Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days

Hackensack Meridian Health

Status and phase: Terminated; Early Phase 1

Conditions: Nausea; Pain

Treatments: Drug: Use of ibuprofen and ondansetron at symptom onset post misoprostol administration; Drug: Prophylactic use of ibuprofen and ondansetron post misoprostol administration

Study type: Interventional

Funder types: Other

Identifiers

NCT05819619

Pro2021-1405

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Standard of care

Active Comparator group

Description:

Administration of ibuprofen or ondansetron only when experiencing pain or nausea respectively post misoprostol administration.

Treatment:

Drug: Use of ibuprofen and ondansetron at symptom onset post misoprostol administration

Prophylactic use

Experimental group

Description:

Administration of ibuprofen and ondansetron at the time of misoprostol administration.

Treatment:

Drug: Prophylactic use of ibuprofen and ondansetron post misoprostol administration