Sleep Efficiency and Quantification After Labor Epidural Analgesia

• Conditions: Pregnancy

• Registration Number: NCT02862951
• Lead Sponsor: University of Virginia

Brief Summary

The specific aim is to attempt to quantify the amount and efficiency of sleep that parturients receive after placement of labor epidural analgesia.

Detailed Description

The hypothesis is that the placement of labor epidural analgesia results in improved sleep efficiency and increased amount of sleep for parturients during their labor process as measured by an actigraph. An actigraph is a watch that monitors movement and allows for non-invasive determination of sleep-wake cycles. For this study, the Actiwatch 2 will be used due to departmental availability. For this study, 36 parturients will be enrolled that are coming in for induction of labor at term gestational age, regardless of whether they think they will desire epidural analgesia or not . These parturients will wear the Actiwatch from the beginning of induction of their labor until the delivery of their baby. Participants will be instructed to press a button on the watch to record the start and end times of when they are trying to sleep. The data will then be analyzed to determine the amount of time that participants were able to sleep after placement of an epidural catheter as well as their sleep efficiency, defined as the percentage of time spent sleeping during the time in which sleep is attempted.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-06-16
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-08
• Last Update Submitted: 2016-08-08
• Study First Posted: 2016-08-11
• Last Update Posted: 2016-08-11
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

• Parturients admitted for induction of labor
• Term pregnancy (>37 weeks gestational age)

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Exclusion Criteria

• Preterm pregnancy (< 37 weeks gestational age) Parturients not willing or not able to give informed consent Patients receiving magnesium treatment will be excluded.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
amount of sleep as measured by actiwatch device in hours of sleep	after placement of epidural analgesia until delivery	Amount of sleep that parturients receive after placement of labor epidural analgesia.

Secondary Outcome Measures

Name	Time	Method
efficacy of sleep, automatically derived from the actiwatch device as restlessness during sleep	after placement of epidural analgesia until delivery	Sleep efficiency is defined as the percentage of time spent sleeping during the time in which sleep is attempted.

Trial Locations

Locations (1)

University of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States