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Completed

NCT Number: NCT05841693

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

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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Key information

Conditions

Quality of Life Behavior Breast Feeding Breastfeeding Feeding Behavior Nausea Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea Postoperative Nausea and Vomiting Postoperative Pain Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Karaman Training and Research Hospital

Karaman, 70200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carbohydrate

Drug

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

Other names: Preoperative carbohydrate rich feeding solution

Placebo

Drug

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

Other names: Preoperative placebo fluid

Primary outcomes

  1. Obstetric Quality of Recovery-10 (ObsQoR-10) score 24 hours

    Time frame: 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 outcomes

  1. Obstetric Quality of Recovery-10 (ObsQoR-10) score 72 hours

    Time frame: 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.

  2. Obstetric Quality of Recovery-10 (ObsQoR-10) score 7 days

    Time frame: 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.

  3. Hospital discharge

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Karamanoğlu Mehmetbey University

Other

Registry information

Official study title

Quality of Recovery in Parturients Consumed Preoperative Carbohydrate Fluid for Elective Cesarean Delivery- An Obsevational Study

Acronym: QoR-10

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 3, 2023
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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