DeliveryObsQoR-10FNCT04489602
Translation and Validation of the French Version of the ObsQoR-10 Questionnaire
An observational study of Delivery and Childbirth, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Delivery, Childbirth, Patient Reported Outcome Measures
- What is being tested?
- ObsQoR-10F Questionnaire
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2021to Aug 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted for spontaneous obstetrical labor, induction of obstetrical labor, or scheduled cesarean section.
Who may be able to join
- ≥ 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
Who cannot join
- Psychiatric or neurological pathology compromising cooperation in the questionnaire validation protocol,
- Psychological history (medical termination of pregnancy, foetal death in utero).
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital of Angers
Angers, 49000
Maxime Léger, Dr
About this study
Official title: Translation and Validation of the French Version of the ObsQoR-10 Questionnaire for the Evaluation of Recovery After Childbirth: the ObsQoR-10F Questionnaire
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.
Read the detailed description
Recovery after childbirth (by caesarean section or vaginal delivery) is a complex process, depending on the characteristics of the patient, the anaesthesia, and the need for surgery or an instrumental device. This event is a source of stress, anxiety and pain, and can also lead to postpartum complications. Studies evaluating interventions during childbirth traditionally focus on mortality and morbidity which, although important, do not describe the patient's experience or the quality of her recovery.
Scores for measuring the quality of post-operative recovery have been developed. These scoring tools accurately measure post-operative recovery by looking at some dimensions of the patient's experience. However, they have been developed and validated in non-obstetrical patients. They therefore contain aspects of recovery that are not relevant to delivery and postpartum. Furthermore, they do not include key elements, such as the ability to care for the newborn.
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. This multidimensional score is a questionnaire of 11 items evaluating: moderate pain, severe pain, nausea and vomiting, feeling of discomfort, shivering, feeling of comfort, ability to mobilize, ability to carry the newborn, ability to feed, ability to groom alone, and finally feeling of self-control. 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 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.
This tool has the advantage of efficiently evaluating the concept of immediate postpartum recovery, with an acceptable feasibility for both the patient and the caregivers. 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
- Being tested
- ObsQoR-10F Questionnaire
- Medical subject headings
- Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObsQoR-10F QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Each patient complete ObsQoR-10F questionnaire 3 times (before delivery, on Day 1, on Day 2) Receives: Other: ObsQoR-10F Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 days
Secondary outcomes (1)
Validity of ObsQoR-10F questionnaire (Caesarean section)
Ensure the validity of the questionnaire in the sub-population of Caesarean delivery population (scheduled and unscheduled) at 24 and 48 hours
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start1 Feb 2021
- Primary completionJun 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DeliveryStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489602
- Sponsor's protocol ID
- ObsQoR-10F
- Acronym
- ObsQoR-10F
- Status last verified
- Feb 2021
- First submitted
- 23 Jul 2020
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30579408Sultan 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.
PubMed 32203873Mazoue 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.
PubMed 37638079
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Validation of the French Version of the ObsQoR-10 Questionnaire for the Evaluation of Recovery After Childbirth: the ObsQoR-10F Questionnaire
- ClinicalTrials.gov ID
- NCT04489602
- Acronym / sponsor ID
- ObsQoR-10F / ObsQoR-10F
- Conditions
- Delivery, Childbirth, Patient Reported Outcome Measures, Labor Complication, Quality of Recovery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 28 Jul 2020 (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.
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.
Detailed description
Recovery after childbirth (by caesarean section or vaginal delivery) is a complex process, depending on the characteristics of the patient, the anaesthesia, and the need for surgery or an instrumental device. This event is a source of stress, anxiety and pain, and can also lead to postpartum complications. Studies evaluating interventions during childbirth traditionally focus on mortality and morbidity which, although important, do not describe the patient's experience or the quality of her recovery.
Scores for measuring the quality of post-operative recovery have been developed. These scoring tools accurately measure post-operative recovery by looking at some dimensions of the patient's experience. However, they have been developed and validated in non-obstetrical patients. They therefore contain aspects of recovery that are not relevant to delivery and postpartum. Furthermore, they do not include key elements, such as the ability to care for the newborn.
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. This multidimensional score is a questionnaire of 11 items evaluating: moderate pain, severe pain, nausea and vomiting, feeling of discomfort, shivering, feeling of comfort, ability to mobilize, ability to carry the newborn, ability to feed, ability to groom alone, and finally feeling of self-control. 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 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.
This tool has the advantage of efficiently evaluating the concept of immediate postpartum recovery, with an acceptable feasibility for both the patient and the caregivers. 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Other: ObsQoR-10F QuestionnaireEach patient complete ObsQoR-10F questionnaire 3 times (before delivery, on Day 1, on Day 2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted for spontaneous obstetrical labor, induction of obstetrical labor, or scheduled cesarean section.
Key inclusion criteria (5 listed)
- ≥ 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
Key exclusion criteria (2 listed)
- Psychiatric or neurological pathology compromising cooperation in the questionnaire validation protocol,
- Psychological history (medical termination of pregnancy, foetal death in utero).
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 |
|---|---|---|
| ObsQoR-10F QuestionnaireThe 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. | Other | Intervention |
Primary outcome
Validity of ObsQoR-10F questionnaire
Time frame: 2 days
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).
1 secondary outcome
Validity of ObsQoR-10F questionnaire (Caesarean section)
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Background: PubMed 30579408Ciechanowicz 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.
- Background: PubMed 32203873Sultan 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.
- Derived from this study: PubMed 37638079Mazoue 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.
- Individual participant dataSharing planned: No
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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.
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 Delivery and Childbirth, run by University Hospital, Angers at 1 site in France.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Feb 2021. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maxime Léger, MD (2 41 35 36 35 ext. +33, maxime.leger@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of ObsQoR-10F questionnaire (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04489602, which also lists 3 linked publications.
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 Feb 2021.