Ibuprofen + Ondansetron for Medical Abortion Side Effects

Recruiting in Palo Alto (17 mi)

Overseen by Melissa Figueroa, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Hackensack Meridian Health

Must not be taking: Analgesics

Disqualifiers: Cardiac conditions, malignancy, organ damage, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you do not take medications that interact with ondansetron or ibuprofen, and you cannot be on chronic pain medications. If you're on such medications, you may need to stop them to participate.

What data supports the effectiveness of the drug combination of Ibuprofen and Ondansetron for reducing side effects of medical abortion?

Research shows that ibuprofen is effective in reducing pain, as seen in studies where it decreased pain in postoperative patients. This suggests it may help manage pain-related side effects in medical abortion. ^{1 2 3 4 5}

Is the combination of ibuprofen and ondansetron generally safe for humans?

Ibuprofen is a widely used over-the-counter medication with a favorable safety profile, though it can cause gastrointestinal, renal, and hepatic side effects depending on the dose and patient population. Ondansetron is commonly used to prevent nausea and vomiting and is generally considered safe, but specific safety data on the combination of ibuprofen and ondansetron for medical abortion side effects is not provided in the available research. ^{1 6 7 8 9}

How does the drug combination of ibuprofen and ondansetron differ from other treatments for medical abortion side effects?

The combination of ibuprofen and ondansetron is unique because it targets both pain and nausea, which are common side effects of medical abortion. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that helps reduce pain, while ondansetron is used to prevent nausea and vomiting, offering a more comprehensive approach to managing these side effects compared to treatments that address only one symptom. ^{8 9 10 11 12}

Research Team

Melissa Figueroa, MD

Principal Investigator

Hackensack Meridian Health

Eligibility Criteria

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.

Inclusion Criteria

I am willing to do follow-ups over the phone or in person.

Healthy

Gestational age </= 70 days confirmed via ultrasound

Exclusion Criteria

I had a surgical procedure after a medical abortion didn't work.

I have chronic conditions like heart issues or organ damage.

I am taking medications that interact with ondansetron or ibuprofen.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive prophylactic use of ondansetron and ibuprofen at the time of misoprostol administration

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

Treatment Details

Interventions

• Ibuprofen (Nonsteroidal Anti-inflammatory Drug (NSAID))
• Ondansetron (Anti-Emetic)

Trial Overview 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.

Participant Groups

Group I: Prophylactic use Experimental Treatment 1 Intervention

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

Group II: Standard of care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Hackensack Meridian Health

Lead Sponsor

Trials

141

Recruited

42,900+

Dr. Gregory J. Rokosz

Hackensack Meridian Health

Chief Medical Officer since 2023

DO from New York College of Osteopathic Medicine, JD from Seton Hall University School of Law

Robert C. Garrett

Hackensack Meridian Health

Chief Executive Officer since 2016

Bachelor's degree in Health Administration from Washington University in St. Louis

Findings from Research

Over a 10-year period, a total of 29,656,286 units of various ibuprofen formulations were sold in Poland, with only 5 spontaneous reports of adverse effects, indicating that ibuprofen is a very safe medication with rare side effects.

The study suggests that while ibuprofen is generally safe, the current monitoring system for adverse effects in Poland is insufficient and requires enhancements to better detect potential issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of oral ibuprofen--analysis of data from the spontaneous reporting system in Poland. Kuchari, E., Han, S., Karłowicz-Bodalska, K., et al.[2022]

Ibuprofen is effective in managing pain and inflammation, but its use requires careful consideration in patients with certain conditions, such as renal disease and bleeding disorders, due to its effects on prostaglandins.

The drug can be safely used in various patient populations, including the elderly and those with specific diseases, but clinicians should be cautious when prescribing it alongside other medications like aspirin or warfarin, as interactions may occur.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of ibuprofen in unusual circumstances. Furst, DE.[2019]

In a study of 115 patients undergoing lower abdominal gynecological surgery, preoperative administration of sustained-release ibuprofen significantly reduced pain at rest compared to placebo, enhancing patient satisfaction with pain relief and sleep quality.

While morphine consumption was slightly lower in the ibuprofen group, the difference was not statistically significant, indicating that ibuprofen can effectively improve pain management without increasing opioid side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained-release ibuprofen as an adjunct to morphine patient-controlled analgesia. Plummer, JL., Owen, H., Ilsley, AH., et al.[2019]

In a study of 25 patients undergoing alcohol and opioid detoxification with low platelet counts, over 70% had active orders for ibuprofen, and 50% actually received it, raising safety concerns.

Patients with platelet counts below 100,000/µL were more likely to receive ibuprofen and at higher doses, suggesting a need for careful monitoring and reconsideration of ibuprofen use in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Incidence of Ibuprofen Administration in Alcohol and Opioid Detoxification Patients With Concomitant Thrombocytopenia. Muhammad, S., Tomko, JR., Wilson, LM.[2019]

In a phase 4 study involving 4042 patients with osteoarthritis, indoprofen was generally well-tolerated, with adverse events occurring in 22% of patients, and less than 5% needing to stop treatment due to drug-related issues.

The safety profile of indoprofen showed that gastrointestinal issues were the most common side effects, similar to other NSAIDs, and tolerability was better with parenteral administration compared to oral, especially at higher doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse reactions to indoprofen: a survey based on a total of 6764 patients. Bruni, G., Lavezzari, M., Perbellini, A., et al.[2017]

Ibuprofen has a favorable safety profile compared to other NSAIDs, with a lower risk of cardiovascular adverse effects, although it can still cause gastrointestinal, renal, and hepatic issues depending on dosage and patient factors.

Recent studies suggest that ibuprofen may have complex interactions with infections, potentially increasing risk in some cases while offering benefits in others, such as in cystic fibrosis, and it may also have emerging roles as an endocrine disruptor and in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ibuprofen Safety at the Golden Anniversary: Are all NSAIDs the Same? A Narrative Review. Varrassi, G., Pergolizzi, JV., Dowling, P., et al.[2020]

In a study of the first 100 patients undergoing early medical abortion at Herlev University Hospital, the regimen using 600 mg mifepristone followed by gemeprost showed a high effectiveness rate of 96%.

Most women experienced mild side effects, with 91% managing pain without opioids, and 80% expressing a willingness to choose the same method for future abortions, indicating overall satisfaction with the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The first 100 early medical abortions]. Lidegaard, O., Larsen, JF., Blaabjerg, J., et al.[2015]

In a study of 61 women undergoing medical abortion, pre-emptive administration of ibuprofen significantly reduced the need for additional pain relief compared to a placebo, indicating its efficacy in managing pain during the procedure.

The use of ibuprofen did not interfere with the effectiveness of misoprostol or increase the failure rate of the abortion, suggesting it is a safe option for pain management in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-emptive effect of ibuprofen versus placebo on pain relief and success rates of medical abortion: a double-blind, randomized, controlled study. Avraham, S., Gat, I., Duvdevani, NR., et al.[2015]

In a randomized trial involving 999 women, vaginal misoprostol was found to be more effective than gemeprost for medical abortion, achieving a complete abortion rate of 98.7% compared to 96.2% for gemeprost.

Both medications had similar side effects, but misoprostol resulted in fewer ongoing pregnancies and a lower need for surgical intervention, making it the preferred choice for inducing abortion in early pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double-blind randomized trial of mifepristone in combination with vaginal gemeprost or misoprostol for induction of abortion up to 63 days gestation. Bartley, J., Brown, A., Elton, R., et al.[2019]

In a study involving 896 women seeking medical abortion, both 200 mg and 600 mg doses of mifepristone showed similar effectiveness, with complete abortion rates of 92.4% and 91.7%, respectively.

The lower 200 mg dose of mifepristone is just as effective as the higher dose, while also resulting in fewer side effects, particularly less nausea reported compared to the 600 mg group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical abortion at 57 to 63 days' gestation with a lower dose of mifepristone and gemeprost. A randomized controlled trial. [2014]

In a study involving 1182 women seeking abortion, all three doses of mifepristone (200 mg, 400 mg, and 600 mg) showed similar efficacy, with over 94% achieving a complete abortion, indicating that a lower dose (200 mg) is just as effective as the higher doses.

The side effects and complications were comparable across all doses, suggesting that the 200 mg dose could be a safer and more cost-effective option for early pregnancy termination without compromising effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Termination of pregnancy with reduced doses of mifepristone. World Health Organisation Task Force on Post-ovulatory Methods of Fertility Regulation. [2019]

References

1. Poland pubmed.ncbi.nlm.nih.gov

Safety of oral ibuprofen--analysis of data from the spontaneous reporting system in Poland. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Use of ibuprofen in unusual circumstances. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Sustained-release ibuprofen as an adjunct to morphine patient-controlled analgesia. [2019]

4. Poland pubmed.ncbi.nlm.nih.gov

[Current opinions on embryotoxic and teratogenic effects of ibuprofen]. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the Incidence of Ibuprofen Administration in Alcohol and Opioid Detoxification Patients With Concomitant Thrombocytopenia. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Adverse reactions to indoprofen: a survey based on a total of 6764 patients. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Ibuprofen Safety at the Golden Anniversary: Are all NSAIDs the Same? A Narrative Review. [2020]

8. Denmark pubmed.ncbi.nlm.nih.gov

[The first 100 early medical abortions]. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Pre-emptive effect of ibuprofen versus placebo on pain relief and success rates of medical abortion: a double-blind, randomized, controlled study. [2015]

10. England pubmed.ncbi.nlm.nih.gov

Double-blind randomized trial of mifepristone in combination with vaginal gemeprost or misoprostol for induction of abortion up to 63 days gestation. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Medical abortion at 57 to 63 days' gestation with a lower dose of mifepristone and gemeprost. A randomized controlled trial. [2014]

12. England pubmed.ncbi.nlm.nih.gov

Termination of pregnancy with reduced doses of mifepristone. World Health Organisation Task Force on Post-ovulatory Methods of Fertility Regulation. [2019]