Quality of Recovery in Parturients Consumed Preoperative Carbohydrate Fluid for Elective Cesarean Delivery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-12

Study Completion Date

2024-03-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Quality of Life Breastfeeding Postoperative Pain Postoperative Nausea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double blinded

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Experimental ( Carb Group)

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.

Group Type ACTIVE_COMPARATOR

Carbohydrate

Intervention Type DRUG

The experimental group of patients will consume the carbohydrate rich fluid 2 hours before the elective CD.

Standard Care (Non-carb Group)

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The control group will be offered same amount of placebo fluid.

Interventions

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Carbohydrate

The experimental group of patients will consume the carbohydrate rich fluid 2 hours before the elective CD.

Intervention Type DRUG

Placebo

The control group will be offered same amount of placebo fluid.

Intervention Type DRUG

Other Intervention Names

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Preoperative carbohydrate rich feeding solution Preoperative placebo fluid

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes