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Ibuprofen + Ondansetron for Medical Abortion Side Effects

Phase < 1
Recruiting
Led By Melissa Figueroa, MD
Research Sponsored by Hackensack Meridian Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 6-8 hours from the administration of misoprostol
Awards & highlights
No Placebo-Only Group

Summary

This trial will study if drugs can reduce side effects and improve satisfaction with medical abortion.

Who is the study for?
This trial is for healthy, English-speaking women who are up to 70 days pregnant as confirmed by ultrasound. They must have access to a timekeeping device and be willing to do a follow-up via phone or in-clinic. It's not for those with chronic health issues like heart disease, cancer, organ damage, or those on drugs that interact with ibuprofen or ondansetron.
What is being tested?
The study is testing if taking painkillers (ibuprofen) and anti-nausea medication (ondansetron) right after using misoprostol can reduce side effects of medical abortion and improve patient satisfaction. Participants will either get these meds before symptoms start or when they begin feeling sick.
What are the potential side effects?
Possible side effects from the medications include stomach upset, bleeding problems for ibuprofen; headache, dizziness, constipation for ondansetron. These drugs might also cause allergic reactions in some people.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 6-8 hours from the administration of misoprostol
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 6-8 hours from the administration of misoprostol for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Patient satisfaction
Patient satisfaction based on recommendation of regimen
Secondary study objectives
Nausea Management
Need for anti-nausea medication.
Need for pain management medication.
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Prophylactic useExperimental Treatment1 Intervention
Administration of ibuprofen and ondansetron at the time of misoprostol administration.
Group II: Standard of careActive Control1 Intervention
Administration of ibuprofen or ondansetron only when experiencing pain or nausea respectively post misoprostol administration.

Find a Location

Who is running the clinical trial?

Hackensack Meridian HealthLead Sponsor
135 Previous Clinical Trials
30,154 Total Patients Enrolled
Melissa Figueroa, MDPrincipal InvestigatorHackensack Meridian Health

Media Library

Prophylactic use Clinical Trial Eligibility Overview. Trial Name: NCT05819619 — Phase < 1
Nausea and Vomiting Research Study Groups: Standard of care, Prophylactic use
Nausea and Vomiting Clinical Trial 2023: Prophylactic use Highlights & Side Effects. Trial Name: NCT05819619 — Phase < 1
Prophylactic use 2023 Treatment Timeline for Medical Study. Trial Name: NCT05819619 — Phase < 1
~44 spots leftby Jul 2025
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