NCT03711552

Brief Summary

The ObsQoR-11 is an 11-item survey that was recently developed to evaluate recovery after caesarean section. This has been shown to be valid, feasible, reliable and responsive to changes in health status. The aim of this study to validate the ObsQoR-11 score in an Irish obstetric hospital. The collection of supplemental data will allow its comparison to the QoR-15 score and calculation of the MCID.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

October 31, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2019

Completed
Last Updated

August 16, 2019

Status Verified

August 1, 2019

Enrollment Period

9 months

First QC Date

October 15, 2018

Last Update Submit

August 15, 2019

Conditions

Quality of RecoveryCaesarean Section

Keywords

CaesareancesareanObsQoR-11QoR-15MCIDminimal clinically important differencequality of recovery

Outcome Measures

Primary Outcomes (1)

  • Validation of ObsQoR-11 in an Irish population.

    Validation of ObsQoR-11 in an Irish population - as per the COSMIN initiative.

    48 hours

Secondary Outcomes (2)

  • Comparison of the the ObsQoR-11 with the QoR-15.

    48 hours

  • Calculation of the MCID of the ObsQoR-11 score.

    48 hours

Study Arms (1)

Quality of recovery

All enrolled patients will be asked to complete the ObsQoR-11 and QoR-15 questionnaires pre-surgery if feasible and at 24 and 48 hours post-surgery.

Other: ObsQoR-11Other: QoR-15

Interventions

ObsQoR-11OTHER

Quality of recovery questionnaire

Quality of recovery
QoR-15OTHER

Quality of recovery questionnaire

Quality of recovery

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant females for caesarean section.

You may qualify if:

  • Caesarean section.
  • Age \>18 years.

You may not qualify if:

  • Inability to read or understand English.
  • Patient refusal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Coombe Women and Infants University Hospital

Dublin, 00000, Ireland

Location

Study Officials

  • Terry Tan

    Head of Department of Anaesthesia CWIUH

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 15, 2018

First Posted

October 18, 2018

Study Start

October 31, 2018

Primary Completion

July 20, 2019

Study Completion

July 20, 2019

Last Updated

August 16, 2019

Record last verified: 2019-08

Locations

IE(1)