Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days

Early Phase 1

Recruiting

• Conditions: Nausea; Pain
• Interventions: Drug: Prophylactic use of ibuprofen and ondansetron post misoprostol administration; Drug: Use of ibuprofen and ondansetron at symptom onset post misoprostol administration

• Registration Number: NCT05819619
• Lead Sponsor: Hackensack Meridian Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-04-18
• Study First Posted: 2023-04-19
• Study Start: 2023-07-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-07-19
• Study Completion: 2025-07-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 168

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prophylactic use	Prophylactic use of ibuprofen and ondansetron post misoprostol administration	Administration of ibuprofen and ondansetron at the time of misoprostol administration.
Standard of care	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.

Primary Outcome Measures

Name	Time	Method
Patient satisfaction	At follow up visit, within 2 weeks from the administration of misoprostol	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.
Patient satisfaction based on recommendation of regimen	At follow up visit, within 2 weeks from the administration of misoprostol	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).

Secondary Outcome Measures

Name	Time	Method
Pain management at 24 hours	Within 24 hours from the administration of misoprostol	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".
Need for pain management medication.	Within 24 hours from the administration of misoprostol	Evaluate for a satisfactory pain management regimen for medical abortion based on the need for additional pain medication (Yes vs. No).
Need for anti-nausea medication.	Within 24 hours from the administration of misoprostol	Evaluate for a satisfactory anti-nausea management regimen for medical abortion based on the additional anti-nausea medication (Yes vs. No).
Pain management at 6-8 hours	Within 6-8 hours from the administration of misoprostol	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".
Nausea Management	Within 24 hours from the administration of misoprostol	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".

Trial Locations

Locations (1)

Antonia Oladipo; 🇺🇸 Hackensack, New Jersey, United States