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OpenTrials
Completed

NCT Number: NCT05098067

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Women and Infants Hospital

Providence, Rhode Island, 02906, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capsaicin Topical Cream

Drug

5g 0.075% applied once

Metoclopramide

Drug

10mg IV once

Other names: Reglan

ondansetron

Drug

8mg IV once if needed

Other names: Zofran

Lactated Ringers, Intravenous

Drug

1000cc once

Primary outcomes

  1. Time to Symptom Control

    Time frame: 180 minutes

    Time to perceived symptom control as measured by time elapsed between metoclopramide administration and patient request for discharge.

Secondary outcomes

  1. Number of Antiemetics Needed for Symptom Control

    Time frame: 180 minutes

Sponsors and collaborators

Lead sponsor

Women and Infants Hospital of Rhode Island

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Oct 28, 2021
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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