Clinical trial NCT05704179: Evaluation of the Relationship Between Obstetric Comorbidity Index and Obstetric Quality of Recovery Score
Official title: Evaluation of the Relationship Between Obstetric Comorbidity Index and Obstetric Recovery Quality Score in Patients Who Undergo Operative Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Obstetric Complication
Cesarean Section Complications
Comorbidities and Coexisting Conditions
Obstetric Anesthesia Problems
Keywords: Obstetric comorbidity index
Obstetric Quality of Recovery
Cesarean section
Obstetric Anaesthesia
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 214
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Eligibility criteria: 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

Primary outcomes:
measure: The correlation between Obstetric comorbidity index (OBCMI) and Obstetric Quality of Recovery score(ObsQoR-11) on postpartum 1st day
timeFrame: each patient will be evaluated on postpartum 1st day
measure: The correlation between Obstetric comorbidity index (OBCMI) and Obstetric Quality of Recovery score(ObsQoR-11) on postpartum 2nd day
timeFrame: each patient will be evaluated on postpartum 2nd day
Secondary outcomes:
measure: Evaluation of the relationship between type of anaesthesia and OBCMI
timeFrame: each patient will be evaluated on the day of c-section
measure: The relation between Lenght of hospital stay and ObsQoR-11 score on postpartum 1st day
timeFrame: 2months
measure: The relation between Lenght of hospital stay and ObsQoR-11 score on postpartum 2nd day
timeFrame: 2months
measure: The relation between complications and OBCMI
timeFrame: 2months
measure: The relation between complications and ObsQoR-11 on postpartum 1st day
timeFrame: 2months
measure: The relation between complications and ObsQoR-11 on postpartum 2nd day
timeFrame: 2months
measure: The relation between urgency of cesarean section and OBCMI
timeFrame: each patient will be evaluated on the day of c-section
measure: The relation between urgency of cesarean section and ObsQoR-11 score on postpartum 1st day
timeFrame: each patient will be evaluated on the day of c-section
measure: The relation between urgency of cesarean section and ObsQoR-11 score on postpartum 2nd day
timeFrame: each patient will be evaluated on the day of c-section
measure: The relation between intraoperative hemorrhage and OBCMI
timeFrame: On the day of C-section
measure: The relation between intraoperative hemorrhage and ObsQoR-11 score on postpartum 1st day
timeFrame: On the day of C-section
measure: The relation between intraoperative hemorrhage and ObsQoR-11 score on postpartum 2nd day
timeFrame: The first 2 days postpartum
measure: The relation between postoperative intensive care unit stay and OBCMI
timeFrame: each patient will be evaluated on the day of c-section
measure: The relation between postoperative intensive care unit stay and ObsQoR-11 score on 1st day
timeFrame: each patient will be evaluated on postpartum 1st day
measure: The relation between postoperative intensive care unit stay and ObsQoR-11 score on 2nd day
timeFrame: each patient will be evaluated on postpartum 2nd day
measure: Demographic data, previous obstetric history and their relation with OBCMI
timeFrame: On the day of C-section
measure: Demographic data, previous obstetric history and their relation with ObsQoR-11 score on postpartum 1st day
timeFrame: Postpartum 1st day
measure: Demographic data, previous obstetric history and their relation with ObsQoR-11 score on postpartum 2nd day
timeFrame: Postpartum 2nd day
measure: Evaluation of the relationship between type of anaesthesia and ObsQoR-11 score on postpartum 1st day
timeFrame: each patient will be evaluated on postpartum 1st day
measure: Evaluation of the relationship between type of anaesthesia and ObsQoR-11 score on postpartum 2nd day
timeFrame: each patient will be evaluated on postpartum 2nd day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Prof. Dr. Cemil Taşçıoğlu Training and Research Hospital
Study officials:
affiliation: Prof. Dr. Cemil Taşçıoğlu City Hospital
name: Gaye Şensöz Çelik
role: PRINCIPAL_INVESTIGATOR
References:
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: 10.1016/j.bja.2018.06.011. Epub 2018 Jul 31.
citation: 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.
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.2019.06.025. Epub 2019 Jun 20.