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

February 13, 2024 updated by: Gaye Sensoz Celik, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

214

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 0 (538) 314-55-
        • Prof. Dr. Cemil Taşcıoğlu Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Turkish or English-speaking, >18 years old, pregnant patients who undergo cesarean section will be included in the study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Other: Obstetric Quality of recovery score
Patients' quality of recovery will be evaluated with Obstetric Quality of recovery score (ObsQoR-11) on postpartum day 1 and day 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
each patient will be evaluated on postpartum 2nd day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Lenght of hospital stay will be recorded from hospital software.ObsQoR-11 will be evaluated on postpartum 1st day
2months
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
2months
The relation between complications and OBCMI
Time Frame: 2months
Complications will be recorded.
2months
The relation between complications and ObsQoR-11 on postpartum 1st day
Time Frame: 2months
Complications will be recorded
2months
The relation between complications and ObsQoR-11 on postpartum 2nd day
Time Frame: 2months
Complications will be recorded
2months
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
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
C-section category will be evaluated
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
C-section category will be evaluated
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
Instraoperative hemorrhage will be recorded from the anaesthesia follow-up sheats.
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
Instraoperative hemorrhage will be recorded from the anaesthesia follow-up sheats.
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
Instraoperative hemorrhage will be recorded from the anaesthesia follow-up sheats.
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
Postoperative intensive care unit need and lenght of stay will be recorded
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
Postoperative intensive care unit need and lenght of stay will be recorded.
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
Postoperative intensive care unit need and lenght of stay will be recorded.
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 and previous obstetric history will be recorded in preoperative assessment
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 and previous obstetric history will be recorded in preoperative assessment
Postpartum 1st day
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
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
Type of anaethesia will be recorded from the anaesthesia follow-up sheats. ObsQoR-11 will be evaluated on postpartum 1st day
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
Type of anaethesia will be recorded from the anaesthesia follow-up sheats. ObsQoR-11 will be evaluated on postpartum 2nd day
each patient will be evaluated on postpartum 2nd day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Investigators

  • Principal Investigator: Gaye Şensöz Çelik, Prof. Dr. Cemil Taşcıoğlu City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2023

Primary Completion (Actual)

March 20, 2023

Study Completion (Actual)

March 20, 2023

Study Registration Dates

First Submitted

November 14, 2022

First Submitted That Met QC Criteria

January 19, 2023

First Posted (Actual)

January 30, 2023

Study Record Updates

Last Update Posted (Estimated)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 23052022162

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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