Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days

Study Overview
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Brief Summary
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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.

Official Title
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Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days

Conditions
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Nausea, Pain

Intervention / Treatment
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* Drug: Prophylactic use of ibuprofen and ondansetron post misoprostol administration
* Drug: Use of ibuprofen and ondansetron at symptom onset post misoprostol administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of care<br>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<br>* Administration of ibuprofen or ondansetron only when experiencing pain or nausea respectively post misoprostol administration.<br>|
| Experimental: Prophylactic use<br>Administration of ibuprofen and ondansetron at the time of misoprostol administration. | Drug: Prophylactic use of ibuprofen and ondansetron post misoprostol administration<br>* Prophylactic use of ibuprofen and ondansetron post misoprostol administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medical abortion, prophylactic use, nausea, pain, patient satisfaction