he pill in Japan: will approval ever come?
Once-a-month treatment with a combination of mifepristone and the prostaglandin analogue misoprostol.
In this two centre study, the efficacy of 200 mg mifepristone orally followed 48 h later by 0.4 mg misoprostol orally for menstrual regulation was investigated. The dose of mifepristone was taken the day before the expected day of menstruation. Each volunteer was planned to participate for up to 6 months. A plasma beta human chorionic gonadotrophin (HCG) was measured on the day of mifepristone intake. The study was disrupted prematurely due to low efficacy. In 125 treatment cycles the overall pregnancy rate was 17.6% (22 pregnancies) and the rate of continuing pregnancies (failure) was 4.0%. Eight women discontinued the study due to bleeding irregularities which were seen in 15 cycles (12%). These effects on bleeding pattern made the timing of treatment day difficult. Late luteal phase treatment with a combination of mifepristone and misoprostol is not adequately effective for menstrual regulation. (+info)
Agreeing criteria for audit of the management of induced abortion: an approach by national consensus survey.
OBJECTIVE: To obtain a national consensus view of suggested criteria for good quality care in induced abortion to serve as a basis for standards for audit to assess current clinical practice. DESIGN: Postal, questionnaire survey assessing consensus agreement with criteria identified from a literature review and refined by an invited panel of four gynaecologists and the gynaecology audit project in Scotland (GAPS) committee. SETTING: Scotland. SUBJECTS: All 132 practising consultant gynaecologists. MAIN MEASURES: Overall level of agreement with each of 20 suggested audit criteria. RESULTS: 121 completed questionnaires were received (response rate 92%), of which 119 were returned in time for analysis; 107 came from consultants who practised abortion routinely and were included in the analysis. Nineteen of 20 suggested criteria were validated by an overall balance of agreement. The most strongly supported criterion (agreement score +93) was for ascertaining rhesus status of the woman and prophylaxis after abortion, if indicated. The only criterion to elicit a negative agreement score (-27) was that dilatation and evacuation is the best method of abortion at 12-15 weeks' gestation. The ranked and prioritised criteria resulting from this exercise are being used within a national audit project. CONCLUSIONS: A postal questionnaire survey among interested clinicians resulted in a good response rate and enabled the audit criteria to be validated and ranked more objectively and among more clinicians, than would have been possible by group discussion. (+info)
Impact of a national audit project on gynaecologists in Scotland.
The objectives of the study were (a) to determine consultant gynaecologists' awareness of and views on a national audit project (the gynaecology audit project in Scotland) and (b) to measure changes in their reported practice in relation to 12 specific elements of care related to three audit topics (induced abortion, endometriosis, and vulvar carcinoma) for which recommendations for change had been made within the project. The study comprised a postal questionnaire survey of all 128 consultant gynaecologists in NHS practice in Scotland. The response rate was 90%. Of the respondents, 96% (109/113) recalled receiving feedback material from the audit project team and around 75% (range 66/89 to 84/105) had retained feedback reports for future reference. For the two more common clinical topics (induced abortion and endometriosis), over two thirds of the respondents indicated that they had been prompted to reconsider or change aspects of practice. Significant changes in reported practice, in line with project recommendations, were found for seven of the 12 specific elements of care examined. Thus, gynaecologists in Scotland showed a high level of awareness of and positive views towards a national audit project. Significant changes in reported practice, in accordance with circulated recommendations, were measurable in relation to several elements of clinical care. (+info)
Complications of unsafe abortion in sub-Saharan Africa: a review.
The Commonwealth Regional Health Community Secretariat undertook a study in 1994 to document the magnitude of abortion complications in Commonwealth member countries. The results of the literature review component of that study, and research gaps identified as a result of the review, are presented in this article. The literature review findings indicate a significant public health problem in the region, as measured by a high proportion of incomplete abortion patients among all hospital gynaecology admissions. The most common complications of unsafe abortion seen at health facilities were haemorrhage and sepsis. Studies on the use of manual vacuum aspiration for treating abortion complications found shorter lengths of hospital stay (and thus, lower resource costs) and a reduced need for a repeat evacuation. Very few articles focused exclusively on the cost of treating abortion complications, but authors agreed that it consumes a disproportionate amount of hospital resources. Studies on the role of men in supporting a woman's decision to abort or use contraception were similarly lacking. Articles on contraceptive behaviour and abortion reported that almost all patients suffering from abortion complications had not used an effective, or any, method of contraception prior to becoming pregnant, especially among the adolescent population; studies on post-abortion contraception are virtually nonexistent. Almost all articles on the legal aspect of abortion recommended law reform to reflect a public health, rather than a criminal, orientation. Research needs that were identified include: community-based epidemiological studies; operations research on decentralization of post-abortion care and integration of treatment with post-abortion family planning services; studies on system-wide resource use for treatment of incomplete abortion; qualitative research on the role of males in the decision to terminate pregnancy and use contraception; clinical studies on pain control medications and procedures; and case studies on the provision of safe abortion services where legally allowed. (+info)
A randomized double-blind placebo-controlled study to assess the effect of oral contraceptive pills on the outcome of medical abortion with mifepristone and misoprostol.
This was a randomized double-blind placebo-controlled trial to determine the effect of oral contraceptive (OC) pills taken immediately after medical abortion on the duration of bleeding and complete abortion rate. Two hundred women in the first 49 days of pregnancy were given 200 mg mifepristone orally followed by 400 microg misoprostol vaginally 48 h later. One day later, they were randomized to receive either OC pills (30 microg of ethinyl oestradiol and 0.15 mg of levonorgestrel per tablet) or placebo for 21 days. The complete abortion rates were 98% in the OC group and 99% in the placebo group. The median duration of bleeding was similar: 17 (range: 5-57) days in the OC group and 16 (range: 6-55) days in the placebo group. In the OC group there was a small but significant fall in the haemoglobin concentration by 14 days (5.3 g/dl) after administration of mifepristone. The incidence of side-effects was similar in the two groups. We conclude that the use of OC pills does not decrease the duration of bleeding after medical abortion nor does it affect the abortion rate. (+info)
Contraceptive failure rates: new estimates from the 1995 National Survey of Family Growth.
CONTEXT: Unintended pregnancy remains a major public health concern in the United States. Information on pregnancy rates among contraceptive users is needed to guide medical professionals' recommendations and individuals' choices of contraceptive methods. METHODS: Data were taken from the 1995 National Survey of Family Growth (NSFG) and the 1994-1995 Abortion Patient Survey (APS). Hazards models were used to estimate method-specific contraceptive failure rates during the first six months and during the first year of contraceptive use for all U.S. women. In addition, rates were corrected to take into account the underreporting of induced abortion in the NSFG. Corrected 12-month failure rates were also estimated for subgroups of women by age, union status, poverty level, race or ethnicity, and religion. RESULTS: When contraceptive methods are ranked by effectiveness over the first 12 months of use (corrected for abortion underreporting), the implant and injectables have the lowest failure rates (2-3%), followed by the pill (8%), the diaphragm and the cervical cap (12%), the male condom (14%), periodic abstinence (21%), withdrawal (24%) and spermicides (26%). In general, failure rates are highest among cohabiting and other unmarried women, among those with an annual family income below 200% of the federal poverty level, among black and Hispanic women, among adolescents and among women in their 20s. For example, adolescent women who are not married but are cohabiting experience a failure rate of about 31% in the first year of contraceptive use, while the 12-month failure rate among married women aged 30 and older is only 7%. Black women have a contraceptive failure rate of about 19%, and this rate does not vary by family income; in contrast, overall 12-month rates are lower among Hispanic women (15%) and white women (10%), but vary by income, with poorer women having substantially greater failure rates than more affluent women. CONCLUSIONS: Levels of contraceptive failure vary widely by method, as well as by personal and background characteristics. Income's strong influence on contraceptive failure suggests that access barriers and the general disadvantage associated with poverty seriously impede effective contraceptive practice in the United States. (+info)
Prenatal diagnosis and discrimination against the disabled.
Two versions of the argument that prenatal diagnosis discriminates against the disabled are distinguished and analysed. Both are shown to be inadequate, but some valid concerns about the social effects of prenatal diagnosis are highlighted. (+info)