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 range18 Years – 50 Years

SexFEMALE

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

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

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