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Clinical Trials/NCT05065203
NCT05065203CompletedNot Applicable

Evaluation of Inpatient Sleep and Activity Following Childbirth

Stanford University1 site in 1 country78 target enrollmentStarted: October 21, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
78
Locations
1
Primary Endpoint
Assessment of inpatient postpartum sleep using actigraphy
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Sleep is critical to mental and physical health following childbirth. However, patients who are hospitalized for labor and delivery may be admitted for days with significant impacts on sleep levels. Little is known about sleep and activity levels in inpatients during nighttime and daytime following childbirth and how this may affect their mental and physical health and wellbeing. If abnormalities are identified, targeted interventions may be possible to optimize recovery following delivery.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •over 18 years old
  • •live pregnancy
  • •Single or multiple gestation
  • •all gestational ages

Exclusion Criteria

  • •Weekend delivery
  • •admitted to critical care
  • •unable to speak or understand English
  • •known sleeping disorder
  • •opioid requirement prior to admission
  • •long term steroids use
  • •significant autoimmune or neurological disease
  • •significant psychiatric or neurodevelopment disorder

Outcomes

Primary Outcomes

Assessment of inpatient postpartum sleep using actigraphy

Time Frame: During inpatient stay (up to 7 days)

Participants will wear an acitgraphy watch during their inpatient stay to measure sleep.

Secondary Outcomes

  • Association between inpatient actigraphy data and patient demographic, medical, obstetric, psychiatric, neonatal and anesthetic factors(During inpatient stay and outpatient follow up (up to 7 days))
  • Association between actigraphy data with inpatient and outpatient postpartum Patient Reported Outcome Measures (PROMs)(Day 1-7, 6 and 12 weeks)
  • Association between outpatient sleep data with patient demographic, medical, obstetric, psychiatric, neonatal and anesthetic factors(6 and 12 weeks)
  • Association between objective (artigraphy) and subjective sleep assessment using diaries and PROMs(Day 1-7, 6 and 12 weeks)
  • Determine population norms of objective and subjective sleep measures in the postpartum population.(Day 1-7, 6 and 12 weeks)
  • Association between inpatient sleep and physical activity, PROMs and peripartum course with longer term outpatient sleep measures(Day 1-7, 6 and 12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

PSultan

Associate Professor

Stanford University

Study Sites (1)

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