Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy

Last updated: February 5, 2024
Sponsor: Women and Infants Hospital of Rhode Island
Overall Status: Completed

Phase

2

Condition

Stomach Discomfort

Lactose Intolerance

Pregnancy Complications

Treatment

Capsaicin Topical Cream

Metoclopramide

Ondansetron

Clinical Study ID

NCT05098067
1763191-1
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

Between fifty and eighty percent of pregnant women experience nausea and vomiting in pregnancy making it one of the most common medical complications of pregnancy. Hyperemesis gravidarum is an extreme form of nausea and vomiting of pregnancy and results in evidence of acute starvation (i.e. large ketonuria), and weight loss (>5% of a woman's pre-pregnancy weight). Hyperemesis gravidarum is also surprisingly common. In fact, it is the second leading cause of preterm hospitalization during pregnancy, second only preterm labor. Hospitalization is often required because hyperemesis is frequently refractory to common anti-nausea medications. However, capsaicin cream, a potent TRPV1 agonist, commonly used to relieve muscular and neuropathic pain, may be able to reduce the symptoms of nausea and emesis in patients with nausea and vomiting of pregnancy. Smaller studies have demonstrated capsaicin to be both safe and effective when used to treat intraoperative nausea during cesarean delivery. To begin to address whether capsaicin cream could be used to reduce preterm admissions and shorten emergency room visits for hyperemesis, this study will randomize women presenting to the emergency room for nausea and vomiting to treatment with capsaicin cream as an adjunctive medication or routine care. The project will investigate the impact of capsaicin cream on hospital length of stay as well as representation for additional treatment. If effective, capsaicin cream has the potential not only to reduce emergency room visits, hospital admissions and overall health care costs, but also to drastically improve patient quality of life.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pregnant women in the first trimester (0-14 weeks gestation)
  • Presenting to the emergency room at Women & Infants Hospital in Rhode Island with achief complaint of nausea and vomiting
  • English or Spanish speaking
  • Have not taken an anti-emetic such as Reglan or Zofran within the 6 hours prior topresentation

Exclusion

Exclusion Criteria:

  • Allergy to Reglan, capsaicin or Zofran
  • Another identifiable source for nausea and vomiting (i.e. gastritis, COVID, diabeticketoacidosis)
  • Molar pregnancies,
  • Patients with a history of gastroparesis
  • Patients with a history of preexisting diabetes mellitus

Study Design

Total Participants: 30
Treatment Group(s): 4
Primary Treatment: Capsaicin Topical Cream
Phase: 2
Study Start date:
May 24, 2022
Estimated Completion Date:
March 01, 2023

Connect with a study center

  • Women and Infants Hospital

    Providence, Rhode Island 02906
    United States

    Site Not Available

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