Last updated: February 5, 2024
Sponsor: Women and Infants Hospital of Rhode Island
Overall Status: Completed
Phase
2
Condition
Stomach Discomfort
Lactose Intolerance
Pregnancy Complications
Treatment
Capsaicin Topical Cream
Metoclopramide
Ondansetron
Clinical Study ID
NCT05098067
1763191-1
Ages > 18 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 achief 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 topresentation
Exclusion
Exclusion Criteria:
- Allergy to Reglan, capsaicin or Zofran
- Another identifiable source for nausea and vomiting (i.e. gastritis, COVID, diabeticketoacidosis)
- Molar pregnancies,
- Patients with a history of gastroparesis
- Patients with a history of preexisting diabetes mellitus
Study Design
Total Participants: 30
Treatment Group(s): 4
Primary Treatment: Capsaicin Topical Cream
Phase: 2
Study Start date:
May 24, 2022
Estimated Completion Date:
March 01, 2023
Connect with a study center
Women and Infants Hospital
Providence, Rhode Island 02906
United StatesSite Not Available
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