PONVNCT04191694
Chewing Gum to Prevent Nausea and Vomiting After Caesarean Section Under Spinal Anaesthesia
A study testing Chewing Gum and Ondansetron 4 MG in people with PONV, run by Coombe Women and Infants University Hospital at 1 site in Ireland.
Trial summary
Our study aims to determine if there is a difference in a self-reported incidence of nausea and vomiting in women who are given chewing gum following elective caesarean section under spinal anaesthesia compared to those who do not receive chewing gum Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- PONV
- What is being tested?
- Chewing Gum and Ondansetron 4 MG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteIreland
- Study dates
- 28 Oct 2019to 1 Mar 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Spinal Anaesthesia
- Elective
- Able and Agreeable to chew chewing gum in recovery room and in the first 24 hours
- Received Ondansetron 4mg IV intra-operatively
Who cannot join
- Type 1 Diabetes Mellitus
- Nausea and/or Vomiting on arrival to recovery room
- Post-partum haemorrhage >1000ml
- Ergometrine or Misoprostol intra-operatively
- Intravenous opioid intra-operatively
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Coombe Women and Infants University Hospital
Dublin
Petar Popivanov, 014085200
About this study
Official title: Chewing Gum for Prevention of Nausea and Vomiting After Elective Caesarean Section Under Spinal Anaesthesia: A Randomised Controlled Trial
Our study aims to determine if there is a difference in a self-reported incidence of nausea and vomiting in women who are given chewing gum following elective caesarean section under spinal anaesthesia compared to those who do not receive chewing gum
Read the detailed description
Caesarean section is one of the most commonly performed surgical procedures worldwide and the rate continues to rise. It is most often performed under regional anaesthesia, like spinal or epidural with long acting opioids such as spinal morphine added to improve postoperative pain in the first 24 hours.
However, nausea and vomiting is a common side effect of spinal morphine. Other risk factors for nausea and vomiting are patient related (female, non-smoker, history of post-operative nausea and vomiting [PONV] and/or motion sickness) and surgery related (spinal induced hypotension, blood loss, vagal stimulation, uterine exteriorisation, uterotonics, i.v. opioids etc). Risk assessment tools are available to estimate the risk of PONV for each patient.
The incidence of post-caesarean section nausea and vomiting at Coombe Women and Infants University Hospital is 28% and worldwide rates range from 21%-79%.
In the context of Enhanced Recovery After Surgery (ERAS), experiencing nausea and vomiting is distressing, reduces patient satisfaction by delaying early eating, drinking and mobilisation, interrupts bonding with the baby and prolongs hospital discharge.
It has been demonstrated that chewing gum is not inferior to 4 mg Ondansetron in treating nausea and vomiting post breast and laparoscopic surgery in female patients. It also has been shown to improve the return of gastrointestinal function after major surgery.
To our knowledge, no study has assessed the role of chewing gum for preventing nausea and vomiting after caesarean section under spinal anaesthetic.
Our study aims to assess whether or not chewing gum helps to reduce the self-reported incidence of nausea and vomiting in women undergoing caesarean section under spinal anaesthesia when compared to a control group who will not receive chewing gum.
There will be two arms of our study. Both arms will receive as standard Ondansetron 4mg intra-operatively.
One arm, the intervention arm, will then receive chewing gum, initially in the recovery room after their procedure and then will receive chewing gum to chew over the first 24 hours after their procedure according to their preference.
The second arm will not receive the chewing gum intervention.
Each arm will be followed up in the theatre recovery room after their procedure - determining any episodes of nausea or vomiting in the recovery room and the severity of episodes and whether any anti-emetic was given.
Each arm will also be followed up 24 hours later, asking them to report the number of episodes of nausea or vomiting they experienced in the 24 hours following their caesarean section and to assign the severity of their nausea or vomiting a number between 0-10,0 being none, 10 being most severe. The intervention arm will be asked how long they chewed chewing gum for in the first 24 hours after their procedure. The intervention arm will also be asked to rate their satisfaction with the intervention on a scale of 0-10, 0 being not satisfied, 10 being extremely satisfied.
All patients undergoing caesarean section will be considered for selection.
Patients will be identified at the pre-assessment clinic. At this review, patients will be identified for screening and will be assessed for eligibility.
The study will be discussed with them and they will be given a patient information leaflet.
Informed consent will be obtained prior to any study related procedures being undertaken.
The participants will be given a patient information leaflet prior to consent being taken. The information leaflet will be provided in simple and clear language. All patients will be informed of the objectives, benefits, risks and obligations imposed by the study. This discussion and consent will be performed in the pre-assessment clinic, thus allowing sufficient time to contemplate participation in the trial. Any questions or concerns will be addressed prior to consent being obtained. Informed consent will be obtained by an anaesthetic registrar on admission to hospital.
The study will be investigator led, single centre, randomised, unblind double arm comparator study
- Conditions
- PONV
- Being tested
- Chewing Gum, Ondansetron 4 MG
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing GumOther
Patients will be given a packet of chewing gum on arrival in the post-operative recovery room. They will be asked to start chewing gum in the recovery room and then asked to chew gum according to their preference over course of the following 24 hours.
Ondansetron 4 MGDrug
Ondansetron 4mg intravenously, intra-operatively as part of standard hospital caesarean section protocol
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Patients will receive the standard dose of anti-emetic according to hospital practice (Ondansetron 4mg IV, intra-operatively) Receives: Drug: Ondansetron 4 MG |
| Chewing Gum | Active comparator | Patients will receive the standard dose of anti-emetic according to hospital practice (Ondansetron 4mg IV, intra-operatively) they will also receive chewing in the recovery room and on the post-natal ward. Receives: Other: Chewing Gum; Drug: Ondansetron 4 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the number of episodes of self-reported nausea
Self-reported nausea described to investigator
Measured: 24 hours post caesarean section
The difference in the number of episodes of self-reported vomiting
Self-reported number of episodes of vomiting described to investigator
Measured: 24 hours post caesarean section
Secondary outcomes (4)
Episodes of nausea, vomiting or both in recovery room and at 24 hours after caesarean section.
Number of episodes of nausea or vomiting experienced by women
Measured: 24 hours post caesarean section
Severity of nausea, reported as the worst episode in the last 24 hours
Severity on a scale from 0-10, 0 being no nausea, 10 being extremely severe
Measured: 24 hours post caesarean section
Antiemetics in the first 24 hours after Caesarean section under spinal anaesthesia
Number of doses of anti-emetic medication and the type of antiemetic given to women following their caesarean sections
Measured: 24 hours post caesarean section
Patient satisfaction with the intervention
Patient satisfaction on 0 - 10 scale and Patient Reported Outcome Measure (PROM) - Obstetric Quality of Recovery (ObsQoR-11), currently part of the routine pain round
Measured: 24 hours post caesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start28 Oct 2019
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PONVStudies 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
- 284 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coombe Women and Infants University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petar Popivanov, Coombe Women and Infants University Hospital
- Investigators
- Terry Tan, Study director, Coombe Women and Infants University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191694
- Sponsor's protocol ID
- 17-2019
- Status last verified
- Jan 2020
- First submitted
- 3 Dec 2019
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bowe R, Irwin R, Browne G, Harbison M, Gallen S, Yore PJ, MacGearailt E, Popivanov P, Tan T. Chewing Gum for Prevention of Nausea and Vomiting After Elective Caesarean Section: a Pilot Randomised Controlled Trial. SN Compr Clin Med. 2022;4(1):257. doi: 10.1007/s42399-022-01332-9. Epub 2022 Nov 14.
PubMed 36404985
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chewing Gum for Prevention of Nausea and Vomiting After Elective Caesarean Section Under Spinal Anaesthesia: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04191694
- Acronym / sponsor ID
- 17-2019
- Conditions
- PONV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 284 participants (estimated)
- Lead sponsor
- Coombe Women and Infants University HospitalUniversity, hospital or other
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 10 Dec 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.
Our study aims to determine if there is a difference in a self-reported incidence of nausea and vomiting in women who are given chewing gum following elective caesarean section under spinal anaesthesia compared to those who do not receive chewing gum
Detailed description
Caesarean section is one of the most commonly performed surgical procedures worldwide and the rate continues to rise. It is most often performed under regional anaesthesia, like spinal or epidural with long acting opioids such as spinal morphine added to improve postoperative pain in the first 24 hours.
However, nausea and vomiting is a common side effect of spinal morphine. Other risk factors for nausea and vomiting are patient related (female, non-smoker, history of post-operative nausea and vomiting [PONV] and/or motion sickness) and surgery related (spinal induced hypotension, blood loss, vagal stimulation, uterine exteriorisation, uterotonics, i.v. opioids etc). Risk assessment tools are available to estimate the risk of PONV for each patient.
The incidence of post-caesarean section nausea and vomiting at Coombe Women and Infants University Hospital is 28% and worldwide rates range from 21%-79%.
In the context of Enhanced Recovery After Surgery (ERAS), experiencing nausea and vomiting is distressing, reduces patient satisfaction by delaying early eating, drinking and mobilisation, interrupts bonding with the baby and prolongs hospital discharge.
It has been demonstrated that chewing gum is not inferior to 4 mg Ondansetron in treating nausea and vomiting post breast and laparoscopic surgery in female patients. It also has been shown to improve the return of gastrointestinal function after major surgery.
To our knowledge, no study has assessed the role of chewing gum for preventing nausea and vomiting after caesarean section under spinal anaesthetic.
Our study aims to assess whether or not chewing gum helps to reduce the self-reported incidence of nausea and vomiting in women undergoing caesarean section under spinal anaesthesia when compared to a control group who will not receive chewing gum.
There will be two arms of our study. Both arms will receive as standard Ondansetron 4mg intra-operatively.
One arm, the intervention arm, will then receive chewing gum, initially in the recovery room after their procedure and then will receive chewing gum to chew over the first 24 hours after their procedure according to their preference.
The second arm will not receive the chewing gum intervention.
Each arm will be followed up in the theatre recovery room after their procedure - determining any episodes of nausea or vomiting in the recovery room and the severity of episodes and whether any anti-emetic was given.
Each arm will also be followed up 24 hours later, asking them to report the number of episodes of nausea or vomiting they experienced in the 24 hours following their caesarean section and to assign the severity of their nausea or vomiting a number between 0-10,0 being none, 10 being most severe. The intervention arm will be asked how long they chewed chewing gum for in the first 24 hours after their procedure. The intervention arm will also be asked to rate their satisfaction with the intervention on a scale of 0-10, 0 being not satisfied, 10 being extremely satisfied.
All patients undergoing caesarean section will be considered for selection.
Patients will be identified at the pre-assessment clinic. At this review, patients will be identified for screening and will be assessed for eligibility.
The study will be discussed with them and they will be given a patient information leaflet.
Informed consent will be obtained prior to any study related procedures being undertaken.
The participants will be given a patient information leaflet prior to consent being taken. The information leaflet will be provided in simple and clear language. All patients will be informed of the objectives, benefits, risks and obligations imposed by the study. This discussion and consent will be performed in the pre-assessment clinic, thus allowing sufficient time to contemplate participation in the trial. Any questions or concerns will be addressed prior to consent being obtained. Informed consent will be obtained by an anaesthetic registrar on admission to hospital.
The study will be investigator led, single centre, randomised, unblind double arm comparator study
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Drug: Ondansetron 4 MGPatients will receive the standard dose of anti-emetic according to hospital practice (Ondansetron 4mg IV, intra-operatively) |
| Chewing Gum | Active comparator | Other: Chewing Gum, Drug: Ondansetron 4 MGPatients will receive the standard dose of anti-emetic according to hospital practice (Ondansetron 4mg IV, intra-operatively) they will also receive chewing in the recovery room and on the post-natal ward. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Spinal Anaesthesia
- Elective
- Able and Agreeable to chew chewing gum in recovery room and in the first 24 hours
- Received Ondansetron 4mg IV intra-operatively
Key exclusion criteria (5 listed)
- Type 1 Diabetes Mellitus
- Nausea and/or Vomiting on arrival to recovery room
- Post-partum haemorrhage >1000ml
- Ergometrine or Misoprostol intra-operatively
- Intravenous opioid intra-operatively
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 |
|---|---|---|
| Chewing GumPatients will be given a packet of chewing gum on arrival in the post-operative recovery room. They will be asked to start chewing gum in the recovery room and then asked to chew gum according to their preference over course of the following 24 hours. | Other | Chewing Gum |
| Ondansetron 4 MGOndansetron 4mg intravenously, intra-operatively as part of standard hospital caesarean section protocol | Drug | Chewing Gum, Control |
Primary outcome
The difference in the number of episodes of self-reported nausea
Time frame: 24 hours post caesarean section
Self-reported nausea described to investigator
The difference in the number of episodes of self-reported vomiting
Time frame: 24 hours post caesarean section
Self-reported number of episodes of vomiting described to investigator
4 secondary outcomes
Episodes of nausea, vomiting or both in recovery room and at 24 hours after caesarean section.
Time frame: 24 hours post caesarean section
Severity of nausea, reported as the worst episode in the last 24 hours
Time frame: 24 hours post caesarean section
Antiemetics in the first 24 hours after Caesarean section under spinal anaesthesia
Time frame: 24 hours post caesarean section
Patient satisfaction with the intervention
Time frame: 24 hours post caesarean section
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Derived from this study: PubMed 36404985Bowe R, Irwin R, Browne G, Harbison M, Gallen S, Yore PJ, MacGearailt E, Popivanov P, Tan T. Chewing Gum for Prevention of Nausea and Vomiting After Elective Caesarean Section: a Pilot Randomised Controlled Trial. SN Compr Clin Med. 2022;4(1):257. doi: 10.1007/s42399-022-01332-9. Epub 2022 Nov 14.
- 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.
Terry Tan study director
Coombe Women and Infants University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chewing Gum and Ondansetron 4 MG in people with PONV, run by Coombe Women and Infants University Hospital at 1 site in Ireland.
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 4 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 23 Jan 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 Ireland. 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 Petar Popivanov (014085662, ppopivanov@coombe.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in the number of episodes of self-reported nausea (time frame: 24 hours post caesarean section). 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 NCT04191694, which also lists 1 linked publication.
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 23 Jan 2020.