Evaluation of Inpatient Sleep and Activity Following Childbirth

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 Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Procedure: planned or unplanned Cesarean, operative, or non operative delivery

• Study Type: Observational
• Enrollment (Actual): 78

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Lucile Packard Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; All types of delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between actigraphy data with inpatient and outpatient postpartum Patient Reported Outcome Measures (PROMs)	Measurement of postpartum actigraphy data to associate with patient reported outcome measures (PROM) (ObsQoR-10, Edinburgh Postpartum Depression Score, WHO-QOL-BREF and Bergen Insomnia Scale Score) given by face to face then remote interview	Day 1-7, 6 and 12 weeks
Association between inpatient actigraphy data and patient demographic, medical, obstetric, psychiatric, neonatal and anesthetic factors	Participants will wear an acitgraphy watch during their inpatient stay to measure physical activity and sleep.	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	Participants will be interviewed at 6 and 12 weeks with PROM questions and sleep diaries to assess for association with demographic, medical obstetric, psychiatric neonatal and anaesthetic factors.	6 and 12 weeks
Association between objective (artigraphy) and subjective sleep assessment using diaries and PROMs	Participants will wear an acitgraphy watch during their inpatient stay to measure physical activity and sleep. PROM survey data during inpatient day 1-7 and outpatient 6- 12 week interview.	Day 1-7, 6 and 12 weeks
Determine population norms of objective and subjective sleep measures in the postpartum population.	Participants will wear an acitgraphy watch during their inpatient stay to measure physical activity and sleep. PROM survey data during inpatient day 1-7 and outpatient 6 and 12 week interview.	Day 1-7, 6 and 12 weeks
Association between inpatient sleep and physical activity, PROMs and peripartum course with longer term outpatient sleep measures	Participants will wear an acitgraphy watch during their inpatient stay to measure physical activity and sleep. PROM survey data during inpatient day 1-7 and outpatient 6 and 12 week interview.	Day 1-7, 6 and 12 weeks

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Pervez Sultan, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: September 22, 2021
• First Posted (Actual): October 1, 2021

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Postpartum sleep
• Other Study ID Numbers: 60762

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

The data collected from the watches will not be available to share with other researchers.

Anonymous and aggregated data will be available for verification only on request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No