Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Nausea
• Intervention / Treatment: 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
• Enrollment (Estimated): 168
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Antonia Oladipo, MD; Phone Number: 5519962765; Email: antonia.oladipo@hmhn.org

Study Locations

• United States
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Recruiting
      • Antonia Oladipo
      • Contact: Antonia Oladipo; Phone Number: 551-996-2765; Email: antonia.oladipo@hmhn.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of care; Administration of ibuprofen or ondansetron only when experiencing pain or nausea respectively post misoprostol administration.	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.
Experimental: Prophylactic use; Administration of ibuprofen and ondansetron at the time of misoprostol administration.	Drug: Prophylactic use of ibuprofen and ondansetron post misoprostol administration; Prophylactic use of ibuprofen and ondansetron post misoprostol administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Determine if prophylactic use of ondansetron and ibuprofen during medical abortion treatment can increase patient satisfaction thereby creating a more favorable outcome. Patient satisfaction will be assessed using a home developed survey. Satisfaction is measured on 5-Likert scale ranging from Very satisfied to Very dissatisfied.	At follow up visit, within 2 weeks from the administration of misoprostol
Patient satisfaction based on recommendation of regimen	Determine if prophylactic use of ondansetron and ibuprofen during medical abortion treatment can increase patient satisfaction based on their likelihood to recommend the regimen. Likelihood to recommend will be assessed using a home developed survey measured on 5-Likert scale ranging from "Extremely likely to recommend" to "Extremely unlikely to recommend" (an additional "I do not know option" will be provided).	At follow up visit, within 2 weeks from the administration of misoprostol

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain management at 6-8 hours	Evaluate for a satisfactory pain management regimen for medical abortion using a numerical pain scale ranging from 1 to 10 with 1 being "no pain" and 10 being "very much pain".	Within 6-8 hours from the administration of misoprostol
Pain management at 24 hours	Evaluate for a satisfactory pain management regimen for medical abortion using a numerical pain scale ranging from 1 to 10 with 1 being "no pain" and 10 being "very much pain".	Within 24 hours from the administration of misoprostol
Nausea Management	Evaluate for a satisfactory anti-nausea management regimen for medical abortion using a numerical nausea scale ranging from 1 to 10 with 1 being "no nausea" and 10 being "very much nausea".	Within 6-8 hours from the administration of misoprostol
Nausea Management	Evaluate for a satisfactory anti-nausea management regimen for medical abortion using a numerical nausea scale ranging from 1 to 10 with 1 being "no nausea" and 10 being "very much nausea".	Within 24 hours from the administration of misoprostol
Need for pain management medication.	Evaluate for a satisfactory pain management regimen for medical abortion based on the need for additional pain medication (Yes vs. No).	Within 24 hours from the administration of misoprostol
Need for anti-nausea medication.	Evaluate for a satisfactory anti-nausea management regimen for medical abortion based on the additional anti-nausea medication (Yes vs. No).	Within 24 hours from the administration of misoprostol

Collaborators and Investigators

• Sponsor: Hackensack Meridian Health
• Investigators: Principal Investigator: Melissa Figueroa, MD, Hackensack Meridian Health

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2023
• Primary Completion (Estimated): July 19, 2025
• Study Completion (Estimated): July 19, 2025

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: pain; nausea; medical abortion; patient satisfaction; prophylactic use
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Serotonin Agents; Serotonin Antagonists; Serotonin 5-HT3 Receptor Antagonists; Reproductive Control Agents; Anti-Ulcer Agents; Antipruritics; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol; Ibuprofen; Ondansetron
• Other Study ID Numbers: Pro2021-1405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No