Quality of LifeNCT05704179
Evaluation of the Relationship Between Obstetric Comorbidity Index and Obstetric Quality of Recovery Score
An observational study of Quality of Life and Obstetric Complication, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial summary
The goal of this prospective observational study is to learn about the correlation between obstetric comorbidity index and obstetric quality of recovery score in pregnant patients who undergo cesarean section. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Obstetric Complication, Cesarean Section Complications
- What is being tested?
- Obstetric Quality of recovery score
- How many people
- 214 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2023to 20 Mar 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Turkish or English-speaking, >18 years old, pregnant patients who undergo cesarean section will be included in the study.
Who may be able to join
- Pregnant women who are admitted for Cesarean section > 18 years old
- Speaking Turkish or English
- Agreeing to participate in the study
Who cannot join
- Pregnant women < 18 years old
- Can not speak Turkish or English
- Not agreeing to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Taşçıoğlu Training and Research Hospital
Istanbul, 0 (538) 314-55-
About this study
Official title: Evaluation of the Relationship Between Obstetric Comorbidity Index and Obstetric Recovery Quality Score in Patients Who Undergo Operative Delivery
The goal of this prospective observational study is to learn about the correlation between obstetric comorbidity index and obstetric quality of recovery score in pregnant patients who undergo cesarean section. The main question aims to answer are:
- Are there a correlation between the obstetric comorbidity index and the obstetric quality of recovery score? Can we predict the postoperative quality of recovery by calculating the obstetric comorbidity index before delivery?
- What is the relationship between these scores with the type of anaesthesia given? Participants will answer an 11-question assessment scale to evaluate their recovery of quality in the postpartum period.
Read the detailed description
After the approval of the ethics committee and the written informed consent of the patients, the patients who are meeting the criteria of inclusion will be included in the study. The demographic data, type of anaesthesia, intraoperative haemorrhage, length of hospital stay and intensive care unit stay(if applicable), the urgency category of the cesarean section, and complications will be recorded. patients will be evaluated with obstetric quality of recovery assessment score on postpartum 1st and 2nd days
- Conditions
- Quality of Life, Obstetric Complication, Cesarean Section Complications, Comorbidities and Coexisting Conditions, Obstetric Anesthesia Problems
- Being tested
- Obstetric Quality of recovery score
- Keywords
- Obstetric comorbidity index, Obstetric Quality of Recovery, Cesarean section, Obstetric Anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obstetric Quality of recovery scoreOther
Patients' quality of recovery will be evaluated with Obstetric Quality of recovery score (ObsQoR-11) on postpartum day 1 and day 2.
| Study group | Role | What they receive |
|---|---|---|
| Patients who undergo cesarean section | Obstetric comorbidity index will be calculated for all patients, obstetric quality of recovery score will be evaluated in postpartum period( on the first and second day postpartum) Receives: Other: Obstetric Quality of recovery score |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between Obstetric comorbidity index (OBCMI) and Obstetric Quality of Recovery score(ObsQoR-11) on postpartum 1st day
Obstetric comorbidity index will be calculated before c-section.ObsQoR-11 Questionnaire will be done postoperatively.
Measured: each patient will be evaluated on postpartum 1st day
The correlation between Obstetric comorbidity index (OBCMI) and Obstetric Quality of Recovery score(ObsQoR-11) on postpartum 2nd day
Obstetric comorbidity index will be calculated before c-section.ObsQoR-11 Questionnaire will be done postoperatively.
Measured: each patient will be evaluated on postpartum 2nd day
Secondary outcomes (20)
Evaluation of the relationship between type of anaesthesia and OBCMI
Type of anaethesia will be recorded from the anaesthesia follow-up sheats. Obstetric comorbidity index will be calculated before c-section.
Measured: each patient will be evaluated on the day of c-section
The relation between Lenght of hospital stay and ObsQoR-11 score on postpartum 1st day
Lenght of hospital stay will be recorded from hospital software.ObsQoR-11 will be evaluated on postpartum 1st day
Measured: 2months
The relation between Lenght of hospital stay and ObsQoR-11 score on postpartum 2nd day
Lenght of hospital stay will be recorded from hospital software. ObsQoR-11 will be evaluated on postpartum 2nd day
Measured: 2months
The relation between complications and OBCMI
Complications will be recorded.
Measured: 2months
The relation between complications and ObsQoR-11 on postpartum 1st day
Complications will be recorded
Measured: 2months
The relation between complications and ObsQoR-11 on postpartum 2nd day
Complications will be recorded
Measured: 2months
The relation between urgency of cesarean section and OBCMI
C-section category will be evaluated
Measured: each patient will be evaluated on the day of c-section
The relation between urgency of cesarean section and ObsQoR-11 score on postpartum 1st day
C-section category will be evaluated
Measured: each patient will be evaluated on the day of c-section
The relation between urgency of cesarean section and ObsQoR-11 score on postpartum 2nd day
C-section category will be evaluated
Measured: each patient will be evaluated on the day of c-section
The relation between intraoperative hemorrhage and OBCMI
Instraoperative hemorrhage will be recorded from the anaesthesia follow-up sheats.
Measured: On the day of C-section
The relation between intraoperative hemorrhage and ObsQoR-11 score on postpartum 1st day
Instraoperative hemorrhage will be recorded from the anaesthesia follow-up sheats.
Measured: On the day of C-section
The relation between intraoperative hemorrhage and ObsQoR-11 score on postpartum 2nd day
Instraoperative hemorrhage will be recorded from the anaesthesia follow-up sheats.
Measured: The first 2 days postpartum
The relation between postoperative intensive care unit stay and OBCMI
Postoperative intensive care unit need and lenght of stay will be recorded
Measured: each patient will be evaluated on the day of c-section
The relation between postoperative intensive care unit stay and ObsQoR-11 score on 1st day
Postoperative intensive care unit need and lenght of stay will be recorded.
Measured: each patient will be evaluated on postpartum 1st day
The relation between postoperative intensive care unit stay and ObsQoR-11 score on 2nd day
Postoperative intensive care unit need and lenght of stay will be recorded.
Measured: each patient will be evaluated on postpartum 2nd day
Demographic data, previous obstetric history and their relation with OBCMI
Demographic data and previous obstetric history will be recorded in preoperative assessment
Measured: On the day of C-section
Demographic data, previous obstetric history and their relation with ObsQoR-11 score on postpartum 1st day
Demographic data and previous obstetric history will be recorded in preoperative assessment
Measured: Postpartum 1st day
Demographic data, previous obstetric history and their relation with ObsQoR-11 score on postpartum 2nd day
Demographic data and previous obstetric history will be recorded in preoperative assessment
Measured: Postpartum 2nd day
Evaluation of the relationship between type of anaesthesia and ObsQoR-11 score on postpartum 1st day
Type of anaethesia will be recorded from the anaesthesia follow-up sheats. ObsQoR-11 will be evaluated on postpartum 1st day
Measured: each patient will be evaluated on postpartum 1st day
Evaluation of the relationship between type of anaesthesia and ObsQoR-11 score on postpartum 2nd day
Type of anaethesia will be recorded from the anaesthesia follow-up sheats. ObsQoR-11 will be evaluated on postpartum 2nd day
Measured: each patient will be evaluated on postpartum 2nd day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start20 Jan 2023
- Primary completion20 Mar 2023
- Study completion20 Mar 2023
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 Quality of LifeStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaye Sensoz Celik, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Investigators
- Gaye Şensöz Çelik, Principal investigator, Prof. Dr. Cemil Taşçıoğlu City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704179
- Sponsor's protocol ID
- 23052022162
- Status last verified
- Feb 2024
- First submitted
- 14 Nov 2022
- Last updated
- 14 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 30579408Bateman BT, Mhyre JM, Hernandez-Diaz S, Huybrechts KF, Fischer MA, Creanga AA, Callaghan WM, Gagne JJ. Development of a comorbidity index for use in obstetric patients. Obstet Gynecol. 2013 Nov;122(5):957-965. doi: 10.1097/AOG.0b013e3182a603bb.
PubMed 24104771Easter SR, Bateman BT, Sweeney VH, Manganaro K, Lassey SC, Gagne JJ, Robinson JN. A comorbidity-based screening tool to predict severe maternal morbidity at the time of delivery. Am J Obstet Gynecol. 2019 Sep;221(3):271.e1-271.e10. doi: 10.1016/j.ajog.2019.06.025. Epub 2019 Jun 20.
PubMed 31229427
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Obstetric Comorbidity Index and Obstetric Recovery Quality Score in Patients Who Undergo Operative Delivery
- ClinicalTrials.gov ID
- NCT05704179
- Acronym / sponsor ID
- 23052022162
- Conditions
- Quality of Life, Obstetric Complication, Cesarean Section Complications, Comorbidities and Coexisting Conditions, Obstetric Anesthesia Problems
- Keywords
- Obstetric comorbidity index, Obstetric Quality of Recovery, Cesarean section, Obstetric Anaesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 30 Jan 2023 (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.
The goal of this prospective observational study is to learn about the correlation between obstetric comorbidity index and obstetric quality of recovery score in pregnant patients who undergo cesarean section. The main question aims to answer are:
- Are there a correlation between the obstetric comorbidity index and the obstetric quality of recovery score? Can we predict the postoperative quality of recovery by calculating the obstetric comorbidity index before delivery?
- What is the relationship between these scores with the type of anaesthesia given? Participants will answer an 11-question assessment scale to evaluate their recovery of quality in the postpartum period.
Detailed description
After the approval of the ethics committee and the written informed consent of the patients, the patients who are meeting the criteria of inclusion will be included in the study. The demographic data, type of anaesthesia, intraoperative haemorrhage, length of hospital stay and intensive care unit stay(if applicable), the urgency category of the cesarean section, and complications will be recorded. patients will be evaluated with obstetric quality of recovery assessment score on postpartum 1st and 2nd days
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who undergo cesarean section | – | Other: Obstetric Quality of recovery scoreObstetric comorbidity index will be calculated for all patients, obstetric quality of recovery score will be evaluated in postpartum period( on the first and second day postpartum) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Turkish or English-speaking, >18 years old, pregnant patients who undergo cesarean section will be included in the study.
Key inclusion criteria (3 listed)
- Pregnant women who are admitted for Cesarean section > 18 years old
- Speaking Turkish or English
- Agreeing to participate in the study
Key exclusion criteria (3 listed)
- Pregnant women < 18 years old
- Can not speak Turkish or English
- Not agreeing to participate in the study
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 |
|---|---|---|
| Obstetric Quality of recovery scorePatients' quality of recovery will be evaluated with Obstetric Quality of recovery score (ObsQoR-11) on postpartum day 1 and day 2. | Other | Patients who undergo cesarean section |
Primary outcome
The correlation between Obstetric comorbidity index (OBCMI) and Obstetric Quality of Recovery score(ObsQoR-11) on postpartum 1st day
Time frame: each patient will be evaluated on postpartum 1st day
Obstetric comorbidity index will be calculated before c-section.ObsQoR-11 Questionnaire will be done postoperatively.
The correlation between Obstetric comorbidity index (OBCMI) and Obstetric Quality of Recovery score(ObsQoR-11) on postpartum 2nd day
Time frame: each patient will be evaluated on postpartum 2nd day
Obstetric comorbidity index will be calculated before c-section.ObsQoR-11 Questionnaire will be done postoperatively.
20 secondary outcomes
Evaluation of the relationship between type of anaesthesia and OBCMI
Time frame: each patient will be evaluated on the day of c-section
The relation between Lenght of hospital stay and ObsQoR-11 score on postpartum 1st day
Time frame: 2months
The relation between Lenght of hospital stay and ObsQoR-11 score on postpartum 2nd day
Time frame: 2months
The relation between complications and OBCMI
Time frame: 2months
The relation between complications and ObsQoR-11 on postpartum 1st day
Time frame: 2months
The relation between complications and ObsQoR-11 on postpartum 2nd day
Time frame: 2months
The relation between urgency of cesarean section and OBCMI
Time frame: each patient will be evaluated on the day of c-section
The relation between urgency of cesarean section and ObsQoR-11 score on postpartum 1st day
Time frame: each patient will be evaluated on the day of c-section
The relation between urgency of cesarean section and ObsQoR-11 score on postpartum 2nd day
Time frame: each patient will be evaluated on the day of c-section
The relation between intraoperative hemorrhage and OBCMI
Time frame: On the day of C-section
The relation between intraoperative hemorrhage and ObsQoR-11 score on postpartum 1st day
Time frame: On the day of C-section
The relation between intraoperative hemorrhage and ObsQoR-11 score on postpartum 2nd day
Time frame: The first 2 days postpartum
The relation between postoperative intensive care unit stay and OBCMI
Time frame: each patient will be evaluated on the day of c-section
The relation between postoperative intensive care unit stay and ObsQoR-11 score on 1st day
Time frame: each patient will be evaluated on postpartum 1st day
The relation between postoperative intensive care unit stay and ObsQoR-11 score on 2nd day
Time frame: each patient will be evaluated on postpartum 2nd day
Demographic data, previous obstetric history and their relation with OBCMI
Time frame: On the day of C-section
Demographic data, previous obstetric history and their relation with ObsQoR-11 score on postpartum 1st day
Time frame: Postpartum 1st day
Demographic data, previous obstetric history and their relation with ObsQoR-11 score on postpartum 2nd day
Time frame: Postpartum 2nd day
Evaluation of the relationship between type of anaesthesia and ObsQoR-11 score on postpartum 1st day
Time frame: each patient will be evaluated on postpartum 1st day
Evaluation of the relationship between type of anaesthesia and ObsQoR-11 score on postpartum 2nd day
Time frame: each patient will be evaluated on postpartum 2nd day
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 14 Feb 2024.
- Results publication: 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.
- Results publication: PubMed 24104771Bateman BT, Mhyre JM, Hernandez-Diaz S, Huybrechts KF, Fischer MA, Creanga AA, Callaghan WM, Gagne JJ. Development of a comorbidity index for use in obstetric patients. Obstet Gynecol. 2013 Nov;122(5):957-965. doi: 10.1097/AOG.0b013e3182a603bb.
- Results publication: PubMed 31229427Easter SR, Bateman BT, Sweeney VH, Manganaro K, Lassey SC, Gagne JJ, Robinson JN. A comorbidity-based screening tool to predict severe maternal morbidity at the time of delivery. Am J Obstet Gynecol. 2019 Sep;221(3):271.e1-271.e10. doi: 10.1016/j.ajog.2019.06.025. Epub 2019 Jun 20.
- Individual participant dataSharing planned: Undecided
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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.
Gaye Şensöz Çelik principal investigator
Prof. Dr. Cemil Taşçıoğlu City Hospital
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 Quality of Life and Obstetric Complication, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization 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 3 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 14 Feb 2024. 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?
The correlation between Obstetric comorbidity index (OBCMI) and Obstetric Quality of Recovery score(ObsQoR-11) on postpartum 1st day (time frame: each patient will be evaluated on postpartum 1st day). 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?
On the ClinicalTrials.gov record for NCT05704179, 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 14 Feb 2024.