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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental ( Carb Group) | Active Comparator | Preoperative education will be provided by researchers to the patients on the ward before fluid intake.Solid food and drinking will be forbidden after 24:00 p.m the day before surgery. The Carb group will consume carbonhydrate fluid two hours before the surgery. |
|
| Standard Care (Non-carb Group) | Placebo Comparator | Preoperative education will be provided by researchers to the patients on the ward before fluid intake. Solid food and drinking will be forbidden after 24:00 p.m the day before surgery.The Non-carb Group will consume same amount of placebo fluid as Carb Group two hours before the surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbohydrate | Drug | The experimental group of patients will consume the carbohydrate rich fluid 2 hours before the elective CD. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Female patients undergoing electve cesarean delivery
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| Name | Affiliation | Role |
|---|---|---|
| Ozlem Dulger, Assist Prof | Karaman Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karaman Training and Research Hospital | Karaman | 70200 | Turkey (Türkiye) |
The data of the study will be shared on demand.
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D010149 | Pain, Postoperative |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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Randomized, double blinded
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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.
| Placebo | Drug | The control group will be offered same amount of placebo fluid. |
|
|
| 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 |
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |