An Early Phase 1 interventional study of Prophylactic use of ibuprofen and ondansetron post misoprostol administration and Use of ibuprofen and ondansetron at symptom onset post misoprostol administration in Nausea and Pain, sponsored by Hackensack Meridian Health. Terminated at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-17.
Sponsored by Hackensack Meridian Health · Early Phase 1, Interventional, and Prevention
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.
822 studies on the registry are indexed under Nausea; 104 are open to participants now.
This study's enrollment of 8 is below the median of 115 across 703 interventional studies indexed under Nausea.
Browse Nausea studies →Hackensack Meridian Health is the lead sponsor of 111 studies on the registry; 28 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 11 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Administration of ibuprofen or ondansetron only when experiencing pain or nausea respectively post misoprostol administration.
Drug: Use of ibuprofen and ondansetron at symptom onset post misoprostol administration
Administration of ibuprofen and ondansetron at the time of misoprostol administration.
Drug: Prophylactic use of ibuprofen and ondansetron post misoprostol administration
Prophylactic use of ibuprofen and ondansetron post misoprostol administration
Administration of ibuprofen or ondansetron only when experiencing pain or nausea respectively post misoprostol administration.
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
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
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
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
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
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
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
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
| Milestone | Standard of Care | Prophylactic Use |
|---|---|---|
| Started | 3 | 5 |
| Completed | 0 | 3 |
| Not completed | 3 | 2 |
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.
| Participants | Standard of Care | Prophylactic Use |
|---|---|---|
| Very satisfied | 1 | 1 |
| Fairly satisfied | 2 | 2 |
| Neither satisfied nor dissatisfied | 0 | 1 |
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).
| Participants | Prophylactic Group |
|---|---|
| Extremely likely to recommend | 1 |
| Likely to recommend | 2 |
| Neither likely nor unlikely to recommend | 1 |
| Unlikely to recommend | 0 |
| Extremely unlikely to recommend | 0 |
| I do not know | 0 |
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".
| score on a pain scale | Standard of Care | Prophylactic Use |
|---|---|---|
| Pain Management at 6-8 Hours | 7.66 (7 to 10) | 6.5 (3 to 9) |
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".
| score on a pain scale | Standard of Care | Prophylactic Use |
|---|---|---|
| Pain Management at 24 Hours | 5 (2 to 8) | 4.8 (1 to 9) |
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".
| score on a nausea scale | Standard of Care | Prophylactic Use |
|---|---|---|
| Nausea Management | 4.33 (1 to 8) | 4 (1 to 7) |
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".
| score on a nausea scale | Standard of Care | Prophylactic Use |
|---|---|---|
| Nausea Management | 3 (1 to 7) | 1.2 (1 to 2) |
Evaluate for a satisfactory pain management regimen for medical abortion based on the need for additional pain medication (Yes vs. No).
| Participants | Standard of Care | Prophylactic Use |
|---|---|---|
| Yes | 3 | 2 |
| No | 0 | 3 |
Evaluate for a satisfactory anti-nausea management regimen for medical abortion based on the additional anti-nausea medication (Yes vs. No).
| Participants | Standard of Care | Prophylactic Use |
|---|---|---|
| Yes | 1 | 0 |
| No | 2 | 5 |
Collected over 24-hour follow-up. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard of Care | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Prophylactic Use | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Categorical(Participants) | Standard of Care | Prophylactic Use | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 5 | 8 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Standard of Care | Prophylactic Use | Total |
|---|---|---|---|
| Mean | 29 (21 to 41) | 29 (22 to 38) | 29 (21 to 41) |
| Sex: Female, Male(Participants) | Standard of Care | Prophylactic Use | Total |
|---|---|---|---|
| Female | 3 | 5 | 8 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Standard of Care | Prophylactic Use | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 0 | 1 | 1 |
| White | 2 | 2 | 4 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Race/Ethnicity, Customized(Participants) | Standard of Care | Prophylactic Use | Total |
|---|---|---|---|
| Hispanic/Latino | 1 | 1 | 2 |
| Non Hispanic/Latino | 1 | 2 | 3 |
| Other- Hispanic/Latino Hispanic/Latino | 0 | 1 | 1 |
| Central or South American | 0 | 1 | 1 |
| Cuban | 1 | 0 | 1 |
| Region of Enrollment(participants) | Standard of Care | Prophylactic Use | Total |
|---|---|---|---|
| United States | 3 | 5 | 8 |
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Hackensack Meridian Health