NCT05098067

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

Trial of Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy: A Pilot Investigation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Women and Infants Hospital of Rhode Island · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hyperemesis Gravidarum
• Nausea Gravidarum
• Vomiting of Pregnancy

Interventions

Type	Name	Description
DRUG	Capsaicin Topical Cream	5g 0.075% applied once
DRUG	Metoclopramide	10mg IV once
DRUG	Ondansetron	8mg IV once if needed
DRUG	Lactated Ringers, Intravenous	1000cc once

Timeline

• Start date: 2022-05-24
• Primary completion: 2022-10-17
• Completion: 2023-03-01
• First posted: 2021-10-28
• Last updated: 2024-02-07
• Results posted: 2024-02-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study