Sleep Efficiency and Quantification After Labor Epidural Analgesia

Pregnancy Clinical Trial

— Actiwatch  

Official title:

Sleep Efficiency and Quantification After Labor Epidural Analgesia

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02862951
• Other study ID #: 18682
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 16, 2016
• Last updated: August 8, 2016
• Start date: May 2016
• Est. completion date: December 2016

Study information

• Verified date: August 2016
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 36
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy

Locations

Country	Name	City	State
United States	University of Virginia Health System	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (3)

Hall 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. — View Citation

Skowronski GA. Pain relief in childbirth: changing historical and feminist perspectives. Anaesth Intensive Care. 2015 Jul;43 Suppl:25-8. — View Citation

Wangel AM, Molin J, Ostman M, Jernström 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	efficacy of sleep, automatically derived from the actiwatch device as restlessness during sleep	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	No