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QoR-10: Quality of Recovery in Parturients Consumed Preoperative Carbohydrate Fluid for Elective Cesarean Delivery

Sponsor
Karamanoğlu Mehmetbey University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05841693
Collaborator
(none)
100
Enrollment
2
Arms
3.4
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, double blindedRandomized, double blinded
Masking:
Quadruple (Participant, Care Provider, 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.
Primary Purpose:
Treatment
Official Title:
Quality of Recovery in Parturients Consumed Preoperative Carbohydrate Fluid for Elective Cesarean Delivery- An Obsevational Study
Anticipated Study Start Date :
Apr 30, 2023
Anticipated Primary Completion Date :
Jul 30, 2023
Anticipated Study Completion Date :
Aug 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Drug: Carbohydrate
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 Comparator: 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

    Drug: Placebo
    The control group will be offered same amount of placebo fluid.
    Other Names:
  • Preoperative placebo fluid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Karamanoğlu Mehmetbey University

    Investigators

    • Principal Investigator: Ozlem Dulger, Assist Prof, Karaman Training and Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ozlem Dulger, Assist Prof, Karamanoğlu Mehmetbey University
    ClinicalTrials.gov Identifier:
    NCT05841693
    Other Study ID Numbers:
    • 1111
    First Posted:
    May 3, 2023
    Last Update Posted:
    May 3, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Ozlem Dulger, Assist Prof, Karamanoğlu Mehmetbey University
    Cesarean Delivery
    Quality of Recovery
    Preoperative Carbonhyrate Fluid
    Additional relevant MeSH terms:
    Postoperative Nausea and Vomiting

    Study Results

    No Results Posted as of May 3, 2023