Ibuprofen + Ondansetron for Medical Abortion Side Effects

Overseen By Antonia Oladipo, MD

Age: 18 - 65

Sex: Female

Trial Phase: Phase < 1

Sponsor: Hackensack Meridian Health

Must not be taking: Analgesics

Disqualifiers: Cardiac conditions, malignancy, organ damage, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how combining ibuprofen (a common pain reliever) and ondansetron (an anti-nausea medication) might reduce side effects of medical abortion, such as pain and nausea, and improve patient experience. The study compares two approaches: taking these medications only when side effects begin or taking them when the abortion medication (misoprostol) is administered. Healthy women who speak English and are undergoing a medical abortion with a pregnancy under 70 days may qualify. Participants must also have a way to track time and be willing to complete a follow-up by phone or in person. As an Early Phase 1 trial, this research aims to understand how these medications work together in people, offering participants a chance to contribute to foundational medical knowledge.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ibuprofen and ondansetron are well-known medications. Ibuprofen often relieves pain, while ondansetron helps prevent nausea, both common side effects of medical abortions.

Ibuprofen is widely used and generally considered safe for managing pain, including after medical procedures. Ondansetron is also commonly used to prevent nausea and vomiting. Both drugs have been used separately for many years and are known to be safe.

Current information does not indicate any new or serious safety concerns when using them together. The idea is that using both might better manage the side effects of medical abortion, like pain and nausea, and improve overall comfort.

This trial is in its early stages, focusing on the safety of using both drugs together in this new way. While these drugs are usually well-tolerated, participating in the trial will help gather more data on their safety as a combination for this specific use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores a new approach to managing side effects of medical abortion. Unlike the standard treatment, which involves taking ibuprofen or ondansetron only when pain or nausea occurs, this trial tests the proactive use of both medications at the same time as the abortion medication, misoprostol. This approach could potentially prevent discomfort before it starts, offering a more comfortable experience. If successful, this strategy might streamline the process, reducing the need for reactive pain and nausea management.

What evidence suggests that this trial's treatments could be effective for reducing medical abortion side effects?

Research shows that ibuprofen helps manage pain during medical abortions and works better than paracetamol, especially in the first 14 weeks of pregnancy. Ondansetron often reduces nausea, a common side effect of misoprostol, a medication used in medical abortions. In this trial, one group will receive ibuprofen and ondansetron only when experiencing pain or nausea, while another group will receive both medications prophylactically at the time of misoprostol administration. These medications together aim to reduce discomfort by addressing both pain and nausea. While strong evidence supports ibuprofen's effectiveness, the combination with ondansetron is still under study to understand its full benefits in this situation. ^{1 2 6 7 8}

Who Is on the Research Team?

Melissa Figueroa, MD

Principal Investigator

Hackensack Meridian Health

Are You a Good Fit for This Trial?

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

Healthy

Gestational age </= 70 days confirmed via ultrasound

Access to a time keeping device

Exclusion Criteria

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

Known intrauterine infection

Known allergy to ondansetron or ibuprofen

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Ibuprofen
• Ondansetron

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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 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 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]

Ibuprofen is effective for pain relief, fever reduction, and inflammation, showing good tolerability in low doses for both adults and children over 6 months, which supports its availability as an over-the-counter medication.

While ibuprofen has not been shown to cause major birth defects in animal studies, there are concerns about its use during pregnancy, including potential risks like implantation issues and specific congenital malformations such as gastroschisis, which have been observed in large human studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current opinions on embryotoxic and teratogenic effects of ibuprofen]. Burdan, F., Bełzek, A.[2013]

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]

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 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]

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]

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]

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What can you expect after a medical abortion? Vaginal bleeding and cramping are the biggest side effects. While the heaviest bleeding typically occurs ...