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

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: Recruiting
• Conditions: Pregnancy Nausea and Vomiting
• Intervention / Treatment: Other: Chewing gum with vitamin C

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: Interventional
• Enrollment (Estimated): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Çorum, Turkey, 19600
    • Recruiting
    • Fatma Yıldırım
    • Contact: Fatma Yıldırım; Phone Number: +905466742445; Email: crazy_fotti@hotmail.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	It will be used to measure the severity of nausea and vomiting.	0-60-120. munites

Collaborators and Investigators

• Sponsor: Hitit University

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2023
• Primary Completion (Actual): January 5, 2024
• Study Completion (Estimated): March 5, 2024

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting
• Other Study ID 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