Failed VBAC (Vaginal Birth After Cesarean)ObsQoR-11NCT05373563
Quality of Postpartum Cesarean Recovery Score Validity Reliability
An observational study of Failed VBAC (Vaginal Birth After Cesarean), run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
In order to provide the best care of patients after cesarean section, to help solve all their biopsychosocial problems in the recovery process, and to shorten the hospitalization period, it should be measured with appropriate measurement tools for various evaluations. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Failed VBAC (Vaginal Birth After Cesarean)
- What is being tested?
- cesarean section women
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jul 2022to 2 Oct 2022
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Study study of 18 patients using large cesarean section.
Who may be able to join
- Must be Over 18 age,
- Must be literate women,
- Must be no neurological disease
Who cannot join
- Must be unwilling to participate in the study
- Must be under 18 years old women
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun Health Directorate
Samsun, Black Sea, 55060
About this study
In order to provide the best care of patients after cesarean section, to help solve all their biopsychosocial problems in the recovery process, and to shorten the hospitalization period, it should be measured with appropriate measurement tools for various evaluations. The Scale of Post-cesarean Healing Quality You will provide in adapting the ObsQoR-11 questionnaire to Turkish.
Read the detailed description
In order to provide the best care of patients after cesarean section, to help solve all their biopsychosocial problems in the recovery process, and to shorten the hospitalization period, it should be measured with appropriate measurement tools for various evaluations. We will provide the Scale of Post-Cesarean Healing Quality in adapting the ObsQoR-11 questionnaire to Turkish.It is important to define well the recovery after cesarean section.
- Being tested
- cesarean section women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cesarean section womenProcedure or surgery
The test will be applied to women who have had a cesarean section and the Turkish validity and reliability of the scale will be determined according to the answers given.
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Postpartum Cesarean Recovery Score validity reliability
Measuring early recovery after cesarean section
Measured: July 2022-October 2022
obstetric qualityof- recovery score (ObsQoR-11)
Women were approached while in the postnatal ward 24 h after CS and asked to complete the ObsQoR-11K questionnaire and to choose a point in the 100-mm numeric rating scale (NRS) to evaluate global health status. Women rated each recovery item using an 11-point numerical Likert scale (0 = strongly negative; 10 = strongly positive).
Global health status was measured using NRS indicated by a 100 mm line (0 = 'worst imaginable health status' and 'sad' face; 100 = 'best imaginable health status' and 'happy' face).
Measured: About six mount
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start24 Jul 2022
- Primary completion5 Sep 2022
- Study completion2 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failed VBAC (Vaginal Birth After Cesarean)Studies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe 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
- Cross-sectional
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ümmühan kılıç, Ondokuz Mayıs University
- Investigators
- Dilek Kıymaz,, PhD, Principal investigator, Samsun Provincial Health DirectorateEsra Saraçoğlu, PhD, Study chair, Samsun Provincial Health Directorate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373563
- Sponsor's protocol ID
- SAMSUN HEALTH DİRECTORATE
- Acronym
- ObsQoR-11
- Status last verified
- Jan 2023
- First submitted
- 22 Apr 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Postpartum Cesarean Recovery Score Validity Reliability
- ClinicalTrials.gov ID
- NCT05373563
- Acronym / sponsor ID
- ObsQoR-11 / SAMSUN HEALTH DİRECTORATE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 24 Jul 2022 (actual)
- Primary completion
- 5 Sep 2022 (actual)
- Study completion
- 2 Oct 2022 (actual)
- First posted
- 13 May 2022 (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.
In order to provide the best care of patients after cesarean section, to help solve all their biopsychosocial problems in the recovery process, and to shorten the hospitalization period, it should be measured with appropriate measurement tools for various evaluations. The Scale of Post-cesarean Healing Quality You will provide in adapting the ObsQoR-11 questionnaire to Turkish.
Detailed description
In order to provide the best care of patients after cesarean section, to help solve all their biopsychosocial problems in the recovery process, and to shorten the hospitalization period, it should be measured with appropriate measurement tools for various evaluations. We will provide the Scale of Post-Cesarean Healing Quality in adapting the ObsQoR-11 questionnaire to Turkish.It is important to define well the recovery after cesarean section.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Study study of 18 patients using large cesarean section.
Key inclusion criteria (3 listed)
- Must be Over 18 age,
- Must be literate women,
- Must be no neurological disease
Key exclusion criteria (2 listed)
- Must be unwilling to participate in the study
- Must be under 18 years old women
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 |
|---|---|---|
| cesarean section womenThe test will be applied to women who have had a cesarean section and the Turkish validity and reliability of the scale will be determined according to the answers given. | Procedure or surgery | – |
Primary outcome
Quality of Postpartum Cesarean Recovery Score validity reliability
Time frame: July 2022-October 2022
Measuring early recovery after cesarean section
obstetric qualityof- recovery score (ObsQoR-11)
Time frame: About six mount
Women were approached while in the postnatal ward 24 h after CS and asked to complete the ObsQoR-11K questionnaire and to choose a point in the 100-mm numeric rating scale (NRS) to evaluate global health status. Women rated each recovery item using an 11-point numerical Likert scale (0 = strongly negative; 10 = strongly positive). Global health status was measured using NRS indicated by a 100 mm line (0 = 'worst imaginable health status' and 'sad' face; 100 = 'best imaginable health status' and 'happy' face).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Individual participant dataSharing planned: No
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.
Dilek Kıymaz,, PhD principal investigator
Samsun Provincial Health Directorate
Esra Saraçoğlu, PhD study chair
Samsun Provincial Health Directorate
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 Failed VBAC (Vaginal Birth After Cesarean), run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 26 Jan 2023. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Postpartum Cesarean Recovery Score validity reliability (time frame: July 2022-October 2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2023.