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Completed

NCT Number: NCT03266133

Sleep Intervention to Improve Glycemic Control in Women With Gestational Diabetes

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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Key information

Conditions

Gestational Diabetes Mellitus in Pregnancy Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Sleep Education for Pregnancy

Behavioral

Sleep education specific to pregnancy

Primary outcomes

  1. Glycemic control

    Time frame: 3-6 months during pregnancy

    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.

  2. Self-reported sleep duration

    Time frame: 3-6 months during pregnancy

    Proportion of patients who report sleeping between 7-9 hours per night

Secondary outcomes

  1. Average fasting glucose values

    Time frame: 3-6 months during pregnancy

  2. Average postprandial glucose values

    Time frame: 3-6 months during pregnancy

  3. Gestational age at delivery

    Time frame: Time of delivery

  4. Neonatal birth weight

    Time frame: Time of delivery

  5. Indication for delivery

    Time frame: Time of 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.

  6. Route of delivery

    Time frame: Time of delivery

    Medical records will be reviewed to determine if the patient had a vaginal delivery or cesarean delivery.

  7. Preeclampsia

    Time frame: Time of delivery

    Medical records will be reviewed to determine whether a patient had a diagnosis of preeclampsia prior to delivery.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 29, 2017
Registry last updated
Aug 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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