Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days

Pain Clinical Trial

Official title:

Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05819619
• Other study ID #: Pro2021-1405
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 20, 2023
• Est. completion date: July 19, 2025

Study information

• Verified date: January 2024
• Source: Hackensack Meridian Health
• Contact: Antonia Oladipo, MD
• Phone: 5519962765
• Email: antonia.oladipo[@]hmhn.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: July 19, 2025
• Est. primary completion date: July 19, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Pain

Intervention

Drug:
• Prophylactic use of ibuprofen and ondansetron post misoprostol administration
Prophylactic use of ibuprofen and ondansetron post misoprostol administration
• 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.

Locations

Country	Name	City	State
United States	Antonia Oladipo	Hackensack	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Hackensack Meridian Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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