-- A PARTICIPANT in clinical trials of RU-486 felt the drug would be preferable to surgery and describes the process other women will go through now that it has U.S. approval. By Marc Kaufman
When Amy found out she was pregnant a year ago, she went to a clinic near her Seattle-area home and asked if she could use the abortion drug RU-486, even though it had not received U.S. government approval.
The 36-year-old mother and university laboratory worker thought RU-486 would give her greater control, allowing her to be home with her husband instead of at an abortion clinic. And Amy, who had terminated a pregnancy when she was 16, also found the idea of a drug-induced abortion more appealing than a surgical procedure.
With the FDA's announcement Thursday that the drug had been approved in the United States after years of bitter debate, Amy's experience provides a glimpse into what many American women likely will be going through. Using the abortion pill was more difficult than Amy had anticipated, but she is glad she did it.
"It's not an easy experience, and it seems very important to have good support around you," said Amy, who asked that her last name be withheld. "But I'm comfortable with the decisions I made and am glad that I had a medical abortion."
Since clinical trials for RU-486 began in the United States in 1994, more than 10,000 American women have used the drug for abortions. Surveys have found that 88 percent of those women felt their abortions were very or moderately satisfactory, and 95 percent who used the drug in trials said they would recommend it to others.
The clinic Amy went to referred her to another in the area testing the drug. Amy met requirements for RU-487 or mifepristone use: She was less than 49 days from her last menstrual period, did not have an ectopic pregnancy, had no bleeding problems and did not have an inserted IUD or certain kidney or liver conditions. The drug is not believed to be as safe or effective for women more than 49 days from their last period.
Exact dosages used in U.S. tests have varied, and some of the women aborted in hospitals or doctor's offices and some at home. But the basic regimen has been the same:
During her first visit, a doctor counseled Amy about how the abortion would work and what to expect. One of the strongest messages was that if she took the first pill, she would need to take the second. The first pill ends the pregnancy, but Amy's health would be threatened if she didn't take the second pill to expel the embryo.
Amy underwent an ultrasound test to determine the exact age of the embryo, and then she was given mifepristone and sent home.
The FDA has approved a protocol calling for 600 milligrams of the drug, but in studies such as Amy's, women typically have received 200 milligrams.
The mifepristone blocks progesterone, a hormone needed to maintain a pregnancy. Without it, the lining of the uterus softens and begins to break down, and bleeding can begin. That part was easy, Amy said. She did not feel much from taking RU-486 alone.
Amy took a second drug, called misoprostol, two days later to trigger contractions designed to expel the developing embryo. Most women will return to their doctors for the second pill; Amy got hers at the first visit. While the protocol the FDA approved Thursday calls for women to take misoprostol pills, Amy's study called for vaginal insertion of the hormone.
Amy started cramping after about 30 minutes and had two to three hours of sharp, menstrual-like cramps that kept her lying down with her knees up or running to the bathroom, she said. The contractions were close and constant as the embryo was expelled along with numerous blood clots. (Amy said that she saw nothing that appeared to be the embryo.) She also had heavy blood flow for the five days that followed.
Most women experience cramps that range from moderate to severe, said Paul Blumenthal, medical director of Maryland Planned Parenthood. As a result, most women are given some pain relief, such as ibuprofen with codeine, although many find they don't need it, he said.
In studies, about 6 percent of women expelled the embryo with mifepristone alone, 44 percent within four hours of taking misoprostol and 63 percent within 24 hours.
Amy returned to the clinic several weeks later to make sure the abortion had been successful. A small percentage of women--between 2 percent and 8 percent--experience excessive bleeding or do not abort successfully with the drug regimen and must undergo a surgical abortion. As a result, the FDA regulations require doctors dispensing RU-486 to be either trained in surgical abortions or have a referring relationship with a trained doctor.
Amy had another ultrasound test and was asked questions to determine if she was physically and emotionally well. Everything had gone smoothly for her.
Despite the pain and discomfort, Amy remains convinced she made the right choice.
"I felt like I was carrying it out myself. It probably was more uncomfortable (than a surgical abortion) but then someone else is doing that to me, and I didn't want that," she said.
"It felt morally right," added Amy, who has a 5-year-old son. "I think all women should have that same option."