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

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ClinicalTrials.gov Identifier: NCT05098067
Recruitment Status : Not yet recruiting
First Posted : October 28, 2021
Last Update Posted : October 28, 2021
Sponsor:
Information provided by (Responsible Party):
Women and Infants Hospital of Rhode Island

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
Hyperemesis Gravidarum Nausea Gravidarum Vomiting of Pregnancy Drug: Capsaicin Topical Cream Drug: Metoclopramide Drug: Ondansetron Drug: Lactated Ringers, Intravenous Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : December 1, 2021
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine


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 Name: Reglan

Drug: Ondansetron
8mg IV once if needed
Other Name: 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 Name: Reglan

Drug: Ondansetron
8mg IV once if needed
Other Name: Zofran

Drug: Lactated Ringers, Intravenous
1000cc once




Primary Outcome Measures :
  1. Time to symptom control [ Time Frame: 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 [ Time Frame: 180 minutes ]
  2. Length of emergency department stay [ Time Frame: 180 minutes ]
    Time to discharge from the emergency department



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05098067


Contacts
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Contact: Lauren Murphy, MD 210-722-2589 lmmurphy@wihri.org
Contact: Maureen Hamel, MD 508-479-9190 mhamel@kentri.org

Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
Investigators
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Principal Investigator: Lauren Murphy, MD Women and Infants Hospital
Additional Information:
Publications:

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Responsible Party: Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT05098067    
Other Study ID Numbers: 1763191-1
First Posted: October 28, 2021    Key Record Dates
Last Update Posted: October 28, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
capsaicin
nausea
vomiting
pregnancy
hyperemesis gravidarum
Additional relevant MeSH terms:
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Hyperemesis Gravidarum
Pregnancy Complications
Nausea
Vomiting
Signs and Symptoms, Digestive
Morning Sickness
Ondansetron
Metoclopramide
Capsaicin
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents
Sensory System Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents