Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days

Early Phase 1TerminatedNCT05819619

Hackensack Meridian Health8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Nausea Pain

Interventions

Prophylactic use of ibuprofen and ondansetron post misoprostol administrationDRUG

Prophylactic use of ibuprofen and ondansetron post misoprostol administration

Use of ibuprofen and ondansetron at symptom onset post misoprostol administrationDRUG

Administration of ibuprofen or ondansetron only when experiencing pain or nausea respectively post misoprostol administration.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Antonia Oladipo

Hackensack, New Jersey, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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".

Data from ClinicalTrials.gov

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