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OpenTrials
Completed

NCT Number: NCT05065203

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.

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Key information

Conditions

Sleep

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Lucile Packard Children's Hospital

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

planned or unplanned Cesarean, operative, or non operative delivery

Procedure

All types of delivery

Primary outcomes

  1. Assessment of inpatient postpartum sleep using actigraphy

    Time frame: During inpatient stay (up to 7 days)

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

Secondary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Oct 1, 2021
Registry last updated
Jun 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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