The risks of oral contraceptive pills.

Oral contraceptive pills have been associated with increased risk for myocardial infarction, stroke, and venous thromboembolism. Studies have been published recently that suggest that these risks are minimal in appropriately chosen low-risk women. Stroke is a very uncommon event in childbearing women, occurring in approximately 11 per 100,000 women over 1 year. Thus, even a doubling of this risk with oral contraceptive pills would have minimal effect on attributable risk. The estimated risk of myocardial infarction associated with oral contraceptive pill use in nonsmokers is 3 per million women over 1 year. The estimated risk of venous thromboembolism attributable to oral contraceptive pills is less than 3 per 10,000 women per year. Additionally, the literature suggests that there may be an increased risk of breast cancer associated with long-term oral contraceptive pill use in women under the age of 35. However, because the incidence of breast cancer is so low in this population, the attributable risk of breast cancer from birth control pill use is small.

Mifepristone followed on the same day by vaginal misoprostol for early abortion.

We performed a pilot study to examine the clinical efficacy of mifepristone 200 mg followed on the same day by misoprostol 800 microg vaginally in women with pregnancies up to 49 days gestation. Forty women received mifepristone 200 mg after which they self-inserted misoprostol intravaginally 6 to 8 h later at home. Participants returned for an evaluation, including transvaginal ultrasonography, 24 +/- 1 h after using the misoprostol. Participants who had not aborted received a second dose of misoprostol to administer 48 h after the mifepristone. All participants returned approximately 2 weeks after receiving mifepristone. At 24 h after receiving misoprostol, 37/40 (92%, 95% CI 81-98%) had ultrasonographic evidence of complete abortion. By follow-up 2 weeks after the mifepristone, 40/40 (100%, 95% CI 92-100%) women were felt to have complete abortions. One subject subsequently had a suction aspiration for an incomplete abortion on study Day 44. Nausea, vomiting, diarrhea, and warmth/chills occurred in 38%, 13%, 13%, and 60%, respectively. This pilot study suggests that mifepristone 200 mg, followed on the same day by misoprostol 800 microg vaginally, effects abortion at rates comparable to regimens using the standard time interval of 48 h between medications.

Mifepristone 100 mg in abortion regimens.

OBJECTIVE: To examine the clinical efficacy of mifepristone 100 mg followed 2 days later by misoprostol 400 microg orally or 800 microg vaginally in women at up to 49 days' gestation. METHODS: Eighty participants received mifepristone 100 mg and then were randomized to misoprostol, administered 48 hours later, at a dose of 400 microg orally (group 1) or 800 microg vaginally (group 2). Women returned for follow-up evaluations 24 +/- 1 hour after using the misoprostol and then 2-3 weeks later. If abortion still had not occurred and the pregnancy was nonviable, the subject returned again after an additional 3 weeks. RESULTS: Twenty-four hours after receiving misoprostol, 34 (85%; 95% confidence interval [CI] 71%, 94%) of the 40 women in group 1 and 38 (95%; 95% CI 85%, 99%) of the 40 women in group 2 had complete abortions. Overall, complete abortion without surgical intervention occurred in 34 women in group 1 (85%; 95% CI 71%, 94%) and 40 women in group 2 (100%; 95% CI 91%, 100%; P =.03). Four women in group 1 required suction aspiration for continuing pregnancy at the second follow-up, compared with none in group 2 (P =.12). Side effects occurred with similar frequency in both treatment groups. CONCLUSION: Low-dose mifepristone (100 mg) combined with vaginal misoprostol 800 microg may be an effective alternative to regimens using 200 or 600 mg of mifepristone with misoprostol.

Efficacy of mifepristone followed on the same day by misoprostol for early termination of pregnancy: report of a randomised trial.

OBJECTIVE: To examine the clinical efficacy of mifepristone 600 mg followed on the same day or two days later by misoprostol 400 microg orally in women undergoing medical termination of pregnancy whose pregnancies have a gestational age up to 49 days. DESIGN: Prospective, randomised trial. SETTING: Clinical research office. PARTICIPANTS: Eighty-six women, requesting elective termination of a pregnancy which has a gestational age of < or = 49 days. METHODS: After administration of mifepristone 600 mg, participants were randomised to take misoprostol six to eight hours later (Group 1) or 48 hours later (Group 2). Women returned for a follow up evaluation 24 +/- 1 hours after taking the misoprostol. Participants in Group 1 who had not aborted received a second dose of misoprostol to take 48 hours after the mifepristone. All women returned approximately two weeks after receiving mifepristone. If termination of pregnancy had still not occurred and the pregnancy was non-viable, the woman returned again in three weeks. MAIN OUTCOME MEASURES: Rate of complete abortion 24 hours after administration of misoprostol. RESULTS: At 24 hours after receiving misoprostol, 21/42 (50%, 95% CI 35%, 65%) women in Group I and 40/44 (91%, 95% CI 82%, 99%) women in Group 2 had complete abortions. By follow up two weeks later after the administration of mifepristone, 40/42 (95%, 95% CI 89%, 100%) women in Group 1 and 43/44 (98%, 95% CI 93%, 99%) women in Group 2 were known to have complete abortions. Nausea, vomiting or diarrhoea in women using the standard regimen (Group 2) occurred in 68%, 36%, and 20%, respectively. CONCLUSIONS: After treatment with mifepristone 600 mg, administration of misoprostol 400 microg orally on the same day is not as effective at causing abortion within the first 24 hours compared with the standard time interval of 48 hours between medications.

Early pregnancy failure--current management concepts.

Approximately one in four women will experience a miscarriage during her lifetime. For more than 50 years, the standard management of early pregnancy failure has been a dilatation and curettage (D & C). Typically, the procedure is performed in an operating room, which significantly increases cost. There is little objective information in the modem literature to prove that a D & C for all patients will lower morbidity or improve emotional well being. Treatment options include expectant management, D & C in an outpatient setting, and medical management with misoprostol (not approved by the U.S. Food and Drug Administration for treatment of early pregnancy failure). The medical literature supports that expectant management may result in more complications, including the need for "emergent" curettage, if clinicians do not understand the true normal course of expectant management. In general, women prefer some form of active management. Dilatation and curettage can be performed safely in the office or other outpatient setting using manual vacuum aspiration. Vaginal misoprostol will cause expulsion in 80% to 90% of women up to 13 weeks' uterine size or gestation, including patients who have a gestational sac present. However, these data come from only three trials involving a total of 42 subjects treated with vaginal misoprostol, and another study of 42 women who received vaginal misoprostol for "missed abortion" before a scheduled D & C. There is a significant lack of information from large-scale studies about when treatment is necessary and the relative efficacy, rates of side effects, and acceptability of these various treatment options for early pregnancy failure.

Alternatives to mifepristone regimens for medical abortion.

Alternatives to regimens with mifepristone and a prostaglandin analog for medical abortion emerged because of the need for accessible, effective, and safe options in areas of the world where mifepristone was unavailable. Studies of oral or intramuscular methotrexate combined with misoprostol have demonstrated complete abortion rates in the same range as mifepristone regimens at

Medical abortion alternatives to mifepristone.

Social and political constraints have prohibited the use of mifepristone in most countries. As a result, researchers, clinicians, and women throughout the world have pushed for the development of alternative medical abortion regimens. Methotrexate (both oral and intramuscular) combined with misoprostol has been under investigation since 1993, with complete abortion rates similar to mifepristone regimens for pregnancies up to 49 days' gestation. Thousands of women have had safe medical abortions in their own homes using these medications. The overall abortion process using methotrexate and misoprostol takes longer, however, with 20% to 30% of women waiting up to five weeks for the abortion to occur. More recently, misoprostol-only regimens have been proposed for medical termination of pregnancy. The efficacy of these misoprostol regimens has been reported in the same range as those combining mifepristone or methotrexate with misoprostol, although other investigators have been unable to confirm these results. Additionally, a few small studies have tested tamoxifen combined with misoprostol, with mixed results. Continued research is necessary to ensure that reported efficacy rates for all proven medical abortion regimens are true for various populations of women.

"Pop-out" method of levonorgestrel implant removal.

The "pop-out" technique is a method of levonorgestrel implant removal that uses digital pressure to direct implants through a small skin incision. This technique was developed, theoretically, to cause less bruising and patient discomfort by avoiding the use of instruments. The pop-out technique is the primary method used for levonorgestrel implant removal in the Magee-Womens Hospital resident clinic. We performed a retrospective analysis of levonorgestrel implant removals performed between July 1, 1995, and December 31, 1998. Of the 168 removals included in this analysis, 38 were performed by one of two attending physicians, and 130 were performed by the residents with attending supervision. The average time for removal was 12 +/- 5 min (range 2.25-27 min) when the "pop-out" method could be used to remove all six implants, and 14 +/- 7 min (range 2.25-59 min) for all removals. The removal time for residents was inversely proportional to the anticipated level of difficulty of the removal and to the number of previous removals performed. The removal time was significantly faster when residents were supervised by one of the attending physicians as compared with the other attending physician. Only 0.7% (7/1,008) of levonorgestrel implants were fragmented during removal. This review shows that the "pop-out" method is a reasonable alternative to other proposed methods of primary implant removal. The difference in the level of expertise of the attending physician may significantly influence removal time when training clinicians in levonorgestrel implant removal.

PIP: A retrospective analysis was conducted to describe physicians¿ experience with the "pop-out" method for levonorgestrel implant removal. 168 women at Magee-Women's Hospital between July 1, 1995, and December 31, 1998, were included in the analysis. The method of implant removal, the "pop-out" technique, uses digital pressure to direct implants through a small skin incision. This was developed to decrease bruising and discomfort by avoiding the use of instruments. The results showed that the average time for removal was 12 +or- 5 minutes (range, 2.25-27 minutes), when the "pop-out" method could be used to remove all 6 implants, and 14 +or- 7 minutes for all removals. The removal time for a resident physician was inversely proportional to the anticipated level of difficulty of the removal and to the number of previous removals performed. Supervision by one of the attending physicians resulted in significantly faster removal time. Only 0.7% (7/1800) of levonorgestrel implants were fragmented during removal. This study proved that the "pop-out" method is a reasonable alternative to other proposed procedures of primary implant removal. When training clinicians in levonorgestrel implant removal, the difference in the level of expertise of the attending physician would significantly affect removal time.

The trimonthly combination oral contraceptive regimen: is it cost effective?

The extended use of combination oral contraceptive pills (COCPs) to decrease the frequency of withdrawal bleeding can be convenient and beneficial to women. We conducted a cost-effective analysis comparing the standard regimen (21 days of estrogen/progestin) to a trimonthly regimen (84 days of estrogen/progestin) followed by a pill-free week for 1-year. The economic savings for patient out-of-pocket expenses from decreased sanitary product usage as a result of nine fewer withdrawal bleeding episodes is offset by the cost of three extra packages of COCPs from the trimonthly regimen. On the basis of an average use of 18 tampons per month, the trimonthly regimen is cost effective when the patient cost per package of pills is less than $9.45. The trimonthly regimen is also cost effective when the sanitary product usage is in the higher range; an above average use of 48 tampons per month is cost effective when the patient cost per package of pills is less than $25.20. Therefore, the trimonthly regimen may be useful for women with menorrhagia, but for the average women, the qualitative benefits of less frequent withdrawal bleeding need to be weighed against an increase in cost.

PIP: The extended use of combination oral contraceptives (COCs) to decrease the frequency of withdrawal bleeding can be convenient and beneficial to women. The authors conducted a cost-effective analysis comparing the standard regimen (21 days of estrogen/progestin) to a trimonthly regimen (84 days of estrogen/progestin) followed by a pill-free week for 1-year. The economic savings for patient out-of-pocket expenses from decreased sanitary product usage as a result of 9 fewer withdrawal bleeding episodes is offset by the cost of three extra packages of COCs from the trimonthly regimen. On the basis of an average use of 18 tampons per month, the trimonthly regimen is cost-effective when the patient cost per package of pills is less than $9.45. The trimonthly regimen is also cost-effective when the sanitary product usage is in the higher range; an above average use of 48 tampons per month is cost-effective when the patient cost per package of pills is less than $25.20. Therefore, the trimonthly regimen may be useful for women with menorrhagia, but for the average women, the qualitative benefits of less frequent withdrawal bleeding need to be weighed against an increase in cost.