Pregnancy Nausea and VomitingPregnancyNauseNCT06246240
Vitamin C Chewing Gum, Pregnancy Nausea and Vomiting
A study testing Chewing gum with vitamin C in people with Pregnancy Nausea and Vomiting, run by Hitit University at 1 site in Turkey (Türkiye).
Trial summary
Although there are studies in the literature examining the effects of chewing gum or using vitamin C on nausea and vomiting symptoms, no study has been found examining the effect of vitamin C gum on the severity of nausea and vomiting during pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Nausea and Vomiting
- What is being tested?
- Chewing gum with vitamin C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Oct 2023to 5 Mar 2024
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 years and over,
- At least primary school graduate,
- married,
- Those who are younger than the 16th week of pregnancy,
- Those who complain of nausea and vomiting during pregnancy,
- Those who agreed to participate in the study.
Who cannot join
- Those who have a health problem that may cause nausea and vomiting in their current pregnancy,
- Those receiving any antiemetic treatment,
- Smokers.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Fatma Yıldırım
Çorum, 19600
Fatma Yıldırım, +905466742445, crazy_fotti@hotmail.com
About this study
Official title: Effect of Vitamin C Chewing Gum on Pregnancy Nausea and Vomiting Severity: Randomized Controlled Study
Although there are studies in the literature examining the effects of chewing gum or using vitamin C on nausea and vomiting symptoms, no study has been found examining the effect of vitamin C gum on the severity of nausea and vomiting during pregnancy. This study aimed to investigate the effect of vitamin C gum on the severity of pregnancy nausea and vomiting.
Read the detailed description
One of the problems that occur during pregnancy, the etiology of which is not fully known, is nausea and vomiting experienced during early pregnancy (Taşkın, 2019). Meta-analysis studies indicate that the prevalence of nausea and vomiting during pregnancy is between 35% and 91% (Matthews et al., 2015; Sridharan and Sivaramakrishnan, 2018). Nausea and vomiting usually occur on days 4-6. It starts in weeks 9-16 of pregnancy. It peaks in the following weeks (Matthews et al., 2015). Risk factors for nausea and vomiting during pregnancy are not known precisely. While the increase in human chorionic gonadotropin hormone and estrogens in the blood seems to be the possible cause, hormonal factors such as prostaglandin E2, thyroxine and prolactin are probably added to this (Bustos et al., 2017). There are many pharmacological and non-pharmacological methods with proven effects in the treatment of pregnancy nausea and vomiting. Pharmacological treatments include antiemetics, anticholinergics, antihistamines, dopamine antagonists, vitamins (B6 and B12), H3 antagonists or combinations of these substances (Erişen et al., 2021). Non-pharmacological methods include some interventions such as acustimulation, acupuncture, chamomile, ginger, peppermint oil, lemon oil, and vitamin B6 (Matthews et al., 2015). Pregnant women with nausea and vomiting generally do not want to receive pharmacological treatment due to concerns about the negative effects of drugs on the fetus. It is stated that various vitamin-based products such as B6, B12 and herbal treatments such as ginger, mint, peppermint oil and lemon are effective and safe in pregnancy nausea and vomiting (Sarecka-Hujar and Szulc-Musioł, 2022).
- Conditions
- Pregnancy Nausea and Vomiting
- Being tested
- Chewing gum with vitamin C
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing gum with vitamin COther
Will chew vitamin C gum as soon as nausea begins
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The Personal Information Form will be applied to the control group without any intervention and they will be asked to score the VAS Scale at the time the nausea begins and the retests at 60 and 120 minutes. After the interview with the pregnant women, all pregnant women will be called 24-48 hours later and data will be collected by questioning the 60th and 120th minute VAS scores of nausea severity. |
| Intervention group | Experimental | After obtaining the consent of the pregnant women, the Personal Information Form and VAS scale were applied. The experimental group was asked to score the VAS scale as soon as nausea started and was practiced chewing vitamin C gum for 30-60 minutes. Pregnant women in the experimental group were asked to score the VAS scale at 60 and 120 minutes after chewing gum. Receives: Other: Chewing gum with vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
It will be used to measure the severity of nausea and vomiting.
Measured: 0-60-120. munites
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start8 Oct 2023
- Primary completion5 Jan 2024
- Study completion5 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Yildirim, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246240
- Sponsor's protocol ID
- Hitituniversity_1
- Acronym
- PregnancyNause
- Status last verified
- Jan 2024
- First submitted
- 30 Jan 2024
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin C Chewing Gum on Pregnancy Nausea and Vomiting Severity: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06246240
- Acronym / sponsor ID
- PregnancyNause / Hitituniversity_1
- Conditions
- Pregnancy Nausea and Vomiting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 8 Oct 2023 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 5 Mar 2024 (estimated)
- First posted
- 7 Feb 2024 (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.
Although there are studies in the literature examining the effects of chewing gum or using vitamin C on nausea and vomiting symptoms, no study has been found examining the effect of vitamin C gum on the severity of nausea and vomiting during pregnancy. This study aimed to investigate the effect of vitamin C gum on the severity of pregnancy nausea and vomiting.
Detailed description
One of the problems that occur during pregnancy, the etiology of which is not fully known, is nausea and vomiting experienced during early pregnancy (Taşkın, 2019). Meta-analysis studies indicate that the prevalence of nausea and vomiting during pregnancy is between 35% and 91% (Matthews et al., 2015; Sridharan and Sivaramakrishnan, 2018). Nausea and vomiting usually occur on days 4-6. It starts in weeks 9-16 of pregnancy. It peaks in the following weeks (Matthews et al., 2015). Risk factors for nausea and vomiting during pregnancy are not known precisely. While the increase in human chorionic gonadotropin hormone and estrogens in the blood seems to be the possible cause, hormonal factors such as prostaglandin E2, thyroxine and prolactin are probably added to this (Bustos et al., 2017). There are many pharmacological and non-pharmacological methods with proven effects in the treatment of pregnancy nausea and vomiting. Pharmacological treatments include antiemetics, anticholinergics, antihistamines, dopamine antagonists, vitamins (B6 and B12), H3 antagonists or combinations of these substances (Erişen et al., 2021). Non-pharmacological methods include some interventions such as acustimulation, acupuncture, chamomile, ginger, peppermint oil, lemon oil, and vitamin B6 (Matthews et al., 2015). Pregnant women with nausea and vomiting generally do not want to receive pharmacological treatment due to concerns about the negative effects of drugs on the fetus. It is stated that various vitamin-based products such as B6, B12 and herbal treatments such as ginger, mint, peppermint oil and lemon are effective and safe in pregnancy nausea and vomiting (Sarecka-Hujar and Szulc-Musioł, 2022).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The Personal Information Form will be applied to the control group without any intervention and they will be asked to score the VAS Scale at the time the nausea begins and the retests at 60 and 120 minutes. After the interview with the pregnant women, all pregnant women will be called 24-48 hours later and data will be collected by questioning the 60th and 120th minute VAS scores of nausea severity. |
| Intervention group | Experimental | Other: Chewing gum with vitamin CAfter obtaining the consent of the pregnant women, the Personal Information Form and VAS scale were applied. The experimental group was asked to score the VAS scale as soon as nausea started and was practiced chewing vitamin C gum for 30-60 minutes. Pregnant women in the experimental group were asked to score the VAS scale at 60 and 120 minutes after chewing gum. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18 years and over,
- At least primary school graduate,
- married,
- Those who are younger than the 16th week of pregnancy,
- Those who complain of nausea and vomiting during pregnancy,
Key exclusion criteria (3 listed)
- Those who have a health problem that may cause nausea and vomiting in their current pregnancy,
- Those receiving any antiemetic treatment,
- Smokers.
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 gum with vitamin CWill chew vitamin C gum as soon as nausea begins | Other | Intervention group |
Primary outcome
Visual Analog Scale
Time frame: 0-60-120. munites
It will be used to measure the severity of nausea and vomiting.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 with vitamin C in people with Pregnancy Nausea and Vomiting, run by Hitit University at 1 site in Turkey (Türkiye).
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 6 inclusion and 3 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 7 Feb 2024. 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 Turkey (Türkiye). 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 0-60-120. munites). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2024.