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

Primary Purpose

Quality of Life, Breastfeeding, Postoperative Pain

Status
Recruiting
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Carbohydrate
Placebo
Sponsored by
Karamanoğlu Mehmetbey University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Quality of Life focused on measuring Cesarean Delivery, Quality of Recovery, Preoperative Carbonhyrate Fluid

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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who have given informed written consent Exclusion Criteria: Patients who have refused, are unable to give or have withdrawn consent Patients with American Society of Anesthesiologists (ASA) classification of 4 or greater Patients with history of chronic pain, chronic use of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

Sites / Locations

  • Karaman Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Experimental ( Carb Group)

Standard Care (Non-carb Group)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 11, 2023
Last Updated
May 12, 2023
Sponsor
Karamanoğlu Mehmetbey University
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1. Study Identification

Unique Protocol Identification Number
NCT05841693
Brief Title
Quality of Recovery in Parturients Consumed Preoperative Carbohydrate Fluid for Elective Cesarean Delivery
Acronym
QoR-10
Official Title
Quality of Recovery in Parturients Consumed Preoperative Carbohydrate Fluid for Elective Cesarean Delivery- An Obsevational Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2023 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
August 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karamanoğlu Mehmetbey University

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Breastfeeding, Postoperative Pain, Postoperative Nausea
Keywords
Cesarean Delivery, Quality of Recovery, Preoperative Carbonhyrate Fluid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double blinded
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental ( Carb Group)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard Care (Non-carb Group)
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Carbohydrate
Other Intervention Name(s)
Preoperative carbohydrate rich feeding solution
Intervention Description
The experimental group of patients will consume the carbohydrate rich fluid 2 hours before the elective CD.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Preoperative placebo fluid
Intervention Description
The control group will be offered same amount of placebo fluid.
Primary Outcome Measure Information:
Title
Obstetric Quality of Recovery-10 (ObsQoR-10) score 24 hours
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Obstetric Quality of Recovery-10 (ObsQoR-10) score 72 hours
Description
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.
Time Frame
72 hours
Title
Obstetric Quality of Recovery-10 (ObsQoR-10) score 7 days
Description
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.
Time Frame
7 days
Title
Hospital discharge
Description
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.
Time Frame
7 days

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female patients undergoing electve cesarean delivery
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ozlem Dulger, Assist prof
Phone
+ 90 338 226 20 00
Email
ozlem_dulger@yahoo.com.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Betul Basaran, MD, DESA,
Phone
+90 338 226 20 00
Email
betulbasaran1@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozlem Dulger, Assist Prof
Organizational Affiliation
Karaman Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karaman Training and Research Hospital
City
Karaman
ZIP/Postal Code
70200
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ozlem Dulger
Phone
+903382262000
Email
ozlem_dulger@yahoo.com.tr
First Name & Middle Initial & Last Name & Degree
Betul Basaran, MD
Phone
+903382262000
Email
betulbasaran1@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data of the study will be shared on demand.

Learn more about this trial

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

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