Mifepristone vs Misoprostol for Cervical Preparation

Overseen By Laura Fletcher, MD, MPH

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Montefiore Medical Center

Must not be taking: Anticoagulants

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

The Investigator team hypothesizes that in a randomized trial comparing mifepristone-alone or misoprostol-alone for cervical preparation for procedural abortions at 12 to 16 weeks in hospital-based care, the proportion of patients who achieve successful cervical dilation will be different between the study groups.

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.

What data supports the idea that Mifepristone vs Misoprostol for Cervical Preparation is an effective drug?

The available research shows that using mifepristone along with misoprostol for cervical preparation can be effective. One study found that this combination can reduce blood loss during surgical abortions between 12 and 14 weeks of pregnancy compared to using either drug alone. Another study indicated that mifepristone helps in making the cervix softer, which is important for the procedure. Additionally, mifepristone has been shown to be effective in preparing the cervix for second-trimester pregnancy terminations, suggesting its usefulness in this context. ^{1 2 3 4 5}

What safety data exists for Mifepristone and Misoprostol in cervical preparation?

Mifepristone and Misoprostol have been studied extensively for their use in pregnancy termination and cervical preparation. Studies show that Mifepristone is safe and effective, with no serious complications or side effects reported in trials. It improves cervical dilation and reduces perioperative blood loss. Misoprostol, when used with Mifepristone, has shown high efficacy rates and is considered safe when guidelines are followed. Some side effects like pelvic pain and malaise are reported, but serious adverse events are rare. Overall, both drugs are considered safe for cervical preparation when used as directed. ^{2 6 7 8 9}

Is the drug Mifepristone, Misoprostol a promising treatment for cervical preparation?

Yes, Mifepristone and Misoprostol together are promising for cervical preparation. They help reduce blood loss and complications during surgical abortions, making the process safer and more effective. ^{1 4 10 11 12}

Research Team

Antoinette Danvers, MD, MSCR, MBA

Principal Investigator

Montefiore Medical Center

Eligibility Criteria

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

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

Seeking induced abortion of a singleton pregnancy

I speak English or Spanish.

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.

Trial Timeline

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)

Treatment Details

Interventions

• Mifepristone (Corticosteroid)
• Misoprostol (Prostaglandin)

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.

Participant Groups

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 Canada for the following indications:

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+

Findings from Research

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]

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]

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]

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 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]

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]

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 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]

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]

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]

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]

References

1. Ireland 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. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Mifepristone (RU486) and therapeutic late pregnancy termination: a double-blind study of two different doses. [2019]

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

Efficacy of mifepristone for cervical priming for second-trimester surgical termination of pregnancy. [2016]

4. United States 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. [2018]

5. Australia pubmed.ncbi.nlm.nih.gov

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

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

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

7. England pubmed.ncbi.nlm.nih.gov

RU486: the French experience. [2019]

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

Mifepristone (RU 486): current knowledge and future prospects. [2019]

9. England pubmed.ncbi.nlm.nih.gov

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

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

Comparison between vaginal misoprostol and cervical dinoprostone for cervical ripening and labor induction. [2013]

11. Denmark pubmed.ncbi.nlm.nih.gov

[Reintroduction of medical abortion in Denmark]. [2014]

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

Use of misoprostol in first and second trimester abortion: a review. [2019]