Overview
Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2025-03-30
2025-03-30
Target enrollment:
0
0
Participant gender:
Female
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 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Hackensack Meridian HealthTreatments:
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 = 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