Nausea, Pain
Conditions
Keywords
medical abortion, prophylactic use, nausea, pain, patient satisfaction
Brief summary
Randomized trial which will aim to evaluate whether prophylactic use of ondansetron and ibuprofen will decrease side effects associated with medical abortion and increase patient satisfaction.
Interventions
DRUGProphylactic use of ibuprofen and ondansetron post misoprostol administration
Prophylactic use of ibuprofen and ondansetron post misoprostol administration
DRUGUse of ibuprofen and ondansetron at symptom onset post misoprostol administration
Administration of ibuprofen or ondansetron only when experiencing pain or nausea respectively post misoprostol administration.
Sponsors
Hackensack Meridian Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy * English speaking * female volunteers undergoing medical abortion whether for voluntary interruption of pregnancy or missed abortion * Gestational age \</= 70 days confirmed via ultrasound * Access to a time keeping device * Willingness to complete a telephone or in-clinic follow up
Exclusion criteria
* chronic medical problems including but not limited to cardiac conditions, malignancy or organ damage * Failed medical abortion resulting in surgical management * Known intrauterine infection * Known allergy to ondansetron or ibuprofen * Subjects chronically receiving analgesic drugs * Subjects unable to give consent * Subjects taking medications that interact with ondansetron or ibuprofen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | At follow up visit, within 2 weeks from the administration of misoprostol | Determine if prophylactic use of ondansetron and ibuprofen during medical abortion treatment can increase patient satisfaction thereby creating a more favorable outcome. Patient satisfaction will be assessed using a home developed survey. Satisfaction is measured on 5-Likert scale ranging from Very satisfied to Very dissatisfied. |
| Patient Satisfaction Based on Recommendation of Regimen | At follow up visit, within 2 weeks from the administration of misoprostol | Determine if prophylactic use of ondansetron and ibuprofen during medical abortion treatment can increase patient satisfaction based on their likelihood to recommend the regimen. Likelihood to recommend will be assessed using a home developed survey measured on 5-Likert scale ranging from Extremely likely to recommend to Extremely unlikely to recommend (an additional I do not know option will be provided). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nausea Management | Within 6-8 hours from the administration of misoprostol | Evaluate for a satisfactory anti-nausea management regimen for medical abortion using a numerical nausea scale ranging from 1 to 10 with 1 being no nausea and 10 being very much nausea. |
| Pain Management at 6-8 Hours | Within 6-8 hours from the administration of misoprostol | Evaluate for a satisfactory pain management regimen for medical abortion using a numerical pain scale ranging from 1 to 10 with 1 being no pain and 10 being very much pain. |
| Need for Anti-nausea Medication. | Within 24 hours from the administration of misoprostol | Evaluate for a satisfactory anti-nausea management regimen for medical abortion based on the additional anti-nausea medication (Yes vs. No). |
| Need for Pain Management Medication. | Within 24 hours from the administration of misoprostol | Evaluate for a satisfactory pain management regimen for medical abortion based on the need for additional pain medication (Yes vs. No). |
| Pain Management at 24 Hours | Within 24 hours from the administration of misoprostol | Evaluate for a satisfactory pain management regimen for medical abortion using a numerical pain scale ranging from 1 to 10 with 1 being no pain and 10 being very much pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Administration of ibuprofen or ondansetron only when experiencing pain or nausea respectively post misoprostol administration.
Use of ibuprofen and ondansetron at symptom onset post misoprostol administration: Administration of ibuprofen or ondansetron only when experiencing pain or nausea respectively post misoprostol administration. | 3 |
| Prophylactic Use Administration of ibuprofen and ondansetron at the time of misoprostol administration.
Prophylactic use of ibuprofen and ondansetron post misoprostol administration: Prophylactic use of ibuprofen and ondansetron post misoprostol administration | 5 |
| Total | 8 |
Baseline characteristics
| Characteristic | Standard of Care | Prophylactic Use | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 5 Participants | 8 Participants |
| Age, Continuous | 29 years | 29 years | 29 years |
| Race/Ethnicity, Customized Central or South American | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Cuban | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Non Hispanic/Latino | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Other- Hispanic/Latino Hispanic/Latino | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 2 Participants | 2 Participants | 4 Participants |
| Region of Enrollment United States | 3 participants | 5 participants | 8 participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 8 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 / 3 | 0 / 5 |
| other Total, other adverse events | 0 / 3 | 0 / 5 |
| serious Total, serious adverse events | 0 / 3 | 0 / 5 |
Outcome results
Primary
Patient Satisfaction
Determine if prophylactic use of ondansetron and ibuprofen during medical abortion treatment can increase patient satisfaction thereby creating a more favorable outcome. Patient satisfaction will be assessed using a home developed survey. Satisfaction is measured on 5-Likert scale ranging from Very satisfied to Very dissatisfied.
Time frame: At follow up visit, within 2 weeks from the administration of misoprostol
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care | Patient Satisfaction | Very satisfied | 1 Participants |
| Standard of Care | Patient Satisfaction | Fairly satisfied | 2 Participants |
| Standard of Care | Patient Satisfaction | Neither satisfied nor dissatisfied | 0 Participants |
| Prophylactic Use | Patient Satisfaction | Very satisfied | 1 Participants |
| Prophylactic Use | Patient Satisfaction | Fairly satisfied | 2 Participants |
| Prophylactic Use | Patient Satisfaction | Neither satisfied nor dissatisfied | 1 Participants |
Primary
Patient Satisfaction Based on Recommendation of Regimen
Determine if prophylactic use of ondansetron and ibuprofen during medical abortion treatment can increase patient satisfaction based on their likelihood to recommend the regimen. Likelihood to recommend will be assessed using a home developed survey measured on 5-Likert scale ranging from Extremely likely to recommend to Extremely unlikely to recommend (an additional I do not know option will be provided).
Time frame: At follow up visit, within 2 weeks from the administration of misoprostol
Population: Patients who were part of the active cohort and got the prophylactic administration
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care | Patient Satisfaction Based on Recommendation of Regimen | Extremely unlikely to recommend | 0 Participants |
| Standard of Care | Patient Satisfaction Based on Recommendation of Regimen | I do not know | 0 Participants |
| Standard of Care | Patient Satisfaction Based on Recommendation of Regimen | Extremely likely to recommend | 1 Participants |
| Standard of Care | Patient Satisfaction Based on Recommendation of Regimen | Likely to recommend | 2 Participants |
| Standard of Care | Patient Satisfaction Based on Recommendation of Regimen | Neither likely nor unlikely to recommend | 1 Participants |
| Standard of Care | Patient Satisfaction Based on Recommendation of Regimen | Unlikely to recommend | 0 Participants |
Secondary
Nausea Management
Evaluate for a satisfactory anti-nausea management regimen for medical abortion using a numerical nausea scale ranging from 1 to 10 with 1 being no nausea and 10 being very much nausea.
Time frame: Within 6-8 hours from the administration of misoprostol
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care | Nausea Management | 4.33 score on a nausea scale |
| Prophylactic Use | Nausea Management | 4 score on a nausea scale |
Secondary
Nausea Management
Evaluate for a satisfactory anti-nausea management regimen for medical abortion using a numerical nausea scale ranging from 1 to 10 with 1 being no nausea and 10 being very much nausea.
Time frame: Within 24 hours from the administration of misoprostol
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care | Nausea Management | 3 score on a nausea scale |
| Prophylactic Use | Nausea Management | 1.2 score on a nausea scale |
Secondary
Need for Anti-nausea Medication.
Evaluate for a satisfactory anti-nausea management regimen for medical abortion based on the additional anti-nausea medication (Yes vs. No).
Time frame: Within 24 hours from the administration of misoprostol
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care | Need for Anti-nausea Medication. | Yes | 1 Participants |
| Standard of Care | Need for Anti-nausea Medication. | No | 2 Participants |
| Prophylactic Use | Need for Anti-nausea Medication. | Yes | 0 Participants |
| Prophylactic Use | Need for Anti-nausea Medication. | No | 5 Participants |
Secondary
Need for Pain Management Medication.
Evaluate for a satisfactory pain management regimen for medical abortion based on the need for additional pain medication (Yes vs. No).
Time frame: Within 24 hours from the administration of misoprostol
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care | Need for Pain Management Medication. | Yes | 3 Participants |
| Standard of Care | Need for Pain Management Medication. | No | 0 Participants |
| Prophylactic Use | Need for Pain Management Medication. | Yes | 2 Participants |
| Prophylactic Use | Need for Pain Management Medication. | No | 3 Participants |
Secondary
Pain Management at 24 Hours
Evaluate for a satisfactory pain management regimen for medical abortion using a numerical pain scale ranging from 1 to 10 with 1 being no pain and 10 being very much pain.
Time frame: Within 24 hours from the administration of misoprostol
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care | Pain Management at 24 Hours | 5 score on a pain scale |
| Prophylactic Use | Pain Management at 24 Hours | 4.8 score on a pain scale |
Secondary
Pain Management at 6-8 Hours
Evaluate for a satisfactory pain management regimen for medical abortion using a numerical pain scale ranging from 1 to 10 with 1 being no pain and 10 being very much pain.
Time frame: Within 6-8 hours from the administration of misoprostol
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care | Pain Management at 6-8 Hours | 7.66 score on a pain scale |
| Prophylactic Use | Pain Management at 6-8 Hours | 6.5 score on a pain scale |