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

• Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05704179
• Collaborator: (none)
• Enrollment: 160
• Location: 1
• Anticipated Duration (Months): 1.9
• Patients Per Site Per Month: 82.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Quality of Life; Obstetric Complication; Cesarean Section Complications; Comorbidities and Coexisting Conditions; Obstetric Anesthesia Problems	Other: Obstetric Quality of recovery score

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

• Study Type: Observational
• Anticipated Enrollment: 160 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of the Relationship Between Obstetric Comorbidity Index and Obstetric Recovery Quality Score in Patients Who Undergo Operative Delivery
• Anticipated Study Start Date: Jan 20, 2023
• Anticipated Primary Completion Date: Mar 20, 2023
• Anticipated Study Completion Date: Mar 20, 2023

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Secondary Outcome Measures

1. 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.

2. 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

3. 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

4. The relation between complications and OBCMI [2months]

   Complications will be recorded.

5. The relation between complications and ObsQoR-11 on postpartum 1st day [2months]

   Complications will be recorded

6. The relation between complications and ObsQoR-11 on postpartum 2nd day [2months]

   Complications will be recorded

7. 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

8. 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

9. 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

10. The relation between intraoperative hemorrhage and OBCMI [On the day of C-section]

    Instraoperative hemorrhage will be recorded from the anaesthesia follow-up sheats.

11. 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.

12. 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.

13. 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

14. 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.

15. 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.

16. 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

17. 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

18. 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

19. 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

20. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prof. Dr. Cemil Taşçıoğlu Training and Research Hospital	Istanbul		Turkey	0 (538) 314-55-

Sponsors and Collaborators

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gaye Sensoz Celik, Principal investigator, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
• ClinicalTrials.gov Identifier: NCT05704179
• Other Study ID Numbers: 23052022162
• First Posted: Jan 30, 2023
• Last Update Posted: Jan 30, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Gaye Sensoz Celik, Principal investigator, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: Obstetric comorbidity index; Obstetric Quality of Recovery; Cesarean section; Obstetric Anaesthesia

Study Results

No Results Posted as of Jan 30, 2023