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

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

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

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island

  lead OTHER

Principal Investigators

• Lauren Murphy, MD · Women and Infants Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-05-24

Primary Completion

2022-10-17

Completion

2023-03-01

FDA Drug

Yes

Countries

• United States

Study Locations