Vitamin C Chewing Gum, Pregnancy Nausea and Vomiting

NCT ID: NCT06246240

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-08
• Study Completion Date: 2024-03-05

Brief 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. 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).

Conditions

Pregnancy Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Chewing gum with vitamin C

Intervention Type: OTHER

Will chew vitamin C gum as soon as nausea begins

Interventions

Chewing gum with vitamin C

Will chew vitamin C gum as soon as nausea begins

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hitit University

OTHER

Sponsor Role: lead

Responsible Party

Fatma Yildirim

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fatma Yıldırım

Çorum, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Facility Contacts

Fatma Yıldırım

Role: primary

crazy_fotti@hotmail.com

+905466742445

Other Identifiers

Hitituniversity_1

Identifier Type: -

Identifier Source: org_study_id