Overview

Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days

Status:
Not yet recruiting
Trial end date:
2025-03-30
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Hackensack Meridian Health
Treatments:
Ibuprofen
Misoprostol
Ondansetron
Criteria
Inclusion Criteria:

- Healthy

- English speaking

- female volunteers undergoing medical abortion whether for voluntary interruption of
pregnancy or missed abortion

- Gestational age
- 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