Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy
Condition: Hyperemesis Gravidarum; Nausea Gravidarum; Vomiting of Pregnancy
MeSH terms: Hyperemesis Gravidarum; Pregnancy Complications; Nausea; Vomiting
Intervention: Capsaicin Topical Cream; Metoclopramide; Ondansetron; Lactated Ringers, Intravenous
Intervention description: 5g 0.075% applied once; 10mg IV once; 8mg IV once if needed; 1000cc once
Intervention MeSH terms: Ondansetron; Metoclopramide; Capsaicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 30.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: capsaicin; nausea; vomiting; pregnancy; hyperemesis gravidarum

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.
    

Eligibility 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