Translation and Validation of the French Version of the ObsQoR-10 Questionnaire

NCT04489602 | Unknown

• 1 other identifier: ObsQoR-10F
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Until recently, there was no validated scoring tool to assess recovery after childbirth. Ciechanowicz et al. developed and validated a postpartum recovery score for women with a caesarean section (scheduled or unscheduled): the ObsQoR-11. The psychometric validation of the ObsQoR-11 confirms its reliability, its response to change, its acceptability and its feasibility (average filling time of 2 minutes, and the possibility to print the questionnaire on one page). The use of this score allows the investigators to quantify the quality of the patient's recovery between 0 and 110 (0 being a really poor recovery, and 110 a total recovery), by allocating a score from 0 to 10 for each item. Since then, the initial version of ObsQoR-11 has evolved into a smaller version, ObsQoR-10, for which the pain items have been merged. Similarly, by assigning a score from 0 to 10 for each item, the ObsQoR-10 score allows to quantify the quality of the patient's recovery between 0 and 100 (0 being a very poor recovery, and 100 being full recovery). There are currently no translations of this score into another language, but the investigators can easily assume that they will be done in the near future. French remains the fifth most spoken language in the world. The investigators therefore feel it is necessary to validate the translated version of the ObsQoR-10 score.

Conditions

Delivery; Childbirth; Patient Reported Outcome Measures; Labor Complication; Quality of Recovery

Outcome Measures

Primary Outcomes (1)

• Validity of ObsQoR-10F questionnaire

  Evaluate the validity of the French version of the ObsQoR-10 to assess immediate postpartum recovery (at 24 and 48 hours after vaginal delivery or Caesarean section).

  2 days

Secondary Outcomes (1)

• Validity of ObsQoR-10F questionnaire (Caesarean section)

  2 days

Other Outcomes (2)

• Validity of ObsQoR-10F questionnaire (Vaginal delivery)

  2 days

• Minimal important difference

  2 days

Study Arms (1)

Intervention

Each patient complete ObsQoR-10F questionnaire 3 times (before delivery, on Day 1, on Day 2)

Other: ObsQoR-10F Questionnaire

Interventions

ObsQoR-10F Questionnaire OTHER

The ObsQoR-10F questionnaire consists of 10 items assessing different aspects of postpartum recovery: physical comfort and pain, physical independence and emotional status. It takes two minutes to complete all the items. If the patient is not able to read the questionnaire herself, a third person can ask the questions orally to the patient. If the patient has returned home with her child, she can be contacted by phone to complete the questionnaire. 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients admitted for spontaneous obstetrical labor, induction of obstetrical labor, or scheduled cesarean section.

You may qualify if:

• ≥ 18 years old);
• French-speaking;
• Admitted for spontaneous obstetrical labor, induction of obstetrical labor, or scheduled 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 compromising cooperation in the questionnaire validation protocol,
• Psychological history (medical termination of pregnancy, foetal death in utero).

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

University Hospital of Angers

Angers, 49000, France

RECRUITING

Related Publications (3)

• 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: 30579408 BACKGROUND

• Sultan P, Kormendy F, Nishimura S, Carvalho B, Guo N, Papageorgiou C. Comparison of spontaneous versus operative vaginal delivery using Obstetric Quality of Recovery-10 (ObsQoR-10): An observational cohort study. J Clin Anesth. 2020 Aug;63:109781. doi: 10.1016/j.jclinane.2020.109781. Epub 2020 Mar 20.

  PMID: 32203873 BACKGROUND

• Mazoue E, Veret M, Corroenne R, Mercier MB, Lomo H, Verhaeghe C, Lasocki S, Bouet PE, Leger M. Translation and validation of the French version of the ObsQoR-10 questionnaire for the evaluation of recovery after delivery: the ObsQoR-10-French. BJA Open. 2023 Aug 17;7:100221. doi: 10.1016/j.bjao.2023.100221. eCollection 2023 Sep.

  PMID: 37638079 DERIVED

MeSH Terms

Conditions

Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Maxime Léger, MD

CONTACT

2 41 35 36 35; maxime.leger@chu-angers.fr

Béatrice Gable

CONTACT

2 41 35 68 25; begable@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 28, 2020
• Study Start: February 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: August 1, 2021
• Last Updated: February 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)