Quality of Life Clinical Trial
— QoR-10Official title:
Quality of Recovery in Parturients Consumed Preoperative Carbohydrate Fluid for Elective Cesarean Delivery- An Obsevational Study
NCT number | NCT05841693 |
Other study ID # | 1111 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | May 12, 2023 |
Est. completion date | March 10, 2024 |
Verified date | March 2024 |
Source | Karamanoglu Mehmetbey University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The establishment of the Enhanced Recovery After Cesarean protocols resulted in to the production of specific care pathways with the aim of optimizing recovery after cesarean delivery (CD) and to reduce the costs to the health care system. Carbohydrate rich fluids are offered in this aspect to enhance postoperative quality of recovery. The primary aim of this randomised control trial is to assess the impact of pre-operative carbohydrate loading on obstetric quality of recovery after elective cesarean section.
Status | Completed |
Enrollment | 100 |
Est. completion date | March 10, 2024 |
Est. primary completion date | February 28, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Women aged 18 years old and over - Term singleton pregnancy - Undergoing planned caesarean delivery at Karaman Training and Research Hospital - Patients who have given informed written consent Exclusion Criteria: - Patients who have refused, are unable to give or have withdrawn consent - Patients with American Society of Anesthesiologists (ASA) classification of 4 or greater - Patients with history of chronic pain, chronic use of analgesic drugs, or history of opioid or intravenous drug abuse - Patients who have refused spinal anesthesia, or those in whom it is contraindicated. - Pregnancy with preeclampsia or eclampsia - Pregnancy with gestational diabetes mellitus or diabetes mellitus |
Country | Name | City | State |
---|---|---|---|
Turkey | Karaman Training and Research Hospital | Karaman |
Lead Sponsor | Collaborator |
---|---|
Karamanoglu Mehmetbey University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Obstetric Quality of Recovery-10 (ObsQoR-10) score 24 hours | ObsQoR-10 score at 24 hours after surgery for both parturients consumed carbohydrate rich solution or placebo fluid. There are 10 questions, and the results are tabulated out of 100. The higher the overall score out of 100, the better quality of recovery a patient is experiencing. | 24 hours | |
Secondary | Obstetric Quality of Recovery-10 (ObsQoR-10) score 72 hours | ObsQoR-10 score at 72 hours after surgery for both parturients consumed carbohydrate rich solution or placebo fluid. There are 10 questions, and the results are tabulated out of 100. The higher the overall score out of 100, the better quality of recovery a patient is experiencing. | 72 hours | |
Secondary | Obstetric Quality of Recovery-10 (ObsQoR-10) score 7 days | ObsQoR-10 score at 7 days after surgery for both parturients consumed carbohydrate rich solution or placebo fluid. There are 10 questions, and the results are tabulated out of 100. The higher the overall score out of 100, the better quality of recovery a patient is experiencing. | 7 days | |
Secondary | Hospital discharge | The parturients will be discharged from the hospital after they met the discharge criteria. This parameter reported as number of days after the operation to the day in which the patient met discharge criteria. | 7 days |
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