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

NCT05704179 | Completed

• 1 other identifier: 23052022162
• Study Type: observational
• Target: 214
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (20)

• Evaluation of the relationship between type of anaesthesia and OBCMI

  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

  2months

• The relation between Lenght of hospital stay and ObsQoR-11 score on postpartum 2nd day

  2months

• The relation between complications and OBCMI

  2months

• The relation between complications and ObsQoR-11 on postpartum 1st day

  2months

Study Arms (1)

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

Interventions

Obstetric Quality of recovery score OTHER

Patients' quality of recovery will be evaluated with Obstetric Quality of recovery score (ObsQoR-11) on postpartum day 1 and day 2.

Patients who undergo cesarean section

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Pregnant women who are admitted for Cesarean section \> 18 years old
• Speaking Turkish or English
• Agreeing to participate in the study

You may not qualify if:

• Pregnant women \< 18 years old
• Can not speak Turkish or English
• Not agreeing to participate in the study

Sponsors & Collaborators

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

Study Sites (1)

Prof. Dr. Cemil Taşçıoğlu Training and Research Hospital

Istanbul, 0 (538) 314-55-, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 30579408 RESULT

• 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.

  PMID: 24104771 RESULT

• 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.

  PMID: 31229427 RESULT

Study Officials

• Gaye Şensöz Çelik

  Prof. Dr. Cemil Taşçıoğlu City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: January 30, 2023
• Study Start: January 20, 2023
• Primary Completion: March 20, 2023
• Study Completion: March 20, 2023
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

TU (1)