Prof. Dr. Cemil Taşçıoğlu Training and Research Hospital
Istanbul, 0 (538) 314-55-, Turkey (Türkiye)
Completed
NCT Number: NCT05704179
Evaluation of the Relationship Between Obstetric Comorbidity Index and Obstetric Quality of Recovery Score
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Observational
Primary location
About this study
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
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Pregnant women who are admitted for Cesarean section > 18 years old
- Speaking Turkish or English
- Agreeing to participate in the study
Exclusion criteria
- Pregnant women < 18 years old
- Can not speak Turkish or English
- Not agreeing to participate in the study
Treatment and study plan
Obstetric Quality of recovery score
OtherPatients' quality of recovery will be evaluated with Obstetric Quality of recovery score (ObsQoR-11) on postpartum day 1 and day 2.
Primary outcomes
-
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.
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
Type of anaethesia will be recorded from the anaesthesia follow-up sheats. Obstetric comorbidity index will be calculated before c-section.
-
The relation between Lenght of hospital stay and ObsQoR-11 score on postpartum 1st day
Time frame: 2months
Lenght of hospital stay will be recorded from hospital software.ObsQoR-11 will be evaluated on postpartum 1st day
-
The relation between Lenght of hospital stay and ObsQoR-11 score on postpartum 2nd day
Time frame: 2months
Lenght of hospital stay will be recorded from hospital software. ObsQoR-11 will be evaluated on postpartum 2nd day
-
The relation between complications and OBCMI
Time frame: 2months
Complications will be recorded.
-
The relation between complications and ObsQoR-11 on postpartum 1st day
Time frame: 2months
Complications will be recorded
-
The relation between complications and ObsQoR-11 on postpartum 2nd day
Time frame: 2months
Complications will be recorded
-
The relation between urgency of cesarean section and OBCMI
Time frame: each patient will be evaluated on the day of c-section
C-section category will be evaluated
-
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
C-section category will be evaluated
-
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
C-section category will be evaluated
-
The relation between intraoperative hemorrhage and OBCMI
Time frame: On the day of C-section
Instraoperative hemorrhage will be recorded from the anaesthesia follow-up sheats.
-
The relation between intraoperative hemorrhage and ObsQoR-11 score on postpartum 1st day
Time frame: On the day of C-section
Instraoperative hemorrhage will be recorded from the anaesthesia follow-up sheats.
-
The relation between intraoperative hemorrhage and ObsQoR-11 score on postpartum 2nd day
Time frame: The first 2 days postpartum
Instraoperative hemorrhage will be recorded from the anaesthesia follow-up sheats.
-
The relation between postoperative intensive care unit stay and OBCMI
Time frame: each patient will be evaluated on the day of c-section
Postoperative intensive care unit need and lenght of stay will be recorded
-
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
Postoperative intensive care unit need and lenght of stay will be recorded.
-
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
Postoperative intensive care unit need and lenght of stay will be recorded.
-
Demographic data, previous obstetric history and their relation with OBCMI
Time frame: On the day of C-section
Demographic data and previous obstetric history will be recorded in preoperative assessment
-
Demographic data, previous obstetric history and their relation with ObsQoR-11 score on postpartum 1st day
Time frame: Postpartum 1st day
Demographic data and previous obstetric history will be recorded in preoperative assessment
-
Demographic data, previous obstetric history and their relation with ObsQoR-11 score on postpartum 2nd day
Time frame: Postpartum 2nd day
Demographic data and previous obstetric history will be recorded in preoperative assessment
-
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
Type of anaethesia will be recorded from the anaesthesia follow-up sheats. ObsQoR-11 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
Type of anaethesia will be recorded from the anaesthesia follow-up sheats. ObsQoR-11 will be evaluated on postpartum 2nd day
Sponsors and collaborators
Lead sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Other
Registry information
Official study title
Evaluation of the Relationship Between Obstetric Comorbidity Index and Obstetric Recovery Quality Score in Patients Who Undergo Operative Delivery
Important dates
- Study start
- 2023
- Primary completion
- 2023
- Study completion
- 2023
- First posted
- Jan 30, 2023
- Registry last updated
- Feb 14, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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