Preoperative Oral Carbohydrate for Nausea and Vomiting Prevention During Cesarian Section

NCT04069806 | Unknown DMC

• 1 other identifier: PUM_08.08.2019
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Post-operative nausea and vomiting (PONV) in women undergoing subarachnoid anesthesia for Caesarean section is an important clinical problem. The aim of this study is to compare the effectiveness of oral carbohydrate loading to standard pre-operative fasting in patients undergoing elective cesarean section on the incidence and severity of PONV and biochemical parameters indicating ketosis.

Conditions

Postoperative Nausea and Vomiting

Keywords

Nausea; Vomiting; Oral carbohydrate; Fasting

Outcome Measures

Primary Outcomes (2)

• Postoperative nausea and vomiting 6 hours after caesarian section.

  The Postoperative Nausea and Vomiting (PONV) Intensity Scale 6 hours after caesarian section. Scale range: 0-50. The scale measures PONV intensity, where a score ≥50 defined clinically important PONV: PONV Intensity Scale=severity of nausea (1=mild, 2=moderate, 3=severe)×pattern of nausea (1=varying, 2=constant)×duration of nausea (in hours).

  6 hours

• Postoperative nausea and vomiting 24 hours after caesarian section.

  The Postoperative Nausea and Vomiting (PONV) Intensity Scale 24 hours after caesarian section. Scale range: 0-50. The scale measures PONV intensity, where a score ≥50 defined clinically important PONV: PONV Intensity Scale=severity of nausea (1=mild, 2=moderate, 3=severe)×pattern of nausea (1=varying, 2=constant)×duration of nausea (in hours).

  24 hours

Secondary Outcomes (6)

• Time to first peristalsis.

  24 hours

• Time to first bowel movement.

  24 hours

• Concentration of serum lactate in serum.

  0 hours

• Concentration of beta-hydroxy-butiric acid in serum.

  0 hours

• Insulin resistance factor (HOMA-IR).

  0 hours

Study Arms (2)

Preoperative oral carbohydrate load

EXPERIMENTAL

6 hours for solid food and 2 hours for liquids + oral carbohydrate preparation 2 hours prior to surgery.

Dietary Supplement: preoperative oral carbohydrate, preOp

Standard preoperative fasting

NO INTERVENTION

6 hours for solid food and 2 hours for liquids.

Interventions

preoperative oral carbohydrate, preOp DIETARY_SUPPLEMENT

Patients in the experimental arm will receive oral carbohydrate preparation at 2 hours prior to planned caesarian section.

Preoperative oral carbohydrate load

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant patients scheduled for planned cesarian section.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>=18 years.
• Scheduled for an elective cesarean section.
• Uncomplicated pregnancy.
• Planned for spinal anesthesia.
• ASA I or ASA II.

You may not qualify if:

• History of diabetes.
• History of gastro-intestinal reflux (GERD).
• Unable or unwilling to sign an informed consent.
• Contraindications to spinal anesthesia.
• Contraindication to Oral carbohydrate formula.

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead

Study Sites (1)

Pomeranian Medical University

Szczecin, 70-111, Poland

RECRUITING

Related Publications (2)

• Kotfis K, Jamiol-Milc D, Wojciechowska A, Szylinska A, Drozd A, Zimny M, Dolegowska B, Kwiatkowski S, Dziedziejko V, Safranow K. Maternal and umbilical cord plasma purine concentrations after oral carbohydrate loading prior to elective Cesarean delivery under spinal anesthesia: a randomized controlled trial. BMC Pregnancy Childbirth. 2025 May 10;25(1):556. doi: 10.1186/s12884-025-07637-6.

  PMID: 40348958 DERIVED

• Kotfis K, Wojciechowska A, Zimny M, Jamiol-Milc D, Szylinska A, Kwiatkowski S, Kaim K, Dolegowska B, Stachowska E, Zukowski M, Pankowiak M, Torbe A, Wischmeyer P. Preoperative Oral Carbohydrate (CHO) Supplementation Is Beneficial for Clinical and Biochemical Outcomes in Patients Undergoing Elective Cesarean Delivery under Spinal Anaesthesia-A Randomized Controlled Trial. J Clin Med. 2023 Jul 28;12(15):4978. doi: 10.3390/jcm12154978.

  PMID: 37568381 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Nausea; Vomiting; Fasting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms; Feeding Behavior; Behavior

Study Officials

• Katarzyna L Kotfis, MD, PhD

  Pomeranian Medical University

  PRINCIPAL INVESTIGATOR

• Sebastian Kwiatkowski, MD, PhD

  Pomeranian Medical University

  STUDY CHAIR

Central Study Contacts

Katarzyna L Kotfis, MD, PhD

CONTACT

0048914661144; katarzyna.kotfis@pum.edu.pl

Arleta Wojciechowska, RN

CONTACT

arletawoj@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 28, 2019
• Study Start: September 3, 2019
• Primary Completion: March 31, 2021
• Study Completion: August 31, 2021
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)