Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days

NCT ID: NCT05819619

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-20
• Study Completion Date: 2024-04-11

Brief 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.

Conditions

Nausea; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard of care

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

Group Type: ACTIVE_COMPARATOR

Use of ibuprofen and ondansetron at symptom onset post misoprostol administration

Intervention Type: DRUG

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

Prophylactic use

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

Group Type: EXPERIMENTAL

Prophylactic use of ibuprofen and ondansetron post misoprostol administration

Intervention Type: DRUG

Prophylactic use of ibuprofen and ondansetron post misoprostol administration

Interventions

Prophylactic use of ibuprofen and ondansetron post misoprostol administration

Prophylactic use of ibuprofen and ondansetron post misoprostol administration

Intervention Type: DRUG

Use of ibuprofen and ondansetron at symptom onset post misoprostol administration

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hackensack Meridian Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa Figueroa, MD

Role: PRINCIPAL_INVESTIGATOR

Hackensack Meridian Health

Locations

Antonia Oladipo

Hackensack, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro2021-1405

Identifier Type: -

Identifier Source: org_study_id