Ignite Creation Date:
2024-05-06 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05098067
Status:
COMPLETED
Last Update Posted:
2024-02-07
First Post:
2021-10-20
Brief Title:
Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy
Sponsor:
Women and Infants Hospital of Rhode Island
Organization:
Women and Infants Hospital of Rhode Island
Study Overview
Official Title:
Trial of Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy A Pilot Investigation
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie large ketonuria and weight loss 5 of a womans 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None