Hyperemesis Gravidarum, Nausea Gravidarum, Vomiting of Pregnancy
Conditions
Keywords
capsaicin, nausea, vomiting, pregnancy, hyperemesis gravidarum
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.
Interventions
DRUGCapsaicin Topical Cream
5g 0.075% applied once
DRUGMetoclopramide
10mg IV once
DRUGOndansetron
8mg IV once if needed
1000cc once
Sponsors
Women and Infants Hospital of Rhode Island
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Symptom Control | 180 minutes | Time to perceived symptom control as measured by time elapsed between metoclopramide administration and patient request for discharge. |
Secondary
| Measure | Time frame |
|---|---|
| Number of Antiemetics Needed for Symptom Control | 180 minutes |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Capsaicin Topical Cream: 5g 0.075% applied once
Metoclopramide: 10mg IV once
Ondansetron: 8mg IV once if needed
Lactated Ringers, Intravenous: 1000cc once | 15 |
| 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.
Metoclopramide: 10mg IV once
Ondansetron: 8mg IV once if needed
Lactated Ringers, Intravenous: 1000cc once | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Total | Intervention Group | Placebo Group |
|---|---|---|---|
| Age, Continuous | 26.5 years | 24 years | 28 years |
| BMI | 23.4 kg/m^2 | 23.5 kg/m^2 | 22.9 kg/m^2 |
| Gestational age | 59.5 days | 68 days | 52 days |
| Parity | 1 deliveries | 1 deliveries | 1 deliveries |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Sex: Female, Male Female | 30 Participants | 15 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 10 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Time to Symptom Control
Time to perceived symptom control as measured by time elapsed between metoclopramide administration and patient request for discharge.
Time frame: 180 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group | Time to Symptom Control | 72 minutes |
| Placebo Group | Time to Symptom Control | 87 minutes |
Secondary
Number of Antiemetics Needed for Symptom Control
Time frame: 180 minutes
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Group | Number of Antiemetics Needed for Symptom Control | 2 additional antiemetics | 1 Participants |
| Intervention Group | Number of Antiemetics Needed for Symptom Control | 4 additional antiemetics | 0 Participants |
| Intervention Group | Number of Antiemetics Needed for Symptom Control | 3 additional antiemetics | 1 Participants |
| Intervention Group | Number of Antiemetics Needed for Symptom Control | 0 additional antiemetics | 11 Participants |
| Intervention Group | Number of Antiemetics Needed for Symptom Control | 1 additional antiemetic | 2 Participants |
| Placebo Group | Number of Antiemetics Needed for Symptom Control | 0 additional antiemetics | 10 Participants |
| Placebo Group | Number of Antiemetics Needed for Symptom Control | 1 additional antiemetic | 4 Participants |
| Placebo Group | Number of Antiemetics Needed for Symptom Control | 2 additional antiemetics | 1 Participants |
| Placebo Group | Number of Antiemetics Needed for Symptom Control | 3 additional antiemetics | 0 Participants |
| Placebo Group | Number of Antiemetics Needed for Symptom Control | 4 additional antiemetics | 0 Participants |