Sleep Intervention to Improve Glycemic Control in Women With Gestational Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-27

Study Completion Date

2019-06-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Gestational Diabetes Mellitus in Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sleep Education Intervention

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.

Group Type EXPERIMENTAL

Sleep Education for Pregnancy

Intervention Type BEHAVIORAL

Sleep education specific to pregnancy

Routine Care

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sleep Education for Pregnancy

Sleep education specific to pregnancy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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