Obstetric Anesthesia ProblemsObsQoRNCT04192045
Quality of Recovery From Obstetric Anaesthesia - a Multicentre Study
An observational study of Obstetric Anesthesia Problems and Anesthesia Morbidity, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Obstetric Anesthesia Problems, Anesthesia Morbidity, Quality of Life
- What is being tested?
- Survey
- How many people
- 1,638 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Oct 2021to 24 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: Peripartum women during the designated study period who have received anaesthetic intervention in the previous 24-hour period for 3 consecutive days.
Who may be able to join
- Obstetric patients over 18 years old.
- Intervention occurring after 32/40 gestation.
- All mothers receiving anaesthesia or anaesthetic analgesia during their peripartum period.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7RT
About this 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.
Read the 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.
- Being tested
- Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
A survey will be used at 24 hours and 30 days to assess the quality of recovery
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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
Measured: 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.
Measured: up to 3 months
Secondary outcomes (14)
• Comparing ObsQoR profiles with differing types of obstetric anaesthesia and delivery method.
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)
Measured: up to 3 months
• Variations in ObsQoR scores across differing centres.
A multicentreed evaluation of the ObsQoR score across multiple centres
Measured: up to 3 months
• Impact of patient factors on ObsQoR score.
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
Measured: up to 3 months
• Impact of anaesthetic or obstetric factors on ObsQoR score.
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
Measured: up to 3 months
• Impact of neonatal facts on ObsQoR score.
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
Measured: up to 3 months
• Impact of institutional factors on ObsQoR score.
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
Measured: up to 3 months
• Impact of time of day on ObsQoR score.
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
Measured: up to 3 months
• Impact of anaesthesia provider factors on ObsQoR score.
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
Measured: up to 3 months
• Prediction of patients who are likely to have an ongoing requirement for analgesia.
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
Measured: up to 3 months
• Prediction of patients who are likely to require further follow up in the community or investigation.
The patient surgical social and institutional demographics which may predispose some patients to seek healthcare in either the community or hospital setting
Measured: up to 3 months
• Prediction of patients' ability to return to normal activities of daily living.
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
Measured: 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.
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.
Measured: up to 3 months
Assessment of perioperative immune function and response to surgical trauma as a predictor of outcome following elective caesarean delivery.
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.
Measured: 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.
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
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start11 Oct 2021
- Primary completion24 Oct 2021
- Study completion24 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric Anesthesia ProblemsStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,638 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Sponsor
- Investigators
- Kariem El-Boghdadly, Study chair, GSTT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192045
- Sponsor's protocol ID
- IRAS254064
- Acronym
- ObsQoR
- Status last verified
- Jun 2022
- First submitted
- 8 Nov 2019
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The raw data will be available on request at the discretion of the central study team
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Recovery From Obstetric Anaesthesia - a Multicentre Study
- ClinicalTrials.gov ID
- NCT04192045
- Acronym / sponsor ID
- ObsQoR / IRAS254064
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,638 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 24 Oct 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Peripartum women during the designated study period who have received anaesthetic intervention in the previous 24-hour period for 3 consecutive days.
Key inclusion criteria (3 listed)
- Obstetric patients over 18 years old.
- Intervention occurring after 32/40 gestation.
- All mothers receiving anaesthesia or anaesthetic analgesia during their peripartum period.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyA survey will be used at 24 hours and 30 days to assess the quality of recovery | Other | – |
Primary outcome
• 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
• 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.
14 secondary outcomes
• Comparing ObsQoR profiles with differing types of obstetric anaesthesia and delivery method.
Time frame: up to 3 months
• Variations in ObsQoR scores across differing centres.
Time frame: up to 3 months
• Impact of patient factors on ObsQoR score.
Time frame: up to 3 months
• Impact of anaesthetic or obstetric factors on ObsQoR score.
Time frame: up to 3 months
• Impact of neonatal facts on ObsQoR score.
Time frame: up to 3 months
• Impact of institutional factors on ObsQoR score.
Time frame: up to 3 months
• Impact of time of day on ObsQoR score.
Time frame: up to 3 months
• Impact of anaesthesia provider factors on ObsQoR score.
Time frame: up to 3 months
• Prediction of patients who are likely to have an ongoing requirement for analgesia.
Time frame: 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
• Prediction of patients' ability to return to normal activities of daily living.
Time frame: 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 perioperative immune function and response to surgical trauma as a predictor of outcome following elective caesarean delivery.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Individual participant dataSharing planned: No. The raw data will be available on request at the discretion of the central study team
Related trials for Obstetric Anesthesia Problems
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Hyperangulated vs. Macintosh Style Blades for Intubation in Obstetric Patients
Obstetric, Cesarean Birth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kariem El-Boghdadly study chair
GSTT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstetric Anesthesia Problems and Anesthesia Morbidity, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.