NCT03266133

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

November 27, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

August 12, 2019

Status Verified

August 1, 2019

Enrollment Period

1.6 years

First QC Date

August 22, 2017

Last Update Submit

August 8, 2019

Conditions

Gestational Diabetes Mellitus in Pregnancy

Keywords

Gestational Diabetes MellitusSleep education

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • 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

    Time of delivery

  • +2 more secondary outcomes

Study Arms (2)

Sleep Education Intervention

EXPERIMENTAL

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

Routine Care

NO INTERVENTION

Usual care

Interventions

Sleep Education for PregnancyBEHAVIORAL

Sleep education specific to pregnancy

Sleep Education Intervention

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Children less than 18 years of age
  • Non-English speaking
  • Multiple gestations (twins, triplets, etc)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (4)

  • 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.

    PMID: 27926645BACKGROUND

  • 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.

    PMID: 26241422BACKGROUND

  • 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.

    PMID: 20510182BACKGROUND

  • 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.

    PMID: 20470416BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Pregnancy

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Roxanna Twedt, MD

    Clinical Fellow, Division of Maternal-Fetal Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Medical Fellow

Study Record Dates

First Submitted

August 22, 2017

First Posted

August 29, 2017

Study Start

November 27, 2017

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

August 12, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)