NCT04191694

Brief 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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
284

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 28, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 3, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

4 months

First QC Date

December 3, 2019

Last Update Submit

January 21, 2020

Conditions

PONV

Outcome Measures

Primary Outcomes (2)

  • The difference in the number of episodes of self-reported nausea

    Self-reported nausea described to investigator

    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

    24 hours post caesarean section

Secondary Outcomes (4)

  • Episodes of nausea, vomiting or both in recovery room and at 24 hours after caesarean section.

    24 hours post caesarean section

  • Severity of nausea, reported as the worst episode in the last 24 hours

    24 hours post caesarean section

  • Antiemetics in the first 24 hours after Caesarean section under spinal anaesthesia

    24 hours post caesarean section

  • Patient satisfaction with the intervention

    24 hours post caesarean section

Study Arms (2)

Control

OTHER

Patients will receive the standard dose of anti-emetic according to hospital practice (Ondansetron 4mg IV, intra-operatively)

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.

Other: Chewing GumDrug: Ondansetron 4 MG

Interventions

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.

Chewing Gum
Ondansetron 4 MGDRUG

Ondansetron 4mg intravenously, intra-operatively as part of standard hospital caesarean section protocol

Chewing GumControl

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Coombe Women and Infants University Hospital

Dublin, Ireland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36404985DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Chewing GumOndansetron

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

Plant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex MixturesCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Officials

  • Terry Tan

    Coombe Women and Infants University Hospital

    STUDY DIRECTOR

Central Study Contacts

Petar Popivanov

CONTACT

014085662ppopivanov@coombe.ie

Terry Tan

CONTACT

014085662ttan@coombe.ie

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
Principal Investigator

Study Record Dates

First Submitted

December 3, 2019

First Posted

December 10, 2019

Study Start

October 28, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

January 23, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

IE(1)