Women find mifepristone safe, acceptable method
Nine of 10 U.S. women who used the mifepristone/misoprostol regimen for medical abortion say they would choose the method again and would recommend its use to friends, findings from a national multi-center trial confirm.1
With both safety/efficacy and acceptability data now in hand, another step has been made in the eventual U.S. debut of the drug. (See Contra cep tive Technology Update, July 1998, pp. 87-88, for details on the safety and efficacy study.2 This earlier U.S. study reported an efficacy rating of 92% up to 49 days after last menstrual period, comparable to the 95% rate found in the majority of European studies.) Danco Group, the New York City company assigned by the Population Council to deliver the drug, has said it expects government approval and availability on the market in 1999, notes Population Council spokeswoman Sandra Waldman.
More than 2,100 women took part in the multi-center trials, says Beverly Winikoff, MD, MPH, director of reproductive health at the New York City-based Population Council and lead author of the acceptability study. The majority was overwhelmingly favorable toward the regimen, even if they experienced a failure, a finding that echoes a large international study conducted by Winikoff and other Population Council researchers.3
"It is very important, I think, to know that women really want this alternative," notes Winikoff. "We can say in the abstract, 'Oh yes, it is more inconvenient' or 'It's bleeding' or 'It's more pain,' but in the end, if women are going to make the choice and they prefer this, who's to second-guess that? If it's safe, it's safe. It's good to let women speak a bit and not just try to judge it in a professional way for women."
During their final clinic visit, women were asked to list the best and worst features of the mifepristone/misoprostol regimen. Positive features included no surgery and/or injections; natural, feminine; similar to menses or miscarriage; less pain; easier emotionally; less frightening; and easier, simpler, and faster. The negative aspects related to feared as well as actual side effects, which women did not distinguish in their remarks. These included pain or cramping, waiting, uncertainty or fear of the unknown, and feared or actual nausea, vomiting, and diarrhea.
"Women said that they specifically wanted to avoid surgery," Winikoff says. "The things that were difficult for women had to do with the bleeding, the fear of failure because they knew it might not work, and the multiple clinic visits and the waiting time in the clinic."
While almost all the women said they felt the method had been thoroughly explained through counseling, about half said their experience differed from their expectations. When questioned further, two-thirds said the experience was better than expected, while the remaining third found it to be worse than expected. Those who found success with the method were more likely to classify the method as better than expected.
Winikoff says the difference in expectation and experience may be a result of providers' attempts to prepare women for multiple outcomes in testing a new regimen. "We don't know what it is that the provider said [prior to the regimen]. "I think it may have been the fear of failure because if you say, 'We don't know quite what the success rate will be - somewhere over 90%,' people worry that they are going to be a failure. If they are not a failure, then the whole experience is much better than what they expected."
About half of the women in the clinical trial had had a previous surgical abortion. Of that group, more than 75% of them said medical abortion was more satisfactory than their earlier experience. For those patients who had method failures, 45% said their experience was more satisfactory then their previous surgical abortion, and 37% termed it less satisfactory.
As providers become more experienced with the mifepristone/misoprostol regimen, they will be able to give women a more realistic picture of what the process entails, Winikoff says. "It was very hard at the outset, when it was brand-new technology both to the providers and the consumers, to tell women what to expect and to give women sort of an appropriate feel for when they should be calling back due to problems."
Providers who have continued to work with the method are getting more of a sense of the regimen, and now they can more adequately answer such questions as "how much bleeding is too much bleeding?" she says.
"I don't think it takes too long, maybe 20 cases, to get a very good idea," Winikoff observes. "It was very new when we started this study."
(Editor's note: Medical abortion research continues in the use of methotrexate, a drug currently approved by the federal Food and Drug Administration for cancer treatment. For details, see story at right.)
References
1. Winikoff B, Ellertson C, Elul B, et al. Acceptability and feasibility of early pregnancy termination by mifepristone-misoprostol. Arch Fam Med 1998; 7:360-366.
2. Spitz IM, Bardin CW, Benton L, et al. Early pregnancy termination with mifepristone and misoprostol in the United States. N Engl J Med 1998; 338:1,241-1,247.
3. Winikoff B, Sivin I, Coyaji KJ, et al. Safety, efficacy, and acceptability of medical abortion in China, Cuba, and India: a comparative trial of mifepristone-misoprostol versus surgical abortion. Am J Obstet Gynecol 1997; 176:431-437.
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