Fluid tasting in patients with nausea and vomiting in pregnancy

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2019
INTERVENTION: Participants will be required to drink 4 types of fluids in random order. These fluids include water, ginger‐flavoured drink, orange juice and lemon drink (water and ginger‐flavored drink are compulsory, whereas orange juice and lemon drink are the 2 top ranking fluids based on the first part questionnaire). 1. Patient admitted to Gynecology ward UMMC with presumed diagnosis of hyperemesis gravidarum. 2. Screening of patient is done with the Eligibility Form (EF) and patients who fulfill the inclusion and exclusion criteria are approached for recruitment. 3. Patient will be provided with a Patient Information Sheet (PIS) and a verbal explanation of the study. 4. If the patient does not agree, they will be excluded from the recruitment and subsequent care will be according to standard treatment protocols. 5. Patients who agree to participate in the study will personally sign and date the Consent Form. 6. The participant will be interviewed by the investigator and Case Report Form (CRF) is filled up by the investigator. 7. Fluid tasting requires the swallowing of a liquid measured accurately with a syringe of 30 ml per serving in a standard 50ml disposable cup. 8. In the presence of the investigator, participants are required to take each drink, hold it for 3 seconds and rinse it in the mouth, then slowly swallow. This is repeated for the 4 fluid items in a randomly allocated order and observed for 10 minutes after each fluid item. 9. Participants will be required to rinse their mouth with plain water at the end of tasting each fluid item before proceeding to the next fluid item. Drinking plain water at any time during the tasting is allowed as well. 10. Participants will be asked to score the severity of their nausea in a visual numerical rating score from 0‐10. This scoring will be done bef CONDITION: Hyperemesis gravidarum ; Pregnancy and Childbirth ; Excessive vomiting in pregnancy PRIMARY OUTCOME: ; 1. Participant’s nausea score measured using a visual numerical rating scale from 0 to 10 before tasting (0 minutes), 2 and 10 minutes after tasting each fluid item; 2. 'Agreeability score’ on each fluid item measured using a visual numerical rating scale from 0 to 10 at 10 minutes; 3. Signs questions (S_Q) to each participant after tasting each fluid item at 10 minutes; SECONDARY OUTCOME: Observations of each participant after tasting each fluid item, i.e. whether they have any urge to vomit, heave or gag in 10 minutes after each fluid item is ingested INCLUSION CRITERIA: 1. Patients admitted with presumed diagnosis of hyperemesis gravidarum 2. Confirmed clinical pregnancy (at least a positive pregnancy test if gestational sac is not yet visible on ultrasound) 3. Gestation less than 16 weeks 4. Age 18 years old and above 5. Patient is within 24 hours of first admission in current pregnancy for hyperemesis gravidarum
Epistemonikos ID: f293956a0b5961402fac57e7c31dca22f534f0ca
First added on: Aug 24, 2024