Trial Outcomes & Findings for Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days (NCT NCT05819619)
NCT ID: NCT05819619
Last Updated: 2025-11-17
Results Overview
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.
Recruitment status
TERMINATED
Study phase
EARLY_PHASE1
Target enrollment
8 participants
Primary outcome timeframe
At follow up visit, within 2 weeks from the administration of misoprostol
Results posted on
2025-11-17
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
|
Overall Study
COMPLETED
|
0
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days
Baseline characteristics by cohort
| Measure |
Standard of Care
n=3 Participants
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.
|
Prophylactic Use
n=5 Participants
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
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=39 Participants
|
5 Participants
n=29 Participants
|
8 Participants
n=60 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Age, Continuous
|
29 years
n=39 Participants
|
29 years
n=29 Participants
|
29 years
n=60 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=39 Participants
|
5 Participants
n=29 Participants
|
8 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=39 Participants
|
2 Participants
n=29 Participants
|
4 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
2 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
1 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
2 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Non Hispanic/Latino
|
1 Participants
n=39 Participants
|
2 Participants
n=29 Participants
|
3 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Other- Hispanic/Latino Hispanic/Latino
|
0 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
1 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Central or South American
|
0 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
1 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Cuban
|
1 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
1 Participants
n=60 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=39 Participants
|
5 participants
n=29 Participants
|
8 participants
n=60 Participants
|
PRIMARY outcome
Timeframe: At follow up visit, within 2 weeks from the administration of misoprostolDetermine 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.
Outcome measures
| Measure |
Standard of Care
n=3 Participants
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.
|
Prophylactic Use
n=4 Participants
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
|
|---|---|---|
|
Patient Satisfaction
Neither satisfied nor dissatisfied
|
0 Participants
|
1 Participants
|
|
Patient Satisfaction
Very satisfied
|
1 Participants
|
1 Participants
|
|
Patient Satisfaction
Fairly satisfied
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: At follow up visit, within 2 weeks from the administration of misoprostolPopulation: Patients who were part of the active cohort and got the prophylactic administration
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).
Outcome measures
| Measure |
Standard of Care
n=4 Participants
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.
|
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
|
|---|---|---|
|
Patient Satisfaction Based on Recommendation of Regimen
Extremely likely to recommend
|
1 Participants
|
—
|
|
Patient Satisfaction Based on Recommendation of Regimen
Likely to recommend
|
2 Participants
|
—
|
|
Patient Satisfaction Based on Recommendation of Regimen
Neither likely nor unlikely to recommend
|
1 Participants
|
—
|
|
Patient Satisfaction Based on Recommendation of Regimen
Unlikely to recommend
|
0 Participants
|
—
|
|
Patient Satisfaction Based on Recommendation of Regimen
Extremely unlikely to recommend
|
0 Participants
|
—
|
|
Patient Satisfaction Based on Recommendation of Regimen
I do not know
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Within 6-8 hours from the administration of misoprostolEvaluate 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".
Outcome measures
| Measure |
Standard of Care
n=3 Participants
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.
|
Prophylactic Use
n=4 Participants
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
|
|---|---|---|
|
Pain Management at 6-8 Hours
|
7.66 score on a pain scale
Interval 7.0 to 10.0
|
6.5 score on a pain scale
Interval 3.0 to 9.0
|
SECONDARY outcome
Timeframe: Within 24 hours from the administration of misoprostolEvaluate 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".
Outcome measures
| Measure |
Standard of Care
n=3 Participants
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.
|
Prophylactic Use
n=4 Participants
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
|
|---|---|---|
|
Pain Management at 24 Hours
|
5 score on a pain scale
Interval 2.0 to 8.0
|
4.8 score on a pain scale
Interval 1.0 to 9.0
|
SECONDARY outcome
Timeframe: Within 6-8 hours from the administration of misoprostolEvaluate 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".
Outcome measures
| Measure |
Standard of Care
n=3 Participants
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.
|
Prophylactic Use
n=4 Participants
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
|
|---|---|---|
|
Nausea Management
|
4.33 score on a nausea scale
Interval 1.0 to 8.0
|
4 score on a nausea scale
Interval 1.0 to 7.0
|
SECONDARY outcome
Timeframe: Within 24 hours from the administration of misoprostolEvaluate 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".
Outcome measures
| Measure |
Standard of Care
n=3 Participants
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.
|
Prophylactic Use
n=5 Participants
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
|
|---|---|---|
|
Nausea Management
|
3 score on a nausea scale
Interval 1.0 to 7.0
|
1.2 score on a nausea scale
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: Within 24 hours from the administration of misoprostolEvaluate for a satisfactory pain management regimen for medical abortion based on the need for additional pain medication (Yes vs. No).
Outcome measures
| Measure |
Standard of Care
n=3 Participants
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.
|
Prophylactic Use
n=5 Participants
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
|
|---|---|---|
|
Need for Pain Management Medication.
Yes
|
3 Participants
|
2 Participants
|
|
Need for Pain Management Medication.
No
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Within 24 hours from the administration of misoprostolEvaluate for a satisfactory anti-nausea management regimen for medical abortion based on the additional anti-nausea medication (Yes vs. No).
Outcome measures
| Measure |
Standard of Care
n=3 Participants
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.
|
Prophylactic Use
n=5 Participants
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
|
|---|---|---|
|
Need for Anti-nausea Medication.
Yes
|
1 Participants
|
0 Participants
|
|
Need for Anti-nausea Medication.
No
|
2 Participants
|
5 Participants
|
Adverse Events
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Prophylactic Use
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Melissa M. Figueroa, MD, MPH, FACOG
Hackensack Meridian Health
Phone: 551-996-8400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place