Evaluation of the Relationship Between Obstetric Comorbidity Index and Obstetric Quality of Recovery Score

Completed

• Conditions: Quality of Life; Obstetric Anesthesia Problems; Comorbidities and Coexisting Conditions; Cesarean Section Complications; Obstetric Complication
• Interventions: Other: Obstetric Quality of recovery score

• Registration Number: NCT05704179
• Lead Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Brief 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. 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 Timeline

• Study First Submitted: 2022-11-14
• Study First Submitted QC: 2023-01-19
• Study Start: 2023-01-20
• Study First Posted: 2023-01-30
• Primary Completion: 2023-03-20
• Study Completion: 2023-03-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 214

Inclusion Criteria

• Pregnant women who are admitted for Cesarean section > 18 years old
• Speaking Turkish or English
• Agreeing to participate in the study

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Exclusion Criteria

• Pregnant women < 18 years old
• Can not speak Turkish or English
• Not agreeing to participate in the study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who undergo cesarean section	Obstetric Quality of recovery score	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)

Primary Outcome Measures

Name	Time	Method
The correlation between Obstetric comorbidity index (OBCMI) and Obstetric Quality of Recovery score(ObsQoR-11) on postpartum 2nd day	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.
The correlation between Obstetric comorbidity index (OBCMI) and Obstetric Quality of Recovery score(ObsQoR-11) on postpartum 1st day	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.

Secondary Outcome Measures

Name	Time	Method
The relation between Lenght of hospital stay and ObsQoR-11 score on postpartum 2nd day	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	2months	Complications will be recorded.
The relation between complications and ObsQoR-11 on postpartum 1st day	2months	Complications will be recorded
Demographic data, previous obstetric history and their relation with OBCMI	On the day of C-section	Demographic data and previous obstetric history will be recorded in preoperative assessment
The relation between postoperative intensive care unit stay and ObsQoR-11 score on 1st day	each patient will be evaluated on postpartum 1st day	Postoperative intensive care unit need and lenght of stay will be recorded.
The relation between Lenght of hospital stay and ObsQoR-11 score on postpartum 1st day	2months	Lenght of hospital stay will be recorded from hospital software.ObsQoR-11 will be evaluated on postpartum 1st day
The relation between urgency of cesarean section and ObsQoR-11 score on postpartum 1st day	each patient will be evaluated on the day of c-section	C-section category will be evaluated
The relation between intraoperative hemorrhage and OBCMI	On the day of C-section	Instraoperative hemorrhage will be recorded from the anaesthesia follow-up sheats.
The relation between postoperative intensive care unit stay and OBCMI	each patient will be evaluated on the day of c-section	Postoperative intensive care unit need and lenght of stay will be recorded
Evaluation of the relationship between type of anaesthesia and OBCMI	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 complications and ObsQoR-11 on postpartum 2nd day	2months	Complications will be recorded
The relation between urgency of cesarean section and OBCMI	each patient will be evaluated on the day of c-section	C-section category will be evaluated
The relation between intraoperative hemorrhage and ObsQoR-11 score on postpartum 2nd day	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 ObsQoR-11 score on 2nd day	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 ObsQoR-11 score on postpartum 2nd day	Postpartum 2nd day	Demographic data and previous obstetric history will be recorded in preoperative assessment
The relation between urgency of cesarean section and ObsQoR-11 score on postpartum 2nd day	each patient will be evaluated on the day of c-section	C-section category will be evaluated
Evaluation of the relationship between type of anaesthesia and ObsQoR-11 score on postpartum 2nd day	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
The relation between intraoperative hemorrhage and ObsQoR-11 score on postpartum 1st day	On the day of C-section	Instraoperative hemorrhage will be recorded from the anaesthesia follow-up sheats.
Demographic data, previous obstetric history and their relation with ObsQoR-11 score on postpartum 1st day	Postpartum 1st 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	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

Trial Locations

Locations (1)

Prof. Dr. Cemil Taşçıoğlu Training and Research Hospital; 🇹🇷 Istanbul, Turkey