PregnancyActiwatchNCT02862951
Sleep Efficiency and Quantification After Labor Epidural Analgesia
An observational study of Pregnancy, run by University of Virginia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Parturients admitted for induction of labor -Term pregnancy (>37 weeks gestational age)
Who may be able to join
- Parturients admitted for induction of labor
- Term pregnancy (>37 weeks gestational age)
Who cannot join
- Preterm pregnancy (< 37 weeks gestational age) Parturients not willing or not able to give informed consent Patients receiving magnesium treatment will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
The specific aim is to attempt to quantify the amount and efficiency of sleep that parturients receive after placement of labor epidural analgesia.
Read the 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.
- Conditions
- Pregnancy
- Keywords
- pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Term pregnancy (>37 weeks gestation) | Term pregnancy (>37 weeks gestation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of sleep as measured by actiwatch device in hours of sleep
Amount of sleep that parturients receive after placement of labor epidural analgesia.
Measured: after placement of epidural analgesia until delivery
Secondary outcomes (1)
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.
Measured: after placement of epidural analgesia until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Tiouririne, MD, University of Virginia
- Investigators
- Tiouririne Mohamed, MD, Principal investigator, University of Virginia Dept of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862951
- Sponsor's protocol ID
- 18682
- Acronym
- Actiwatch
- Status last verified
- Aug 2016
- First submitted
- 16 Jun 2016
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Skowronski GA. Pain relief in childbirth: changing historical and feminist perspectives. Anaesth Intensive Care. 2015 Jul;43 Suppl:25-8. doi: 10.1177/0310057X150430S106.
PubMed 26126073Hall 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.
PubMed 22862846Wangel 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.
PubMed 21306317
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Efficiency and Quantification After Labor Epidural Analgesia
- ClinicalTrials.gov ID
- NCT02862951
- Acronym / sponsor ID
- Actiwatch / 18682
- Conditions
- Pregnancy
- Keywords
- pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Term pregnancy (>37 weeks gestation) | – | –Term pregnancy (>37 weeks gestation) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Parturients admitted for induction of labor -Term pregnancy (>37 weeks gestational age)
Key inclusion criteria (2 listed)
- Parturients admitted for induction of labor
- Term pregnancy (>37 weeks gestational age)
Key exclusion criteria (1 listed)
- Preterm pregnancy (< 37 weeks gestational age) Parturients not willing or not able to give informed consent Patients receiving magnesium treatment will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
efficacy of sleep, automatically derived from the actiwatch device as restlessness during sleep
Time frame: after placement of epidural analgesia until delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
- Background: PubMed 26126073Skowronski GA. Pain relief in childbirth: changing historical and feminist perspectives. Anaesth Intensive Care. 2015 Jul;43 Suppl:25-8. doi: 10.1177/0310057X150430S106.
- Background: PubMed 22862846Hall 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.
- Background: PubMed 21306317Wangel 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.
- Individual participant dataSharing planned: No
Related trials for Pregnancy
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Active, not recruitingPhase 2
Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation
Muscle-Invasive Bladder Carcinoma, Programmed Cell Death Protein 1 Inhibitor
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
RecruitingPhase 2
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Chronic Kidney Disease
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiouririne Mohamed, MD principal investigator
University of Virginia Dept of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of sleep as measured by actiwatch device in hours of sleep (time frame: after placement of epidural analgesia until delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02862951, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2016.