Quality of Recovery From Obstetric Anaesthesia - a Multicentre Study (ObsQoR)

June 14, 2022 updated by: Guy's and St Thomas' NHS Foundation Trust
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1638

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 7RT
        • Guy's and St Thomas' NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
• 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.
Time Frame: Up to 3 months
During the study the total length of stay in hours will be calculated for participating patients. This will be correlated with the score from the ObsQoR survey tool. In addition the readmission status of the patient will be asked at the subsequent survey combined with the patient's health care record to correlate with the ObsQoR tool score. Where the ObsQoR score is measured between 0-100 and LOS will be in hours. Readmission will be a binary outcome measure
Up to 3 months
• 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.
Time Frame: up to 3 months
The patient will be surveyed using the ObsQoR tool and also asked regarding when they felt they were ready for discharge to take into account the multitude of factors which may impact on the overall length of stay. Where the ObsQoR score is measured between 0-100 and LOS will be in hours.
up to 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
• Comparing ObsQoR profiles with differing types of obstetric anaesthesia and delivery method.
Time Frame: up to 3 months
ObsQoR tool will be used to assess the quality of recovery from General anaesthesia and differing types of regional anaesthesia (Spinal, Epidural, Dural puncture epidural (DPE) and combined spinal and epidural (CSE)
up to 3 months
• Variations in ObsQoR scores across differing centres.
Time Frame: up to 3 months
A multicentreed evaluation of the ObsQoR score across multiple centres
up to 3 months
• Impact of patient factors on ObsQoR score.
Time Frame: up to 3 months
A large number of variables will affect the quality of recovery and the ObsQoR score, these factors will be assessed. Where the ObsQoR score is measured between 0-100
up to 3 months
• Impact of anaesthetic or obstetric factors on ObsQoR score.
Time Frame: up to 3 months
A large number of variables will affect the quality of recovery and the ObsQoR score, these factors will be assessed. Where the ObsQoR score is measured between 0-100
up to 3 months
• Impact of neonatal facts on ObsQoR score.
Time Frame: up to 3 months
A large number of variables will affect the quality of recovery and the ObsQoR score, these factors will be assessed. Where the ObsQoR score is measured between 0-100
up to 3 months
• Impact of institutional factors on ObsQoR score.
Time Frame: up to 3 months
Differing centres will have differing institutional setup, guidelines, staffing levels, these will be assessed related to ObsQoR scores. Where the ObsQoR score is measured between 0-100
up to 3 months
• Impact of time of day on ObsQoR score.
Time Frame: up to 3 months
Time of day may impact on patient care on the quality of recover and the ObsQoR score- these will both be assessed. Where the ObsQoR score is measured between 0-100
up to 3 months
• Impact of anaesthesia provider factors on ObsQoR score.
Time Frame: up to 3 months
The level of seniority of anaesthesia provider may impact on the quality of recover and the ObsQoR score- these will both be assessed. Where the ObsQoR score is measured between 0-100
up to 3 months
• Prediction of patients who are likely to have an ongoing requirement for analgesia.
Time Frame: up to 3 months
The varying delivery methods have differing requirements for analgesia, it is not currently known the impact and effect this has on the quality of recovery. Where the ObsQoR score is measured between 0-100
up to 3 months
• Prediction of patients who are likely to require further follow up in the community or investigation.
Time Frame: up to 3 months
The patient surgical social and institutional demographics which may predispose some patients to seek healthcare in either the community or hospital setting
up to 3 months
• Prediction of patients' ability to return to normal activities of daily living.
Time Frame: up to 3 months
Functional recovery will be assessed observing return to normal activities of daily living (ADLs) and compared to ObsQoR score for patients of all delivery types. The score of ADLs will be correlated to ObsQoR score Where the ObsQoR score is measured between 0-100
up to 3 months
• Prediction of patients' who are unable to achieve adequate activity levels. As determined by number of steps on mobile phone / activity tracker.
Time Frame: up to 3 months
Assessment of the number of steps and related to quality of recovery and return to normal activities of daily living. Where steps will be a continuous measure and ObsQoR score will be measured from 0-100.
up to 3 months
Assessment of perioperative immune function and response to surgical trauma as a predictor of outcome following elective caesarean delivery.
Time Frame: up to 3 months
this will be assessed by taking bloods at the point of anaesthesia and 24 hours post in selected patients undergoing a elective caesarean delivery. The samples will then be analysed to assess the immune response.
up to 3 months
Assessment of correlation between ObsQoR scores, EQ-5D and global health visual analogue scale results at 24 hours and 30 days.
Time Frame: up to 30 days
Assessment of the relationship between ObsQoR scores at 24 hours with EQ-5D and global VAS scores at 24 hours and 30 days between different patients modes of anaesthesia, delivery types and institutions. Assessment of the relationship patient reported outcome measures PROMs to objective poor recovery such as, length of stay, complications and readmissions
up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guy's and St Thomas' NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Stanford University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Kariem El-Boghdadly, GSTT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 24, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 24, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRAS254064

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The raw data will be available on request at the discretion of the central study team

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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