Evaluation of Inpatient Sleep and Activity Following Childbirth

NCT05065203 | Completed

• 1 other identifier: 60762
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep

Keywords

Postpartum sleep

Outcome Measures

Primary Outcomes (1)

• Assessment of inpatient postpartum sleep using actigraphy

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

  During inpatient stay (up to 7 days)

Secondary Outcomes (6)

• Association between actigraphy data with inpatient and outpatient postpartum Patient Reported Outcome Measures (PROMs)

  Day 1-7, 6 and 12 weeks

• 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 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

Study Arms (1)

Postpartum patients

Women booked and have delivery of their child(ren) at Lucile Packard Children's Hospital

Procedure: planned or unplanned Cesarean, operative, or non operative delivery

Interventions

planned or unplanned Cesarean, operative, or non operative delivery PROCEDURE

All types of delivery

Postpartum patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital

Stanford, California, 94305, United States

Location

Study Officials

• Pervez Sultan, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 1, 2021
• Study Start: October 21, 2021
• Primary Completion: September 30, 2022
• Study Completion: January 31, 2023
• Last Updated: June 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)