Vitamin C Chewing Gum, Pregnancy Nausea and Vomiting (PregnancyNause)

January 30, 2024 updated by: Fatma Yildirim, Hitit University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Çorum, Turkey, 19600
        • Recruiting
        • Fatma Yıldırım
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Those who have a health problem that may cause nausea and vomiting in their current pregnancy,
  • Those receiving any antiemetic treatment,
  • Smokers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
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.
Experimental: Intervention group
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.
Other: Chewing gum with vitamin C
Will chew vitamin C gum as soon as nausea begins

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: 0-60-120. munites
It will be used to measure the severity of nausea and vomiting.
0-60-120. munites

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hitit University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 8, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 5, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Hitituniversity_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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