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

NCT ID: NCT05098067

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-24
• Study Completion Date: 2023-03-01

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.

Conditions

Hyperemesis Gravidarum; Nausea Gravidarum; Vomiting of Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Capsaicin Topical Cream

Intervention Type: DRUG

5g 0.075% applied once

Metoclopramide

Intervention Type: DRUG

10mg IV once

Ondansetron

Intervention Type: DRUG

8mg IV once if needed

Lactated Ringers, Intravenous

Intervention Type: DRUG

1000cc once

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.

Group Type: PLACEBO_COMPARATOR

Metoclopramide

Intervention Type: DRUG

10mg IV once

Ondansetron

Intervention Type: DRUG

8mg IV once if needed

Lactated Ringers, Intravenous

Intervention Type: DRUG

1000cc once

Interventions

Capsaicin Topical Cream

5g 0.075% applied once

Intervention Type: DRUG

Metoclopramide

10mg IV once

Intervention Type: DRUG

Ondansetron

8mg IV once if needed

Intervention Type: DRUG

Lactated Ringers, Intravenous

1000cc once

Intervention Type: DRUG

Other Intervention Names

Reglan; Zofran

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Women and Infants Hospital of Rhode Island

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lauren Murphy, MD

Role: PRINCIPAL_INVESTIGATOR

Women and Infants Hospital

Locations

Women and Infants Hospital

Providence, Rhode Island, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Reference Type: DERIVED

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Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

1763191-1

Identifier Type: -

Identifier Source: org_study_id