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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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