesarean delivery.	Time of delivery
Secondary	Preeclampsia	Medical records will be reviewed to determine whether a patient had a diagnosis of preeclampsia prior to delivery.	Time of delivery