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Ibuprofen + Ondansetron for Medical Abortion Side Effects

Q: Is the age threshold for participating in this research above 35 years old?

This clinical trial limits enrollment to those aged between 18 and 50. However, there are 82 trials for minors and 321 studies for elderly individuals over 65 years of age.

Q: How many participants are being monitored in this research endeavor?

That is correct. Data on clinicaltrials.gov reveals that the trial, which was initially unveiled on July 20th 2023, is still in search of individuals to participate. One medical centre needs 168 patients for this study.

Q: Is the enrollment period still ongoing for this investigation?

Clinicaltrials.gov confirms that the recruitment of participants for this trial is ongoing, initiated on July 20th 2022 and most recently edited a day later.

Q: To whom is this trial open for enrollment?

This research seeks 168 participants aged 18-50 that are experiencing nausea. To qualify, possible candidates must meet the following requirements: Healthy, English-speaking female volunteers having a medical abortion (voluntary or missed), gestational age of 70 days or less confirmed by ultrasound scan, access to a time keeping device and willingness to complete follow up calls/interviews in clinic.

Q: What are the intended outcomes of this research endeavor?

The primary goal of this clinical experiment, measured at a follow-up visit within two weeks of misoprostol administration, is to evaluate patient satisfaction with the prescribed regimen. Secondary objectives include gauging <a href="https://www.withpower.com/clinical-trials/pain-management">pain management</a> using a numerical scale ranging from 1 to 10 and quantifying nausea levels on the same metrics; additionally, researchers are assessing whether or not additional anti-nausea drugs were necessary.

Phase < 1

Recruiting

Led By Melissa Figueroa, MD

Research Sponsored by Hackensack Meridian Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 6-8 hours from the administration of misoprostol

Awards & highlights

Study Summary

This trial will study if drugs can reduce side effects and improve satisfaction with medical abortion.

Who is the study for?

This trial is for healthy, English-speaking women who are up to 70 days pregnant as confirmed by ultrasound. They must have access to a timekeeping device and be willing to do a follow-up via phone or in-clinic. It's not for those with chronic health issues like heart disease, cancer, organ damage, or those on drugs that interact with ibuprofen or ondansetron.Check my eligibility

What is being tested?

The study is testing if taking painkillers (ibuprofen) and anti-nausea medication (ondansetron) right after using misoprostol can reduce side effects of medical abortion and improve patient satisfaction. Participants will either get these meds before symptoms start or when they begin feeling sick.See study design

What are the potential side effects?

Possible side effects from the medications include stomach upset, bleeding problems for ibuprofen; headache, dizziness, constipation for ondansetron. These drugs might also cause allergic reactions in some people.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 6-8 hours from the administration of misoprostol

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 6-8 hours from the administration of misoprostol

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 6-8 hours from the administration of misoprostol for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient satisfaction

Patient satisfaction based on recommendation of regimen

Secondary outcome measures

Nausea Management

Need for anti-nausea medication.

Need for pain management medication.

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Prophylactic useExperimental Treatment1 Intervention

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

Group II: Standard of careActive Control1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hackensack Meridian HealthLead Sponsor

131 Previous Clinical Trials

28,076 Total Patients Enrolled

1 Trials studying Nausea

30 Patients Enrolled for Nausea

Melissa Figueroa, MDPrincipal InvestigatorHackensack Meridian Health

Media Library

Prophylactic use Clinical Trial Eligibility Overview. Trial Name: NCT05819619 — Phase < 1

Nausea Research Study Groups: Standard of care, Prophylactic use

Nausea Clinical Trial 2023: Prophylactic use Highlights & Side Effects. Trial Name: NCT05819619 — Phase < 1

Prophylactic use 2023 Treatment Timeline for Medical Study. Trial Name: NCT05819619 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age threshold for participating in this research above 35 years old?

"This clinical trial limits enrollment to those aged between 18 and 50. However, there are 82 trials for minors and 321 studies for elderly individuals over 65 years of age."

Answered by AI

How many participants are being monitored in this research endeavor?

"That is correct. Data on clinicaltrials.gov reveals that the trial, which was initially unveiled on July 20th 2023, is still in search of individuals to participate. One medical centre needs 168 patients for this study."

Answered by AI

Is the enrollment period still ongoing for this investigation?

"Clinicaltrials.gov confirms that the recruitment of participants for this trial is ongoing, initiated on July 20th 2022 and most recently edited a day later."

Answered by AI

To whom is this trial open for enrollment?

"This research seeks 168 participants aged 18-50 that are experiencing nausea. To qualify, possible candidates must meet the following requirements: Healthy, English-speaking female volunteers having a medical abortion (voluntary or missed), gestational age of 70 days or less confirmed by ultrasound scan, access to a time keeping device and willingness to complete follow up calls/interviews in clinic."

Answered by AI

What are the intended outcomes of this research endeavor?

"The primary goal of this clinical experiment, measured at a follow-up visit within two weeks of misoprostol administration, is to evaluate patient satisfaction with the prescribed regimen. Secondary objectives include gauging pain management using a numerical scale ranging from 1 to 10 and quantifying nausea levels on the same metrics; additionally, researchers are assessing whether or not additional anti-nausea drugs were necessary."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days

2023. "Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05819619.