Sleep Efficiency and Quantification After Labor Epidural Analgesia (Actiwatch)

August 8, 2016 updated by: Mohamed Tiouririne, MD, University of Virginia
The specific aim is to attempt to quantify the amount and efficiency of sleep that parturients receive after placement of labor epidural analgesia.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Parturients admitted for induction of labor

-Term pregnancy (>37 weeks gestational age)

Description

Inclusion Criteria:

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Term pregnancy (>37 weeks gestation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
amount of sleep as measured by actiwatch device in hours of sleep
Time Frame: after placement of epidural analgesia until delivery
Amount of sleep that parturients receive after placement of labor epidural analgesia.
after placement of epidural analgesia until delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy of sleep, automatically derived from the actiwatch device as restlessness during sleep
Time Frame: 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.
after placement of epidural analgesia until delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Tiouririne Mohamed, MD, University of Virginia Dept of Anesthesiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

June 16, 2016

First Submitted That Met QC Criteria

August 8, 2016

First Posted (Estimate)

August 11, 2016

Study Record Updates

Last Update Posted (Estimate)

August 11, 2016

Last Update Submitted That Met QC Criteria

August 8, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 18682

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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