Mifepristone vs Misoprostol for Cervical Preparation

Recruiting at 1 trial location

Overseen By Laura Fletcher, MD, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Phase 1

Sponsor: Montefiore Medical Center

Must not be taking: Anticoagulants

Disqualifiers: Multiple cesareans, Placenta previa, Obstructive fibroid, others

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

Compensation: Varies

Number of Visits: 2

Duration: Up to 2 days

94 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two medications, mifepristone (also known as Mifeprex, Korlym, RU-486, or Mifegyne) and misoprostol (also known as Cytotec), to determine which better prepares the cervix for an abortion procedure between 12 to 16 weeks of pregnancy. Researchers aim to discover if one medication achieves successful cervical dilation more effectively. The trial seeks participants who are English or Spanish-speaking and are seeking an abortion for a single pregnancy within this timeframe. It is not suitable for those with certain medical histories, such as more than two previous C-sections or significant fibroids. As a Phase 1 trial, the research focuses on understanding how the treatment works in people.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using therapeutic anticoagulation.

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

Research has shown that both mifepristone and misoprostol are generally safe for cervical preparation. Studies have found that mifepristone does not cause serious side effects or problems. Other studies report only a few issues with misoprostol, noting a low risk of infection. Serious problems occur at a low rate of about 4% for both drugs. Both treatments are well-tolerated and effective, making them reliable options for cervical preparation. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard of care for cervical preparation, which often involves a combination of mifepristone and misoprostol, this study explores the potential of each drug being used alone. Researchers are excited about mifepristone because it blocks progesterone, which is essential for maintaining pregnancy, and could simplify the procedure if effective on its own. Misoprostol, on the other hand, is unique in its ability to induce uterine contractions and soften the cervix, offering a potential single-drug solution. By investigating these drugs independently, the trial could lead to more streamlined, efficient treatment options for cervical preparation before procedural abortions.

What evidence suggests that this trial's treatments could be effective for cervical preparation?

This trial will compare Mifepristone and Misoprostol for cervical preparation. Research has shown that Mifepristone, which participants in this trial may receive, effectively prepares the cervix. It helps make procedures quicker and easier for doctors, especially during second-trimester abortions. Studies confirm it is a safe and effective way to soften and open the cervix.

Misoprostol, another treatment option in this trial, is also commonly used to prepare the cervix and start labor. It works well, though it might not open the cervix as much as some other methods. Even so, Misoprostol remains a dependable option for getting the cervix ready before procedures. ^{1 3 4 6 7}

Who Is on the Research Team?

Antoinette Danvers, MD, MSCR, MBA

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals seeking procedural abortions at 12 to 16 weeks and who can receive hospital-based care. Specific eligibility criteria are not provided, but typically participants would need to be in good health with no contraindications for the medications being tested.

Inclusion Criteria

Seeking induced abortion of a singleton pregnancy

I am able to understand and agree to the study's requirements.

I am between 12 and 16 weeks pregnant, based on the surgical date.

Exclusion Criteria

I have had more than one surgery to remove part of my cervix.

I have a cerclage in place.

I am currently using blood thinners for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either Mifepristone or Misoprostol for cervical preparation prior to procedural abortion

Up to 2 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure, including assessment of intraoperative complications and patient satisfaction

Up to 2 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Mifepristone
• Misoprostol

Trial Overview

The study is testing whether mifepristone alone or misoprostol alone is more effective for cervical preparation before an abortion procedure. Participants will be randomly assigned to one of these two medication groups to compare success rates of cervical dilation.

How Is the Trial Designed?

Group I: Misoprostol Experimental Treatment 1 Intervention

Patients will be randomized to Misoprostol-alone in a 1:1 ratio prior to procedural abortions. A paracervical block of 20cc 1% lidocaine, with or without vasopressin, will be administered in accordance with standard practices.

Group II: Mifepristone Experimental Treatment 1 Intervention

Patients will be randomized to Mifepristone-alone in a 1:1 manner prior to procedural abortions. A paracervical block of 20 cubic centimeters (cc) 1% lidocaine, with or without vasopressin, will be administered in accordance with standard practices.

Mifepristone is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Mifeprex for:

• Abortion
• Cushing's Syndrome

Approved in European Union as Mifegyne for:

• Abortion
• Cushing's Syndrome

Approved in Canada as Mifeprex for:

• Abortion
• Cushing's Syndrome

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Published Research Related to This Trial

In a study of 61 patients, intravaginal misoprostol was found to be significantly more effective than intracervical dinoprostone for cervical ripening, with 56% of women in the misoprostol group achieving ripening within 12 hours compared to only 17% in the dinoprostone group.

Misoprostol required fewer doses and resulted in a shorter time from induction to delivery, with only 50% of patients needing oxytocin for labor augmentation compared to 90% in the dinoprostone group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between vaginal misoprostol and cervical dinoprostone for cervical ripening and labor induction. Neiger, R., Greaves, PC.[2013]

RU 486 (Mifepristone) is a significant advancement as the first effective antiprogestogen, primarily used for first trimester abortions, especially when combined with prostaglandins.

The drug has also shown potential in cervical ripening and labor induction, but further research is necessary to ensure its safety for use in viable pregnancies during the third trimester.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The antiprogesterone steroid, RU 486 (mifepristone). Permezel, M.[2019]

In a study of 198 women undergoing elective surgical abortions between 12 and 14 weeks of gestation, the combination of mifepristone and misoprostol significantly reduced intraoperative bleeding compared to either drug alone, with an average blood loss of 222 mL in the combination group versus 329 mL for misoprostol and 276 mL for mifepristone.

The combination treatment also led to a shorter operative duration, averaging 5 minutes compared to 7 minutes for both the misoprostol and mifepristone groups, indicating improved efficiency in the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mifepristone and misoprostol for cervical ripening in surgical abortion between 12 and 14 weeks of gestation: a randomized controlled trial. Ohannessian, A., Baumstarck, K., Maruani, J., et al.[2017]

RU486 (mifepristone) combined with a prostaglandin analogue has a high efficacy rate of 95.3% for early pregnancy termination, with a slight increase to 96.9% when followed by misoprostol, indicating it is a reliable medical alternative to surgical procedures.

While the treatment is generally safe, there are potential side effects and serious adverse events, including a fatality, which necessitate careful medical monitoring for several hours after administration of the prostaglandin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RU486: the French experience. Ulmann, A., Silvestre, L.[2019]

In a study of 100 women seeking abortion between 14 to 19 weeks of gestation, the addition of 200 mg of mifepristone to vaginal misoprostol did not significantly improve cervical dilation compared to misoprostol alone, with mean dilations of 11.7 mm and 10.9 mm respectively.

All procedures were completed safely without complications, indicating that both treatment options are safe, but the combination of mifepristone and misoprostol does not enhance cervical preparation for dilation and evacuation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial evaluating same-day mifepristone and misoprostol compared to misoprostol alone for cervical preparation prior to second-trimester surgical abortion. Casey, FE., Ye, PP., Perritt, JD., et al.[2018]

In a study of 62 patients undergoing medical termination of early pregnancy with mifepristone (RU 486) and a prostaglandin analogue, the method achieved a high success rate of 97%.

The procedure had rare side effects, although about half of the patients required strong analgesics, indicating that while effective, pain management is an important consideration during the process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Reintroduction of medical abortion in Denmark]. Olsen, CD., Wittendorff, HE., Jørgensen, JJ.[2014]

Mifepristone is highly effective as an abortifacient, with a success rate of 98% when used in a regimen of a single 600-mg oral dose followed by misoprostol, particularly for women less than 8 weeks pregnant.

While the most common side effect is painful contractions experienced by up to 93% of women, overall patient satisfaction with medical abortion using mifepristone is high, indicating its acceptability as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mifepristone (RU 486): current knowledge and future prospects. Goldberg, JR., Plescia, MG., Anastasio, GD.[2019]

In a study of 40 women undergoing early pregnancy medical abortion, Mifepristone significantly reduced the need for additional cervical dilation during vacuum aspiration, with 35% of treated patients requiring no further dilation compared to 100% in the placebo group.

Mifepristone also resulted in greater initial cervical dilation and reduced perioperative blood loss, demonstrating its safety and efficacy as a cervical priming agent without serious complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mifepristone (RU 486) for cervical priming prior to surgically induced abortion in the late first trimester. Urquhart, DR., Templeton, AA.[2019]

In a pilot study of 25 women, using Dilapan-S as a cervical preparation before misoprostol resulted in 17 successful abortions within a median time of 6 hours, indicating effective use of this method.

Most participants reported only mild discomfort during the procedure, with 14 out of 25 rating their experience as excellent, suggesting that this combination may reduce pain associated with early medical abortion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hygroscopic dilator (Dilapan-S) and misoprostol combination for the early first-trimester termination of pregnancy: a pilot study. Samuel, MI., Parsons, JH.[2016]

Misoprostol is an effective and cost-efficient medication for medical termination of pregnancies and cervical priming, showing promise in both first and second trimester procedures.

Despite its effectiveness, misoprostol has not been officially approved by the manufacturer for use as an abortifacient, similar to the situation with mifepristone, which limits its formal endorsement for this purpose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of misoprostol in first and second trimester abortion: a review. Scheepers, HC., van Erp, EJ., van den Bergh, AS.[2019]

In a study involving 35 patients, mifepristone (RU486) was safely administered for therapeutic interruption of pregnancy, with no recorded toxicity or maternal morbidity.

Mifepristone effectively modified cervical consistency, improving cervical calibration regardless of the dose used (150 mg or 450 mg), which may facilitate the labor process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mifepristone (RU486) and therapeutic late pregnancy termination: a double-blind study of two different doses. Frydman, R., Fernandez, H., Pons, JC., et al.[2019]

In a study of women undergoing second-trimester termination of pregnancy, mifepristone combined with misoprostol was found to be as effective as misoprostol alone (with or without laminaria) for cervical preparation, showing no significant difference in the difficulty of cervical dilation.

The use of mifepristone did not lead to an increase in complications during the procedure, indicating it is a safe option for cervical priming in both multiparous and primiparous women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of mifepristone for cervical priming for second-trimester surgical termination of pregnancy. Searle, L., Tait, J., Langdana, F., et al.[2016]

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Mifepristone - StatPearls - NCBI Bookshelf

Apart from its predominant use in medically induced abortions, mifepristone proves valuable in addressing Cushing syndrome and uterine leiomyomas.