Clinical trial NCT04192045: Quality of Recovery From Obstetric Anaesthesia - a Multicentre Study
Official title: Quality of Recovery From Obstetric Anaesthesia - a Multicentre Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstetric Anesthesia Problems
Anesthesia Morbidity
Quality of Life
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2019-12-10
Enrollment: 1638
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Peripartum women during the designated study period who have received anaesthetic intervention in the previous 24-hour period for 3 consecutive days.

Brief summary: Quality of recovery is an important outcome measure in anaesthesia, whilst there are validated tools for this in surgery and regional anesthesia there are no fully validated tools for obstetrics anaesthesia. The aim of this study is to use the Obstetric Quality of Recovery (ObsQoR) score across multiple centres to assess correlation to length of stay and variation for different types of operative and non- operative delivery.

Detailed description: An observational survey based study, for 3 consecutive week days, chosen by the local investigating team during a two-week period across multiple centres.

* Local investigators will complete the survey with each patient who has received anaesthetic intervention from an anaesthetist, 1 day, around 24hrs after delivery in line with their routine anaesthetic follow up.
* At 30 days, a telephone survey will be conducted with each patient to repeat the ObsQoR survey and ask key questions regarding functional recovery and activities of daily living post delivery.

In addition for a small number of sites, elective caesarean delivery patients will have blood taken at the point of anaesthesia and 24 hours post delivery to assess the immune function and any changes which may predict poorer outcome in these women.

Eligibility criteria: Inclusion Criteria:

* Obstetric patients over 18 years old.
* Intervention occurring after 32/40 gestation.
* All mothers receiving anaesthesia or anaesthetic analgesia during their peripartum period.

Exclusion Criteria:

* Unable to comprehend the questions asked
* Patient refusal
* Under 32/40 weeks gestation
* Cervical cerclage insertion or removal, anaesthesia for External Cephalic Verison
* Neonatal death
* Non- NHS patients

Primary outcomes:
measure: • Correlation of ObsQoR with length of hospital stay (LOS) in hours following delivery across multiple centres, particularly ObsQoR score and prediction of prolonged LOS (>1.5 SD) and readmission to hospital.
timeFrame: Up to 3 months
measure: • The relationship between ObsQoR and patient-reported ready for discharge. This will concurrently be determined to account for institutional, non-medical maternal factors neonatal factors that may delay discharge and impact LOS.
timeFrame: up to 3 months
Secondary outcomes:
measure: • Comparing ObsQoR profiles with differing types of obstetric anaesthesia and delivery method.
timeFrame: up to 3 months
measure: • Variations in ObsQoR scores across differing centres.
timeFrame: up to 3 months
measure: • Impact of patient factors on ObsQoR score.
timeFrame: up to 3 months
measure: • Impact of anaesthetic or obstetric factors on ObsQoR score.
timeFrame: up to 3 months
measure: • Impact of neonatal facts on ObsQoR score.
timeFrame: up to 3 months
measure: • Impact of institutional factors on ObsQoR score.
timeFrame: up to 3 months
measure: • Impact of time of day on ObsQoR score.
timeFrame: up to 3 months
measure: • Impact of anaesthesia provider factors on ObsQoR score.
timeFrame: up to 3 months
measure: • Prediction of patients who are likely to have an ongoing requirement for analgesia.
timeFrame: up to 3 months
measure: • Prediction of patients who are likely to require further follow up in the community or investigation.
timeFrame: up to 3 months
measure: • Prediction of patients' ability to return to normal activities of daily living.
timeFrame: up to 3 months
measure: • Prediction of patients' who are unable to achieve adequate activity levels. As determined by number of steps on mobile phone / activity tracker.
timeFrame: up to 3 months
measure: Assessment of perioperative immune function and response to surgical trauma as a predictor of outcome following elective caesarean delivery.
timeFrame: up to 3 months
measure: Assessment of correlation between ObsQoR scores, EQ-5D and global health visual analogue scale results at 24 hours and 30 days.
timeFrame: up to 30 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
Study officials:
affiliation: GSTT
name: Kariem El-Boghdadly
role: STUDY_CHAIR
References: