TerminatedEarly Phase 1

Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days

Stopped: Inability to recruit and staffing changes

United States8 participantsStarted 2023-07-20

Plain-language 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.

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient Satisfaction

Timeframe: At follow up visit, within 2 weeks from the administration of misoprostol

Patient Satisfaction Based on Recommendation of Regimen

Timeframe: At follow up visit, within 2 weeks from the administration of misoprostol

Trial details

NCT IDNCT05819619

SponsorHackensack Meridian Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-01

Results submitted2025-09-17

View on ClinicalTrials.gov More Nausea trials