Postoperative Nausea and VomitingPOC-NaVoPNCT04069806
Preoperative Oral Carbohydrate for Nausea and Vomiting Prevention During Cesarian Section
A study testing preoperative oral carbohydrate, preOp in people with Postoperative Nausea and Vomiting, run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- preoperative oral carbohydrate, preOp
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 sitePoland
- Study dates
- 3 Sep 2019to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >=18 years.
- Scheduled for an elective cesarean section.
- Uncomplicated pregnancy.
- Planned for spinal anesthesia.
- ASA I or ASA II.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Arleta Wojciechowska, RN contact
Poland1 site, 1 recruiting
- Recruiting
Pomeranian Medical University
Szczecin, 70-111
Katarzyna L Kotfis, MD, 0048914661144, katarzyna.kotfis@pum.edu.pl
About this study
Official title: An Analysis of Risk Factors and Implementation of Strategies to Prevent Nausea and Vomiting in Patients Undergoing Regional Anesthesia for Caesarean Section
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.
Read the detailed description
Post-operative nausea and vomiting (PONV) in women undergoing subarachnoid anesthesia for Caesarean section is an important clinical problem. Known mechanisms underlying PONV are based on prolonged fasting, hypotension due to concomitant sympatholysis during anesthesia, bradycardia due to increased vagal tone, visceral stimulation during surgery and intrathecal administered opioids. However, the identification of patients exposed to this problem and appropriate perioperative preparation is of key importance. An analysis of risk factors for postoperative nausea and vomiting in patients undergoing elective cesarean section under spinal anesthesia is of major clinical importance. The aim of this study is a comparison of the effectiveness of oral carbohydrate loading strategy as compared with standard pre-operative fasting in patients undergoing elective cesarean section under spinal anesthesia on the incidence and severity of PONV and biochemical parameters indicating ketosis.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- preoperative oral carbohydrate, preOp
- Keywords
- Nausea, Vomiting, Oral carbohydrate, Fasting
- Medical subject headings
- Postoperative Nausea and Vomiting, Nausea, Vomiting, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative oral carbohydrate, preOpDietary supplement
Patients in the experimental arm will receive oral carbohydrate preparation at 2 hours prior to planned caesarian section.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative oral carbohydrate load | Experimental | 6 hours for solid food and 2 hours for liquids + oral carbohydrate preparation 2 hours prior to surgery. Receives: Dietary Supplement: preoperative oral carbohydrate, preOp |
| Standard preoperative fasting | No intervention | 6 hours for solid food and 2 hours for liquids. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 24 hours
Secondary outcomes (6)
Time to first peristalsis.
Moment of first peristalsis after operation (in hours).
Measured: 24 hours
Time to first bowel movement.
Moment of first bowel movement after operation (in hours).
Measured: 24 hours
Concentration of serum lactate in serum.
Lactate level measured in maternal serum.
Measured: 0 hours
Concentration of beta-hydroxy-butiric acid in serum.
Beta-hydroxy-butiric acid level measured in maternal serum.
Measured: 0 hours
Insulin resistance factor (HOMA-IR).
Insulin resistance measured in maternal serum.
Measured: 0 hours
Concentration of isoprostane in urine.
Isoprostane level measured in maternal urine.
Measured: 0 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start3 Sep 2019
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katarzyna Kotfis, Pomeranian Medical University Szczecin
- Investigators
- Katarzyna L Kotfis, MD, PhD, Principal investigator, Pomeranian Medical UniversitySebastian Kwiatkowski, MD, PhD, Study chair, Pomeranian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069806
- Sponsor's protocol ID
- PUM_08.08.2019
- Acronym
- POC-NaVoP
- Status last verified
- Sep 2020
- First submitted
- 23 Aug 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40348958Kotfis 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.
PubMed 37568381
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Analysis of Risk Factors and Implementation of Strategies to Prevent Nausea and Vomiting in Patients Undergoing Regional Anesthesia for Caesarean Section
- ClinicalTrials.gov ID
- NCT04069806
- Acronym / sponsor ID
- POC-NaVoP / PUM_08.08.2019
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Nausea, Vomiting, Oral carbohydrate, Fasting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Post-operative nausea and vomiting (PONV) in women undergoing subarachnoid anesthesia for Caesarean section is an important clinical problem. Known mechanisms underlying PONV are based on prolonged fasting, hypotension due to concomitant sympatholysis during anesthesia, bradycardia due to increased vagal tone, visceral stimulation during surgery and intrathecal administered opioids. However, the identification of patients exposed to this problem and appropriate perioperative preparation is of key importance. An analysis of risk factors for postoperative nausea and vomiting in patients undergoing elective cesarean section under spinal anesthesia is of major clinical importance. The aim of this study is a comparison of the effectiveness of oral carbohydrate loading strategy as compared with standard pre-operative fasting in patients undergoing elective cesarean section under spinal anesthesia on the incidence and severity of PONV and biochemical parameters indicating ketosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative oral carbohydrate load | Experimental | Dietary Supplement: preoperative oral carbohydrate, preOp6 hours for solid food and 2 hours for liquids + oral carbohydrate preparation 2 hours prior to surgery. |
| Standard preoperative fasting | No intervention | –6 hours for solid food and 2 hours for liquids. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >=18 years.
- Scheduled for an elective cesarean section.
- Uncomplicated pregnancy.
- Planned for spinal anesthesia.
- ASA I or ASA II.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preoperative oral carbohydrate, preOpPatients in the experimental arm will receive oral carbohydrate preparation at 2 hours prior to planned caesarian section. | Dietary supplement | Preoperative oral carbohydrate load |
Primary outcome
Postoperative nausea and vomiting 6 hours after caesarian section.
Time frame: 6 hours
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).
Postoperative nausea and vomiting 24 hours after caesarian section.
Time frame: 24 hours
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).
6 secondary outcomes
Time to first peristalsis.
Time frame: 24 hours
Time to first bowel movement.
Time frame: 24 hours
Concentration of serum lactate in serum.
Time frame: 0 hours
Concentration of beta-hydroxy-butiric acid in serum.
Time frame: 0 hours
Insulin resistance factor (HOMA-IR).
Time frame: 0 hours
Concentration of isoprostane in urine.
Time frame: 0 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Derived from this study: PubMed 40348958Kotfis 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.
- Derived from this study: PubMed 37568381Kotfis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arleta Wojciechowska, RN contact
Katarzyna L Kotfis, MD, PhD principal investigator
Pomeranian Medical University
Sebastian Kwiatkowski, MD, PhD study chair
Pomeranian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preoperative oral carbohydrate, preOp in people with Postoperative Nausea and Vomiting, run by Pomeranian Medical University Szczecin at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katarzyna L Kotfis, MD, PhD (0048914661144, katarzyna.kotfis@pum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative nausea and vomiting 6 hours after caesarian section. (time frame: 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04069806, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.