Quality of Recovery From Obstetric Anaesthesia - a Multicentre Study

NCT04192045 | Completed

• 1 other identifier: IRAS254064
• Study Type: observational
• Target: 1,638
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstetric Anesthesia Problems; Anesthesia Morbidity; Quality of Life

Outcome Measures

Primary Outcomes (2)

• • 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.

  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.

  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 Outcomes (14)

• • Comparing ObsQoR profiles with differing types of obstetric anaesthesia and delivery method.

  up to 3 months

• • Variations in ObsQoR scores across differing centres.

  up to 3 months

• • Impact of patient factors on ObsQoR score.

  up to 3 months

• • Impact of anaesthetic or obstetric factors on ObsQoR score.

  up to 3 months

• • Impact of neonatal facts on ObsQoR score.

  up to 3 months

Interventions

Survey OTHER

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Female peripartum
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• Stanford University: collaborator

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7RT, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples will be taken from selected Caesarean Delivery Patients before and after delivery to analyse to assess immune profiles.

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Kariem El-Boghdadly

  GSTT

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: December 10, 2019
• Study Start: October 11, 2021
• Primary Completion: October 24, 2021
• Study Completion: November 24, 2021
• Last Updated: June 15, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)