Breastfeeding, Postoperative Nausea, Postoperative Pain, Quality of Life
Conditions
Keywords
Cesarean Delivery, Quality of Recovery, Preoperative Carbonhyrate Fluid
Brief summary
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.
Detailed description
The 10-item Obstetric Quality-of-Recovery scale is a validated patient-reported outcome questionnaire that evaluates recovery quality after delivery. Carbohydrate loading before the surgery in obstetric patients reduce the incidence of nausea and vomiting and reduce insulin resistance. The shortened pre-operative fasting period, in addition to the positive metabolic effects, enhance the post-operative recovery and shorten the hospital stay. Postoperatively, it is also crucial for the mother to heal rapidly and be able to care for her child on her own. Although a lot of effects of the preoperative carbohydrate loading has been studied yet, the OQR-10 scale and after carbohydrate loading has not been investigated yet. All mothers undergoing a planned CD in the Karaman Training and Research Hospital will be invited to participate. Mothers will be divided into two groups. One group will receive carbohydrate solution ( Carb Group) and the other will consume same amount of placebo fluid (Noncarb Group). The aim of this study is to determine the effect of carbonhydrate rich solutions on quality of recovery of parturients undergoing elective CD with Obstetric Quality of Recovery-10 (ObsQoR-10) Scoring Tool.
Interventions
DRUGCarbohydrate
The experimental group of patients will consume the carbohydrate rich fluid 2 hours before the elective CD.
DRUGPlacebo
The control group will be offered same amount of placebo fluid.
Sponsors
Karamanoğlu Mehmetbey University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The patients in CHO group will be offered carbohyrate rich preoperative fluid on the other hand the patients in Control Group will be offered placebo fluids resemble to carbohydrate rich preoperative drink. The investigators, care provider and outcome accessors also will be blinded to the group assignment of the patients.
Intervention model description
Randomized, double blinded
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Obstetric Quality of Recovery-10 (ObsQoR-10) score 24 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Obstetric Quality of Recovery-10 (ObsQoR-10) score 72 hours | 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. |
| Obstetric Quality of Recovery-10 (ObsQoR-10) score 7 days | 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. |
| Hospital discharge | 7 days | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed