NCT07204795

Brief Summary

The goal of this clinical trial is to determine whether a preoperative oral carbohydrate-rich clear drink can improve recovery in women undergoing elective cesarean section under neuraxial anesthesia. The main outcomes it aims to answer are: Primary Outcome: Does the carbohydrate drink improve ObsQoR-10 scores at 24 and 48 hours postoperatively? Secondary Outcomes: Does it reduce patients' hunger, thirst, and anxiety levels? Researchers will compare patients receiving a 400 ml oral carbohydrate-rich clear drink 2 hours before surgery (Group A) to those receiving 400 ml distilled water (Group B), to assess differences in recovery and comfort. Participants will: Be randomized into two equal groups (n=50 each) using a computer-generated randomization table Receive standardized anesthesia and postoperative analgesia

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

May 20, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 2, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

11 months

First QC Date

May 17, 2025

Last Update Submit

September 30, 2025

Conditions

ObsQor-10Cesarean SectionPreoperative Fasting

Keywords

ObsQor-10Cesarean SectionNeuraxial AnesthesiaPreoperative FastingOral Clear Carbohydrate Drink

Outcome Measures

Primary Outcomes (1)

  • ObsQor-10 Scores

    Primary outcome assessment will be based on the ObsQoR-10 (Obstetric Quality of Recovery-10) scores at 24 and 48 hours postoperatively.

    From enrollment to 48th hour postoperatively

Study Arms (2)

Control Group

SHAM COMPARATOR

Control Group will receive distilled water.

Other: Distilled water group

Intervention Group

EXPERIMENTAL

This arm of patients will receive clear carbohydrate drink.

Other: Carbohydrate Drink

Interventions

Distilled water groupOTHER

Group A participants will receive 400 mL of distilled water orally, two hours before surgery.

Control Group
Carbohydrate DrinkOTHER

Group A participants will receive 400 mL of a commercially available clear carbohydrate-rich drink orally, two hours before surgery.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Scheduled for elective cesarean section under neuraxial anesthesia
  • Gestational age ≥37 weeks

You may not qualify if:

  • Contraindication to neuraxial anesthesia
  • Age \<18 years
  • Refusal to participate in the study
  • Obesity
  • Hiatal hernia
  • Intestinal obstruction
  • Gastroesophageal reflux disease (GERD)
  • Diabetes mellitus
  • Fetal anomalies
  • Eclampsia or preeclampsia
  • Substance abuse
  • Chronic pain conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University Research Hospital

Erzurum, 25700, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Kozanhan B, Yildiz M, Polat A, Gunenc O, Tutar SM, Iyisoy MS, Kulhan NG, Sultan P. Development and Validation of a Turkish Version of Obstetric Quality of Recovery-10. Turk J Anaesthesiol Reanim. 2022 Oct;50(5):366-372. doi: 10.5152/TJAR.2022.21441.

    PMID: 36301286BACKGROUND

  • Cho EA, Huh J, Lee SH, Ryu KH, Shim JG, Cha YB, Kim MS, Song T. Gastric Ultrasound Assessing Gastric Emptying of Preoperative Carbohydrate Drinks: A Randomized Controlled Noninferiority Study. Anesth Analg. 2021 Sep 1;133(3):690-697. doi: 10.1213/ANE.0000000000005411.

    PMID: 33591115BACKGROUND

  • Ciechanowicz S, Setty T, Robson E, Sathasivam C, Chazapis M, Dick J, Carvalho B, Sultan P. Development and evaluation of an obstetric quality-of-recovery score (ObsQoR-11) after elective Caesarean delivery. Br J Anaesth. 2019 Jan;122(1):69-78. doi: 10.1016/j.bja.2018.06.011. Epub 2018 Jul 31.

    PMID: 30579408BACKGROUND

Central Study Contacts

Ayşenur Dostbil, Proffessor

CONTACT

+905333676696adostbil@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr.

Study Record Dates

First Submitted

May 17, 2025

First Posted

October 2, 2025

Study Start

May 20, 2025

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Locations

TU(1)