Sleep Efficiency and Quantification After Labor Epidural Analgesia
Actiwatch
1 other identifier
observational
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2016
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 16, 2016
CompletedFirst Posted
Study publicly available on registry
August 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedAugust 11, 2016
August 1, 2016
7 months
June 16, 2016
August 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
amount of sleep as measured by actiwatch device in hours of sleep
Amount of sleep that parturients receive after placement of labor epidural analgesia.
after placement of epidural analgesia until delivery
Secondary Outcomes (1)
efficacy of sleep, automatically derived from the actiwatch device as restlessness during sleep
after placement of epidural analgesia until delivery
Study Arms (1)
Term pregnancy (>37 weeks gestation)
Term pregnancy (\>37 weeks gestation)
Eligibility Criteria
Parturients admitted for induction of labor -Term pregnancy (\>37 weeks gestational age)
You may qualify if:
- Parturients admitted for induction of labor
- Term pregnancy (\>37 weeks gestational age)
You may not qualify if:
- Preterm pregnancy (\< 37 weeks gestational age) Parturients not willing or not able to give informed consent Patients receiving magnesium treatment will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Related Publications (3)
Skowronski GA. Pain relief in childbirth: changing historical and feminist perspectives. Anaesth Intensive Care. 2015 Jul;43 Suppl:25-8. doi: 10.1177/0310057X150430S106.
PMID: 26126073BACKGROUNDHall WA, Stoll K, Hutton EK, Brown H. A prospective study of effects of psychological factors and sleep on obstetric interventions, mode of birth, and neonatal outcomes among low-risk British Columbian women. BMC Pregnancy Childbirth. 2012 Aug 3;12:78. doi: 10.1186/1471-2393-12-78.
PMID: 22862846BACKGROUNDWangel AM, Molin J, Ostman M, Jernstrom H. Emergency cesarean sections can be predicted by markers for stress, worry and sleep disturbances in first-time mothers. Acta Obstet Gynecol Scand. 2011 Mar;90(3):238-44. doi: 10.1111/j.1600-0412.2010.01056.x. Epub 2011 Feb 3.
PMID: 21306317BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Tiouririne Mohamed, MD
University of Virginia Dept of Anesthesiology
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesiology attending
Study Record Dates
First Submitted
June 16, 2016
First Posted
August 11, 2016
Study Start
May 1, 2016
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
August 11, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share