Evaluation of Inpatient Sleep and Activity Following Childbirth

Sleep Clinical Trial

Official title:

Evaluation of Inpatient Sleep and Activity Following Childbirth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05065203
• Other study ID #: 60762
• Status: Completed
• Start date: October 21, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: June 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: January 31, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep

Intervention

Procedure:
• planned or unplanned Cesarean, operative, or non operative delivery
All types of delivery

Locations

Country	Name	City	State
United States	Lucile Packard Children's Hospital	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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