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

Quality of Life Clinical Trial

Official title:

Evaluation of the Relationship Between Obstetric Comorbidity Index and Obstetric Recovery Quality Score in Patients Who Undergo Operative Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05704179
• Other study ID #: 23052022162
• Status: Completed
• Start date: January 20, 2023
• Est. completion date: March 20, 2023

Study information

• Verified date: February 2024
• Source: Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: March 20, 2023
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications
• Comorbidities and Coexisting Conditions
• Obstetric Anesthesia Problems
• Obstetric Complication
• Quality of Life

Intervention

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.

Locations

Country	Name	City	State
Turkey	Prof. Dr. Cemil Tasçioglu Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Bateman BT, Mhyre JM, Hernandez-Diaz S, Huybrechts KF, Fischer MA, Creanga AA, Callaghan WM, Gagne JJ. Development of a comorbidity index for use in obstetric patients. Obstet Gynecol. 2013 Nov;122(5):957-965. doi: 10.1097/AOG.0b013e3182a603bb. — View Citation

Ciechanowicz S, Setty T, Robson E, Sathasivam C, Chazapis M, Dick J, Carvalho B, Sultan P. Development and evaluation of an obstetric quality-of-recovery score (ObsQoR-11) after elective Caesarean delivery. Br J Anaesth. 2019 Jan;122(1):69-78. doi: 10.101 — View Citation

Easter SR, Bateman BT, Sweeney VH, Manganaro K, Lassey SC, Gagne JJ, Robinson JN. A comorbidity-based screening tool to predict severe maternal morbidity at the time of delivery. Am J Obstet Gynecol. 2019 Sep;221(3):271.e1-271.e10. doi: 10.1016/j.ajog.201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The correlation between Obstetric comorbidity index (OBCMI) and Obstetric Quality of Recovery score(ObsQoR-11) 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
Primary	The correlation between Obstetric comorbidity index (OBCMI) and Obstetric Quality of Recovery score(ObsQoR-11) 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	Evaluation of the relationship between type of anaesthesia and OBCMI	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
Secondary	The relation between Lenght of hospital stay and ObsQoR-11 score on postpartum 1st day	Lenght of hospital stay will be recorded from hospital software.ObsQoR-11 will be evaluated on postpartum 1st day	2months
Secondary	The relation between Lenght of hospital stay and ObsQoR-11 score on postpartum 2nd day	Lenght of hospital stay will be recorded from hospital software. ObsQoR-11 will be evaluated on postpartum 2nd day	2months
Secondary	The relation between complications and OBCMI	Complications will be recorded.	2months
Secondary	The relation between complications and ObsQoR-11 on postpartum 1st day	Complications will be recorded	2months
Secondary	The relation between complications and ObsQoR-11 on postpartum 2nd day	Complications will be recorded	2months
Secondary	The relation between urgency of cesarean section and OBCMI	C-section category will be evaluated	each patient will be evaluated on the day of c-section
Secondary	The relation between urgency of cesarean section and ObsQoR-11 score on postpartum 1st day	C-section category will be evaluated	each patient will be evaluated on the day of c-section
Secondary	The relation between urgency of cesarean section and ObsQoR-11 score on postpartum 2nd day	C-section category will be evaluated	each patient will be evaluated on the day of c-section
Secondary	The relation between intraoperative hemorrhage and OBCMI	Instraoperative hemorrhage will be recorded from the anaesthesia follow-up sheats.	On the day of C-section
Secondary	The relation between intraoperative hemorrhage and ObsQoR-11 score on postpartum 1st day	Instraoperative hemorrhage will be recorded from the anaesthesia follow-up sheats.	On the day of C-section
Secondary	The relation between intraoperative hemorrhage and ObsQoR-11 score on postpartum 2nd day	Instraoperative hemorrhage will be recorded from the anaesthesia follow-up sheats.	The first 2 days postpartum
Secondary	The relation between postoperative intensive care unit stay and OBCMI	Postoperative intensive care unit need and lenght of stay will be recorded	each patient will be evaluated on the day of c-section
Secondary	The relation between postoperative intensive care unit stay and ObsQoR-11 score on 1st day	Postoperative intensive care unit need and lenght of stay will be recorded.	each patient will be evaluated on postpartum 1st day
Secondary	The relation between postoperative intensive care unit stay and ObsQoR-11 score on 2nd day	Postoperative intensive care unit need and lenght of stay will be recorded.	each patient will be evaluated on postpartum 2nd day
Secondary	Demographic data, previous obstetric history and their relation with OBCMI	Demographic data and previous obstetric history will be recorded in preoperative assessment	On the day of C-section
Secondary	Demographic data, previous obstetric history and their relation with ObsQoR-11 score on postpartum 1st day	Demographic data and previous obstetric history will be recorded in preoperative assessment	Postpartum 1st day
Secondary	Demographic data, previous obstetric history and their relation with ObsQoR-11 score on postpartum 2nd day	Demographic data and previous obstetric history will be recorded in preoperative assessment	Postpartum 2nd day
Secondary	Evaluation of the relationship between type of anaesthesia and ObsQoR-11 score 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
Secondary	Evaluation of the relationship between type of anaesthesia and ObsQoR-11 score 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