Quality of Recovery From Obstetric Anaesthesia - a Multicentre Study

NCT ID: NCT04192045

Last Updated: 2022-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1638 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-11

Study Completion Date

2021-11-24

Brief Summary

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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

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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.

Conditions

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Obstetric Anesthesia Problems Anesthesia Morbidity Quality of Life

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Survey

A survey will be used at 24 hours and 30 days to assess the quality of recovery

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kariem El-Boghdadly

Role: STUDY_CHAIR

GSTT

Locations

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Guy's and St Thomas' NHS Foundation Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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IRAS254064

Identifier Type: -

Identifier Source: org_study_id

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