Chewing Gum Containing Vitamin-c to Treat Emesis Gravidarum

NCT04284696 | Completed DMC

• 1 other identifier: 1949-2019
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

Nausea and vomiting is a common complication of pregnancy and occurs in 70-80% of all pregnancies. The symptoms usually start 2-4 weeks after fertilization and peak between the 9th and 16th week of gestation. In the 22nd week of pregnancy, the symptoms usually resolve. In up to 10% of all pregnancies nausea and vomiting may persist until delivery, which is called emesis gravidarum. In 0.3-2% of all pregnancies, nausea and vomiting occur with a pathological intensity called hyperemesis gravidarum. The cause of nausea and vomiting during pregnancy is unknown, but it is believed that the stimulus is the placenta and not the fetus. Antihistamines have proven to be an effective therapy. Histamine is increasingly produced during pregnancy by mast cells in the endometrium and myometrium, but also by mast cells in the placenta and in the decidua. High expression of the histamine-producing enzyme histamine-decarboxylase (HDC) in the placenta and many histamine receptors at the feto-maternal transition in the decidua indicate a physiological role of the histamine during pregnancy. The antidote is diamine oxidase (DAO), which is produced in the decidua and trophoblast and breaks down histamine. DAO acts as a barrier to prevent excessive passage of histamine into the maternal and fetal circulation. DAO levels increase exponentially in the first 20 weeks of pregnancy to 1000 times the baseline before pregnancy. It has been shown that intravenous vitamin C significantly reduces blood histamine levels in both allergic and non-allergic disorders. Another study with the German Navy also proved that oral vitamin C administration can reduce nausea in seasickness. In an Australian study in 2016, it was shown that chewing gum was not inferior to ondansetron therapy in patients with postoperative nausea and vomiting (PONV). From the available literature, we conclude that high maternal histamine concentrations in early pregnancy may be a cause of nausea and vomiting, whereas DAO is not sufficiently expressed by the transfer of histamine from the decidua and trophoblast into the maternal circulation prevent. Vitamin C has been identified in controlled clinical trials as a way to lower blood histamine levels. Furthermore, chewing gum was already described as a treatment option for nausea and vomiting. The aim of this study is therefore to test whether chewing gum containing vitamin C in pregnant women with emesis gravidarum has the potential to reduce nausea and vomiting and to evaluate a possible association between maternal human chorionic gonadotropin (hCG) or histamine levels and the severity of nausea and vomiting in early pregnancy as well as the influence of other factors such as thyroxine and pyridoxine.

Conditions

Hyperemesis Gravidarum; Nausea Gravidarum; Vitamin C Deficiency

Outcome Measures

Primary Outcomes (1)

• Modified PUQE (Pregnancy-Unique Quantification of Emesis and Nausea) Score

  validated questionnaire describing individual nausea

  1 month

Secondary Outcomes (2)

• Level of diamine oxidase (DAO) serum concentratlon

  1 month

• Level of histamine serum concentration

  1 month

Study Arms (3)

Verum

ACTIVE COMPARATOR

patients with emesis gravidarum who take a chewing gum with vitamin C (verum) "ad libitum" several times daily for 2 weeks

Dietary Supplement: Pregnan-C-Gum(R) chewing gum

Placebo

PLACEBO COMPARATOR

patients with emesis gravidarum who take chewing gum without vitamin C (placebo) "ad libitum" several times daily for 2 weeks

Dietary Supplement: Placebo chewing gum

Nihil

NO INTERVENTION

patients with emesis gravidarum who do not use chewing gum during the study phase

Interventions

Pregnan-C-Gum(R) chewing gum DIETARY_SUPPLEMENT

Using a chewing gum with 150mg vitamin C (per piece/gum) for 14 days "ad libitum"

Verum

Placebo chewing gum DIETARY_SUPPLEMENT

Using a chewing gum without vitamin C (per piece/gum) for 14 days "ad libitum"

Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pregnancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥18 years
• singleton pregnancy
• signed information sheet
• symptoms of nausea and / or vomiting in early pregnancy
• no pre-existing medication for nausea and vomiting

You may not qualify if:

• age \<18 years
• multiple pregnancy
• patients with gastric band or in Z.n. bariatric surgery
• preexisting diabetes mellitus or gestational diabetes
• inability to consent to participation in the study
• already started therapy against the emesis gravidarum
• taking any antiemetic drugs during the study phase

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna, Dept. of Obstetrics and Gynecology

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Hyperemesis Gravidarum; Ascorbic Acid Deficiency

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

Morning Sickness; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vomiting; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Alex Farr, MD PhD

  Medical University of Vienna, Department of Obstetrics and Gynecology; Vienna General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Consultant Physician

Study Record Dates

• First Submitted: October 20, 2019
• First Posted: February 26, 2020
• Study Start: February 11, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)