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Intervention group for Hyperemesis Gravidarum
Phase 2
Waitlist Available
Led By Lauren Murphy, MD
Research Sponsored by Women and Infants Hospital of Rhode Island
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 minutes
Awards & highlights
Study Summary
This trialwill study if capsaicin cream, commonly used to relieve pain, can help reduce nausea & vomiting in pregnancy, reducing ER visits & hospitalizations.
Eligible Conditions
- Hyperemesis Gravidarum
- Morning Sickness
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 180 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to Symptom Control
Secondary outcome measures
Number of Antiemetics Needed for Symptom Control
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intervention groupExperimental Treatment4 Interventions
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.
Group II: Placebo groupPlacebo Group3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metoclopramide
FDA approved
Ondansetron
FDA approved
Capsaicin
FDA approved
Lactated Ringers, Intravenous
2022
Completed Phase 2
~30
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Who is running the clinical trial?
Women and Infants Hospital of Rhode IslandLead Sponsor
108 Previous Clinical Trials
38,510 Total Patients Enrolled
Lauren Murphy, MDPrincipal InvestigatorWomen and Infants Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had diabetes before starting the study.Your nausea and vomiting could be caused by something else, like inflammation of the stomach, COVID-19, or a medical condition called diabetic ketoacidosis.You have a past medical history of gastroparesis.You have not taken medication to prevent nausea, such as Reglan or Zofran, in the 6 hours before starting the study.You are allergic to Reglan, capsaicin or Zofran.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo group
- Group 2: Intervention group
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the safety implications associated with being a part of this intervention group?
"Due to the Phase 2 status of this treatment, and therefore limited data substantiating efficacy yet some evidence regarding safety, our team at Power has assigned it a score of two on the risk assessment scale."
Answered by AI
What is the participant recruitment rate for this clinical trial?
"Affirmative. Information posted on clinicaltrials.gov reveals that this study is now accepting participants, beginning May 24th 2022 and most recently updated October 17th 2022. The medical trial requires 30 patients to be recruited from one site."
Answered by AI
Are applications being accepted for this study at present?
"As per clinicaltrials.gov, this medical experimentation is actively enrolling volunteers, with the original posting date on May 24th 2022 and last modification occurring October 17th 2022."
Answered by AI
To what end are Intervention groups typically employed?
"Intervention group is frequently employed to manage gastroparesis, but has also been successfully used in treating acute nonspecific tenosynovitis, pharmacotherapy, and musculoskeletal pain."
Answered by AI
Who else is applying?
What state do they live in?
Rhode Island
What site did they apply to?
Women and Infants Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
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