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

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Women and Infants Hospital of Rhode Island
• Treatments: Capsaicin; Metoclopramide; Ondansetron

Criteria

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 a chief 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 to presentation

Exclusion Criteria:

• Allergy to Reglan, capsaicin or Zofran

• Another identifiable source for nausea and vomiting (i.e. gastritis, COVID, diabetic ketoacidosis)

• Molar pregnancies,

• Patients with a history of gastroparesis

• Patients with a history of preexisting diabetes mellitus