Options expand in wait for mifepristone arrival
As the wait continues for the U.S. introduction of mifepristone, providers are considering other options of very early abortion.
The Danco Group in New York City, which is bringing the drug to the American market, is arranging manufacturing details and getting information to the U.S. Food and Drug Adminis tration (FDA) in hopes of securing final agency approval by the end of 1999, reports Christina Horzepa, a spokeswoman for the Population Council, also in New York City. The council, which holds the patent for the drug, has licensed Danco to manufacture and market mifepristone in the United States.
Just more than half of obstetricians/gynecologists and 45% of family practice physicians say they would offer mifepristone if it is approved, according to a national survey commissioned by the Kaiser Family Foundation of Menlo Park, CA. An equal number of nurse practitioners and physician assistants say they also would offer the drug. (Is your facility considering offering mifepristone, methotrexate, or manual vacuum aspiration abortions? Contraceptive Technology Update will offer information from current providers in a special two-part series beginning next month.)
Nearly one in five OB/GYNs, including 11% of those who say they never perform surgical abortions, say they are likely to offer methotrexate abortions in the next year. Thirteen percent of nurse practitioners and physician assistants and 11% of family practice physicians report plans to offer the drug, according to the survey’s findings.
Methotrexate, originally approved by the FDA as a cancer treatment in 1953, is no longer patented and is widely available. It was first used "off-label" in gynecology as a medical treatment for ectopic tubal pregnancies.
In the last five years, much research has focused on the intramuscular administration of methotrexate, followed by the vaginal administration of misoprostol, for use in medical abortions. A number of published studies have shown the safety and efficacy of the method, using 50mg/m2 injection of methotrexate, followed by vaginal insertion of 800 µg of misoprostol tablets.1-5 This regimen has proven effective in more than 90% of the cases. (See Contraceptive Technology Update, Septem ber 1998, pp. 114 and 119, for more details.)
Early surgical options
Vacuum aspiration, which relies on suction to extract contents of a pregnancy from the uterus, has been the most common method used for first-trimester abortions. The advent of ultra-sensitive urine tests and ultrasound technology now allow women to seek abortions to do so earlier in their pregnancies. Manual vacuum aspiration has been used safely and effectively both for termination of pregnancy and management of incomplete abortion in dozens of countries for more than 20 years, says Paul Blumenthal, MD, associate professor in the OB/GYN department at Johns Hopkins University in Baltimore.
Interest in manual vacuum aspiration has increased since Jerry Edwards, MD, medical director of Planned Parenthood in Houston, published results using the technique in very early pregnancy.6 With this technique, women can take a pregnancy test as soon as eight days after unprotected sex. Using ultrasound to confirm the results, the provider uses a handheld syringe and canula to remove the fertilized egg.
For the provider who does not perform abortions on a regular basis, the basic equipment required to perform manual vacuum aspirations is so minimal that it can be kept in a drawer in any GYN office, says Carolyn Westhoff, MD, DSc, medical director of family planning at Columbia Presbyterian Medical Center and associate professor of clinical OB/GYN and public health at Columbia University, both in New York City. Such availability can allow providers outside a dedicated clinic environment to take care of their patients in a safe, effective manner.
Another advantage to manual vacuum aspiration lies in its unobtrusiveness, Westhoff points out. It is less intimidating for some patients because it is less noisy and does not require a machine for the suction. Very early abortions also can be performed with electric suction, she notes, and many providers may chose to use it later in the trimester. The manual method affords another option, one that can be used outside a dedicated abortion clinic setting.
The range of improved options for very early abortion is one that both providers and women will welcome and may improve women’s overall health by encouraging them to seek care earlier in their pregnancies, says Felicia Stewart, MD, director of reproductive health programs at the Kaiser Foundation. Such expansion of services are needed to overcome the barriers to abortion access. Eighty-four percent of all U.S. counties lacked an abortion provider in 1992.7 One-quarter of women who have nonhospital abortions travel at least 50 miles from their home to the abortion facility.8
"These are all methods that are very safe and quite straightforward so that physicians in normal family practice settings or clinicians and physician assistants would find it feasible," Stewart notes. "That certainly could have the potential of increasing access to services."
References
1. Creinin MD, Darney PD. Methotrexate and misoprostol for early abortion. Contraception 1993; 48:339-348.
2. Creinin MD, Vittinghoff E. Methotrexate and misoprostol vs misoprostol alone for early abortion. A randomized controlled trial. JAMA 1994; 272:1,190-1,195.
3. Creinin MD, Vittinghoff E, Galbraith S, et al. A randomized trial comparing misoprostol three and seven days after methotrexate for early abortion. Am J Obstet Gynecol 1995; 173:1,578-1,584.
4. Schaff EA, Eisinger SH, Franks P, et al. Combined methotrexate and misoprostol for early induced abortion. Arch Fam Med 1995; 4,774-4,779.
5. Creinin MD, Vittinghoff E, Keder L, et al. Methotrexate and misoprostol for early abortion: a multicenter trial. 1. Safety and efficacy. Contraception 1996; 53:321-327.
6. Edwards J, Carson SA. New technologies permit safe abortion at less than six weeks’ gestation and provide timely detection of ectopic gestation. Am J Obstet Gynecol 1997; 176:1,101-1,106.
7. Henshaw S, Van Vort J. Abortion Services in the United States, 1991 and 1992. Family Plann Perspect 1994; 26:100-106, 112.
8. Henshaw S. Factors Hindering Access to Abortion Services. Family Plann Perspect 1995; 27:54-59, 87.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content