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

Sponsor
Women and Infants Hospital of Rhode Island (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05098067
Collaborator
(none)
30
2
22

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Trial of Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy: A Pilot Investigation
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

Participants will receive IV fluid bolus of 1000cc of lactated ringers, metoclopromide 10mg IV and will have 5g of 0.075% capsaicin cream applied to their abdomen. Participants will indicate the severity of their symptoms immediately prior to administration of metoclopromide, at time 0 and every 30 minutes for a total of 120 minutes after administration of the first medications (or discharge) using a 10 cm visual analogue scale (VAS)11,12. The scale will be provided in English or Spanish as appropriate. If at the 90-minute time mark the patient does not report improvement of their symptoms, odansetron 8mg IV will be administered.

Drug: Capsaicin Topical Cream
5g 0.075% applied once

Drug: Metoclopramide
10mg IV once
Other Names:
  • Reglan
  • Drug: Ondansetron
    8mg IV once if needed
    Other Names:
  • Zofran
  • Drug: Lactated Ringers, Intravenous
    1000cc once

    Placebo Comparator: Placebo group

    Participants will receive IV fluid bolus of 1000cc of lactated ringers, metoclopromide 10mg IV and will have 5g of placebo cream applied to their abdomen. Participants will indicate the severity of their symptoms immediately prior to administration of metoclopromide, at time 0 and every 30 minutes for a total of 120 minutes after administration of the first medications (or discharge) using a 10 cm visual analogue scale (VAS). The scale will be provided in English or Spanish as appropriate. If at the 90-minute time mark the patient does not report improvement of their symptoms, odansetron 8mg IV will be administered.

    Drug: Metoclopramide
    10mg IV once
    Other Names:
  • Reglan
  • Drug: Ondansetron
    8mg IV once if needed
    Other Names:
  • Zofran
  • Drug: Lactated Ringers, Intravenous
    1000cc once

    Outcome Measures

    Primary Outcome Measures

    1. Time to symptom control [180 minutes]

      Time to perceived symptom control as measured by a validated scale used to measure patient's perception of the severity of nausea and vomiting symptoms (i.e. VAS)

    Secondary Outcome Measures

    1. Number of antiemetics needed for symptom control [180 minutes]

    2. Length of emergency department stay [180 minutes]

      Time to discharge from the emergency department

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Women and Infants Hospital of Rhode Island

    Investigators

    • Principal Investigator: Lauren Murphy, MD, Women and Infants Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Women and Infants Hospital of Rhode Island
    ClinicalTrials.gov Identifier:
    NCT05098067
    Other Study ID Numbers:
    • 1763191-1
    First Posted:
    Oct 28, 2021
    Last Update Posted:
    Oct 28, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Women and Infants Hospital of Rhode Island
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 28, 2021