Sleep Intervention to Improve Glycemic Control in Women With Gestational Diabetes

University of Pittsburgh

Status: Completed

Conditions: Gestational Diabetes Mellitus in Pregnancy

Treatments: Behavioral: Sleep Education for Pregnancy

Study type: Interventional

Funder types: Other

Identifiers

NCT03266133

PRO17050233

Details and patient eligibility

About

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.

Full 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).

Enrollment: 74 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Sleep Education Intervention

Experimental group

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.

Treatment:

Behavioral: Sleep Education for Pregnancy

Routine Care

No Intervention group

Description:

Usual care