Skip to main content
OpenTrials
Completed

NCT Number: NCT04192045

Quality of Recovery From Obstetric Anaesthesia - a Multicentre Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obstetric Anesthesia Problems Anesthesia Morbidity Quality of Life

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7RT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Survey

Other

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

Primary outcomes

  1. • 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

  2. • 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.

Secondary outcomes

  1. • 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)

  2. • Variations in ObsQoR scores across differing centres.

    Time frame: up to 3 months

    A multicentreed evaluation of the ObsQoR score across multiple centres

  3. • 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

  4. • 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

  5. • 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

  6. • 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

  7. • 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

  8. • 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

  9. • 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

  10. • 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

  11. • 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

  12. • 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.

  13. 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.

  14. 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

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Collaborators

  • Stanford University

Registry information

Acronym: ObsQoR

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 10, 2019
Registry last updated
Jun 15, 2022

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.