Clinical trial NCT05065203: Evaluation of Inpatient Sleep and Activity Following Childbirth
Official title: Evaluation of Inpatient Sleep and Activity Following Childbirth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep
Keywords: Postpartum sleep
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pregnant women booked to deliver their child(ren) at Lucile Packard Children's Hospital. Eligible and consenting patients enrolled will wear an Actigraph watch during their inpatient stay (from preoperative period if undergoing cesarean delivery or during labor if undergoing a planned vaginal delivery).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Assessment of inpatient postpartum sleep using actigraphy
timeFrame: During inpatient stay (up to 7 days)
Secondary outcomes:
measure: Association between actigraphy data with inpatient and outpatient postpartum Patient Reported Outcome Measures (PROMs)
timeFrame: Day 1-7, 6 and 12 weeks
measure: Association between inpatient actigraphy data and patient demographic, medical, obstetric, psychiatric, neonatal and anesthetic factors
timeFrame: During inpatient stay and outpatient follow up (up to 7 days)
measure: Association between outpatient sleep data with patient demographic, medical, obstetric, psychiatric, neonatal and anesthetic factors
timeFrame: 6 and 12 weeks
measure: Association between objective (artigraphy) and subjective sleep assessment using diaries and PROMs
timeFrame: Day 1-7, 6 and 12 weeks
measure: Determine population norms of objective and subjective sleep measures in the postpartum population.
timeFrame: Day 1-7, 6 and 12 weeks
measure: Association between inpatient sleep and physical activity, PROMs and peripartum course with longer term outpatient sleep measures
timeFrame: Day 1-7, 6 and 12 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Lucile Packard Children's Hospital
state: California
Study officials:
affiliation: Stanford University
name: Pervez Sultan, MD
role: PRINCIPAL_INVESTIGATOR
References: