Evaluation of Inpatient Sleep and Activity Following Childbirth

Sponsor
Stanford University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05065203
Collaborator
(none)
60
1
13.3
4.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: planned or unplanned Cesarean, operative, or non operative delivery

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of Inpatient Sleep and Activity Following Childbirth
Actual Study Start Date :
Oct 21, 2021
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Nov 30, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Assessment of inpatient postpartum sleep using actigraphy [During inpatient stay (up to 7 days)]

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

Secondary Outcome Measures

  1. Association between actigraphy data with inpatient and outpatient postpartum Patient Reported Outcome Measures (PROMs) [Day 1-7, 6 and 12 weeks]

    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

  2. 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)]

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

  3. Association between outpatient sleep data with patient demographic, medical, obstetric, psychiatric, neonatal and anesthetic factors [6 and 12 weeks]

    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.

  4. Association between objective (artigraphy) and subjective sleep assessment using diaries and PROMs [Day 1-7, 6 and 12 weeks]

    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.

  5. Determine population norms of objective and subjective sleep measures in the postpartum population. [Day 1-7, 6 and 12 weeks]

    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.

  6. Association between inpatient sleep and physical activity, PROMs and peripartum course with longer term outpatient sleep measures [Day 1-7, 6 and 12 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lucile Packard Children's Hospital Stanford California United States 94305

Sponsors and Collaborators

  • Stanford University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
PSultan, Associate Professor, Stanford University
ClinicalTrials.gov Identifier:
NCT05065203
Other Study ID Numbers:
  • 60762
First Posted:
Oct 1, 2021
Last Update Posted:
Apr 26, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by PSultan, Associate Professor, Stanford University

Study Results

No Results Posted as of Apr 26, 2022