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Inability to recruit and staffing changes
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | Active Comparator | Administration of ibuprofen or ondansetron only when experiencing pain or nausea respectively post misoprostol administration. |
|
| Prophylactic use | Experimental | Administration of ibuprofen and ondansetron at the time of misoprostol administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prophylactic use of ibuprofen and ondansetron post misoprostol administration | Drug | Prophylactic use of ibuprofen and ondansetron post misoprostol administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | At follow up visit, within 2 weeks from the administration of misoprostol |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | Within 6-8 hours from the administration of misoprostol |
| Pain Management at 24 Hours |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Figueroa, MD | Hackensack Meridian Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antonia Oladipo | Hackensack | New Jersey | 07601 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 20, 2023 |
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| Use of ibuprofen and ondansetron at symptom onset post misoprostol administration | Drug | Administration of ibuprofen or ondansetron only when experiencing pain or nausea respectively post misoprostol administration. |
|
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". |
| 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". | 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". | 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). | 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). | Within 24 hours from the administration of misoprostol |
| FG001 |
| 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | At follow up visit, within 2 weeks from the administration of misoprostol |
|
|
| ||||||||||||||||||||||||||||||||
| 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). | Patients who were part of the active cohort and got the prophylactic administration | Posted | Count of Participants | Participants | At follow up visit, within 2 weeks from the administration of misoprostol |
|
| ||||||||||||||||||||||||||||||||
| 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". | Posted | Mean | Full Range | score on a pain scale | Within 6-8 hours from the administration of misoprostol |
|
| ||||||||||||||||||||||||||||||||
| 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". | Posted | Mean | Full Range | score on a pain scale | Within 24 hours from the administration of misoprostol |
|
| ||||||||||||||||||||||||||||||||
| 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". | Posted | Mean | Full Range | score on a nausea scale | Within 6-8 hours from the administration of misoprostol |
|
| ||||||||||||||||||||||||||||||||
| 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". | Posted | Mean | Full Range | score on a nausea scale | Within 24 hours from the administration of misoprostol |
|
| ||||||||||||||||||||||||||||||||
| 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). | Posted | Count of Participants | Participants | Within 24 hours from the administration of misoprostol |
|
| |||||||||||||||||||||||||||||||||
| 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). | Posted | Count of Participants | Participants | Within 24 hours from the administration of misoprostol |
|
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24-hour follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG001 | 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 | 0 | 5 | 0 | 5 | 0 | 5 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa M. Figueroa, MD, MPH, FACOG | Hackensack Meridian Health | 551-996-8400 | melissa.figueroa@hmhn.org |
| Nov 3, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009325 | Nausea |
| D010146 | Pain |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Non Hispanic/Latino |
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| Other- Hispanic/Latino Hispanic/Latino |
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| Central or South American |
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| Cuban |
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| Neither satisfied nor dissatisfied |
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