NCT04744311

Brief Summary

Ciechanowicz et al. developed and validated a postpartum recovery score for women with a caesarean section: the ObsQoR-11. The psychometric validation of the ObsQoR-11 confirms its reliability, its response to change, its acceptability and its feasibility. The use of this score allows the investigators to quantify the quality of the patient's recovery between 0 and 110, by allocating a score from 0 to 10 for each item. ObsQoR-11 has not yet been validated for use in Turkish. Therefore the investigators aimed to psychometrically evaluate the Turkish translated version of the ObsQoR-11 in a Turkish cohort of women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2021

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 1, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

February 1, 2021

Last Update Submit

February 19, 2023

Conditions

Keywords

Questionnaire Obstetric Quality-of-recovery 11 (ObsQoR-11T)

Outcome Measures

Primary Outcomes (1)

  • Validity of ObsQoR-11T questionnaire

    Evaluate the validity of the Turkish version of the ObsQoR-11 to assess postoperative recovery

    At 24 hours after caesarean section

Interventions

The ObsQoR-11T questionnaire consists of 11 items assessing different aspects of postpartum recovery: physical comfort and pain, physical independence and emotional status. If the patient is not able to read the questionnaire herself, a third person can ask the questions orally to the patient. Each item is scored from 0 to 10 and the total score is the sum of the score for each item, which is a score from 0 to 110.

Eligibility Criteria

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

All patients admitted for cesarean section

You may qualify if:

  • ≥ 18 years old)
  • Turkish-speaking
  • Admitted for cesarean section
  • Able to answer the questionnaire, alone or with the help of a third party
  • Agreeing to participate in the study

You may not qualify if:

  • Psychiatric or neurological pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SBÜ Gülhane Education and Training Hospital

Etlik, Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (2)

  • Ciechanowicz S, Setty T, Robson E, Sathasivam C, Chazapis M, Dick J, Carvalho B, Sultan P. Development and evaluation of an obstetric quality-of-recovery score (ObsQoR-11) after elective Caesarean delivery. Br J Anaesth. 2019 Jan;122(1):69-78. doi: 10.1016/j.bja.2018.06.011. Epub 2018 Jul 31.

    PMID: 30579408BACKGROUND
  • Ciechanowicz S, Howle R, Heppolette C, Nakhjavani B, Carvalho B, Sultan P. Evaluation of the Obstetric Quality-of-Recovery score (ObsQoR-11) following non-elective caesarean delivery. Int J Obstet Anesth. 2019 Aug;39:51-59. doi: 10.1016/j.ijoa.2019.01.010. Epub 2019 Feb 2.

    PMID: 30885691BACKGROUND

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

February 1, 2021

First Posted

February 8, 2021

Study Start

January 20, 2021

Primary Completion

July 20, 2021

Study Completion

September 30, 2021

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations