Clinical trial NCT06246240: Vitamin C Chewing Gum, Pregnancy Nausea and Vomiting
Official title: Effect of Vitamin C Chewing Gum on Pregnancy Nausea and Vomiting Severity: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Nausea and Vomiting
Lead sponsor: Hitit University
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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).

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.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 0-60-120. munites
Secondary outcomes:
Other outcomes:
Locations:
city: Çorum
country: Turkey
facility: Fatma Yıldırım
Study officials:
References: