Early Options: Module 1 - Pharmacological Approaches to Early Abortion

Early Options - A Provider's Guide to Medical Abortion

The on-line CME post-test will follow this module. However, we strongly urge you to print out the CME Post-Test Questions before starting this module to help guide you through the material.

Objectives
Upon completion of this module, you should be able to:
1. Describe safety and efficacy data for the FDA-approved mifepristone/misoprostol regimen
2. Describe safety and efficacy data for evidence-based alternative, or off-label, mifepristone/misoprostol regimens and for the methotrexate/misoprostol regimen
3. List the eligibility requirements for and contraindications to medical abortion with mifepristone/misoprostol
4. Discuss protocols for medical abortion with mifepristone/misoprostol
5. Describe expected side effects and possible complications

Introduction
On September 28, 2000, the U.S. Food and Drug Administration (FDA) granted final approval to mifepristone in combination with misoprostol for medical abortion. Mifepristone is an antiprogestin. Withdrawal of progesterone during early pregnancy leads to expulsion of the embryo via a prostaglandin-mediated mechanism.

Misoprostol, a prostaglandin (PG) analogue administered after mifepristone, increases the efficacy of treatment by inducing uterine contractions.

The FDA-approved ("standard") regimen for medical abortion includes mifepristone 600 mg administered orally (PO) followed 2 days later by misoprostol 400 µg PO for pregnancies through 49 days' gestation. This regimen has been used for early abortion by hundreds of thousands of women with success rates of 92% to 97%.

A number of evidence-based, off-label treatment variations have emerged as researchers study other regimens that may prove simpler than the FDA-approved approach and may serve a larger number of women.

Investigators have studied the impact, safety, and efficacy of different mifepristone doses, administration of vaginal misoprostol, home use of misoprostol, extension of the gestational age limit for medical abortion, and variations in the timing of medications and follow-up. In addition, the role of ultrasonography in medical abortion practice remains an important focus of inquiry.

During the 1990s, when access to mifepristone in the United States was restricted, researchers also investigated alternative drug regimens, such as the combination of methotrexate and misoprostol.

Modern medical approaches to induced abortion have an impressive efficacy and safety record. Nevertheless, the success of the procedure depends on women complying with a specific set of treatment instructions over a time period of several days. Therefore, patient counseling plays a central role in medical abortion.

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Proceed to Mifepristone and Misoprostol - Pharmacology and Mechanism of Action.

References for this module