Clinical trial NCT05841693: Quality of Recovery in Parturients Consumed Preoperative Carbohydrate Fluid for Elective Cesarean Delivery
Official title: Quality of Recovery in Parturients Consumed Preoperative Carbohydrate Fluid for Elective Cesarean Delivery- An Obsevational Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Quality of Life
Breastfeeding
Postoperative Pain
Postoperative Nausea
Keywords: Cesarean Delivery
Quality of Recovery
Preoperative Carbonhyrate Fluid
Lead sponsor: Karamanoğlu Mehmetbey University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double blinded
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Obstetric Quality of Recovery-10 (ObsQoR-10) score 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: Obstetric Quality of Recovery-10 (ObsQoR-10) score 72 hours
timeFrame: 72 hours
measure: Obstetric Quality of Recovery-10 (ObsQoR-10) score 7 days
timeFrame: 7 days
measure: Hospital discharge
timeFrame: 7 days
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Training and Research Hospital
Study officials:
affiliation: Karaman Training and Research Hospital
name: Ozlem Dulger, Assist Prof
role: PRINCIPAL_INVESTIGATOR
References: