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Chewing Gum Containing Vitamin-c to Treat Emesis Gravidarum

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ClinicalTrials.gov Identifier: NCT04284696
Recruitment Status : Recruiting
First Posted : February 26, 2020
Last Update Posted : February 17, 2021
Sponsor:
Information provided by (Responsible Party):
Alex Farr, MD PhD, Medical University of Vienna

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.

Condition or disease Intervention/treatment Phase
Hyperemesis Gravidarum Nausea Gravidarum Vitamin C Deficiency Dietary Supplement: Pregnan-C-Gum(R) chewing gum Dietary Supplement: Placebo chewing gum Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Chewing Gum Containing Vitamin-c to Treat Emesis Gravidarum: a Randomized Controlled Trial
Actual Study Start Date : February 11, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Verum
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
Using a chewing gum with 150mg vitamin C (per piece/gum) for 14 days "ad libitum"

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

No Intervention: Nihil
patients with emesis gravidarum who do not use chewing gum during the study phase



Primary Outcome Measures :
  1. Modified PUQE (Pregnancy-Unique Quantification of Emesis and Nausea) Score [ Time Frame: 1 month ]
    validated questionnaire describing individual nausea


Secondary Outcome Measures :
  1. Level of diamine oxidase (DAO) serum concentratlon [ Time Frame: 1 month ]
    maybe an antidot of nausea and vomiting

  2. Level of histamine serum concentration [ Time Frame: 1 month ]
    maybe a cause of nausea and vomiting



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnancy
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04284696


Contacts
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Contact: Alex Farr, MD PhD +4314040028220 alex.farr@meduniwien.ac.at
Contact: Philipp Foessleitner, MD BSc +4314040028220 philipp.foessleitner@meduniwien.ac.at

Locations
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Austria
Medical University of Vienna, Dept. of Obstetrics and Gynecology Recruiting
Vienna, Austria, 1090
Contact: Philipp Foessleitner, MD BSc    +43140400 ext 28220    philipp.foessleitner@muv.ac.at   
Contact: Alex Farr, MD PhD    +43140400 ext 28220    alex.farr@muv.ac.at   
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Alex Farr, MD PhD Medical University of Vienna, Department of Obstetrics and Gynecology; Vienna General Hospital
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Responsible Party: Alex Farr, MD PhD, Assistant Professor, Consultant Physician, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT04284696    
Other Study ID Numbers: 1949-2019
First Posted: February 26, 2020    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperemesis Gravidarum
Scurvy
Ascorbic Acid Deficiency
Signs and Symptoms, Digestive
Morning Sickness
Pregnancy Complications
Vomiting
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases