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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04729192
Other study ID # ObsQoR-10T
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 5, 2021
Est. completion date October 12, 2021

Study information

Verified date October 2021
Source Konya Meram State Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The quality of recovery scoring tools for the obstetric patient population is limited. In 2019, Ciechanowicz et al. developed and validated a postpartum recovery score; the ObsQoR-11; used following elective and non-elective cesarean delivery. The ObsQoR-11 was modified to the ObsQoR-10 by Sultan et al. and used spontaneous and operative vaginal delivery based on patient feedback. There is currently only a Hebrew version of this recovery score. ObsQoR has not yet been validated for use in Turkish, which is one of the most spoken languages in the World. Therefore the investigators aimed to psychometrically evaluate (assess validity, reliability, and clinical feasibility) the Turkish translated version of the ObsQoR-10 PROM in a Turkish cohort of women.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date October 12, 2021
Est. primary completion date October 12, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 48 Years
Eligibility Inclusion Criteria: - Turkish-speaking women (in Turkey) greater than 18 years of age who are also able to read and understand written Turkish - Spontaneous vaginal delivery with or without neuraxial anesthesia for labor analgesia (including repair of vaginal tears and manual removal of the placenta) or elective cesarean delivery - Women who have singleton births - Primiparous (first baby) -=38 weeks gestational age Exclusion Criteria: - Psychiatric or neurological pathology compromising cooperation in the questionnaire validation protocol, - Age < 18 years - Women whose infants have died - Mother or baby requiring ICU after delivery. - Patient refusal to participate - Inability to read or understand written Turkish - Failed neuraxial analgesia: elective cesarean delivery - General anesthesia - Intrapartum cesarean - Assisted/operative (i.e. vacuum, forceps) vaginal delivery

Study Design


Related Conditions & MeSH terms


Intervention

Other:
ObsQoR-10T Questionnaire
The ObsQoR-10T questionnaire consists of 10 items assessing physical comfort and pain, physical independence, and emotional status. 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.

Locations

Country Name City State
Turkey Betul Kozanhan Konya

Sponsors (1)

Lead Sponsor Collaborator
Konya Meram State Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Validity of Obstetric Quality of Recovery-10 Turkish (ObsQoR-10T) questionnaire Evaluate the validity of the Turkish version of the ObsQoR-10 to assess immediate postpartum recovery following vaginal delivery or Caesarean section.The ObsQoR-10 based on patient feedback regarding the 0-10 scoring for "negative symptoms" such as pain, nausea and vomiting and dizziness (found in questions 1-4 of ObsQoR- 10) and "positive" symptoms such as comfort and feeling in control (found in questions 5-10 of ObsQoR-10). Overall higher recovery scores indicate better recovery. on day 1 following delivery
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