Evaluation of Inpatient Sleep and Activity Following Childbirth

Study Overview
=================
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.

Official Title
-----------------
Evaluation of Inpatient Sleep and Activity Following Childbirth

Conditions
-----------------
Sleep

Intervention / Treatment
-----------------
* Procedure: planned or unplanned Cesarean, operative, or non operative delivery


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Postpartum patients<br>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<br>* All types of delivery<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postpartum sleep