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Mifepristone (an antiprogesterone) and misoprostol (a synthetic analogue of prostaglandin E1) were administered to 60 women diagnosed with missed abortion or anembryonic pregnancy (gestation sac present but no developing embryo) equivalent to 13 weeks' gestation or less who were recruited after counselling. The median age was 227 (range 15-44), and the median duration of amenorrhoea was 71 (42-110) days. 25 of the women had been referred for ultrasound scanning because of bleeding in early pregnancy, while the rest were diagnosed by routine scanning. 29 patients had anembryonic pregnancies, and 31 had a missed abortion. Each patient received a 600 mg single oral dose of mifepristone, and 36-48 hours later misoprostol 600 mcg was given orally (400 mcg and, 2 hours later, 200 mcg). If the products of conception were not expelled within 4 hours, vaginal ultrasonography was performed. 8 patients aborted with mifepristone alone, 43 aborted after taking 600 mcg of misoprostol, and 5 more aborted after receiving a 2nd divided dose of 600 mcg misoprostol. In 3 patients the treatment failed, and they underwent evacuation of the uterus under general anaesthesia. Exploratory curettage was performed in 2 other patients at 14 and 22 days after treatment with misoprostol, but no products of conception were obtained. The median time from administration of misoprostol to abortion was 4 (1-11) hours. The median duration of bleeding after abortion was 10 (2-22) days. Side effects included nausea, vomiting (5 patients received antiemetic drugs), and diarrhoea (7 patients) from misoprostol treatment. 39 women did not want any pain relief, 13 asked for oral analgesia, and 7 obtained parenteral analgesia.
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PMID:Medical management of missed abortion and anembryonic pregnancy. 148 4

Mifepristone (RU 486) is a synthetic steroid with potent antiprogestational and antiglucocorticoid properties that offers an effective medical means of inducing abortion in early pregnancy. Since progesterone is essential for implantation, the authors tested the use of mifepristone for emergency postcoital contraception. 800 women and adolescents were studied who requested emergency postcoital contraception and who had had unprotected intercourse within the preceding 72 hours. A total of 398 women and adolescents were randomly assigned to treatment with 100 mcg of ethinyl estradiol and 1 mg of norgestrel, each given twice 12 hours apart (standard therapy) and 402 women and adolescents who were randomly assigned to receive 600 mg of mifepristone. None of the women or adolescents who received mifepristone became pregnant, as compared with 4 of those who received standard therapy; the difference in failure rates between the 2 regimens was not statistically significant. The number of pregnancies in each group was significantly lower than the number expected according to calculations based on the day of the cycle during which intercourse had taken place (p0.001). In many subjects, the stage of the cycle as calculated by menstrual history was inconsistent with measurements of plasma progesterone or urinary pregnanediol excretion. The subjects treated with mifepristone reported less nausea (40% vs. 60%) and vomiting (3% vs. 17%) on the day of treatment, as well as lower rates of other side effects, than those subjects treated with the standard regimen. However, they were more likely to have a delay in the onset of the next menstrual period (42% vs. 13%). Mifepristone is a highly effective postcoital contraceptive agent which, if more widely used, could help reduce the number of unplanned and unwanted pregnancies.
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PMID:Mifepristone (RU 486) compared with high-dose estrogen and progestogen for emergency postcoital contraception. 848 75

To identify risk factors for gastroschisis other than drug use in pregnancy, an analysis of data collected in a case-control surveillance program of birth defects (1976-1990) was conducted. Drug use is considered in Werler et al., Teratology, 45:361-367, 1992. Maternal demographic, reproductive, and medical factors, and first trimester environmental exposures, were compared between 76 gastroschisis cases and 2,581 malformed controls. A strong inverse association was found for maternal age: relative to women 30 years or older, relative risks for 25-29, 20-24, and less than 20-year-old women were 1.7, 5.4, and 16, respectively. Multivariate relative risks (and 95% confidence intervals) for alcohol use were as follows: for 1-5 drinks per week, 1.6 (0.7-3.4); for greater than or equal to 6 drinks per week, 2.5 (0.9-6.8); for a maximum of 1-4 drinks at any one time, 0.8 (0.4-1.6); and for a maximum of greater than or equal to 5 drinks, 2.8 (1.2-6.5). With the effect of age taken into account, no associations were identified for cigarette smoking, consumption of caffeinated or decaffeinated coffee, unplanned pregnancy, 12 or less years of education, or a parity of two or more. Other medical and reproductive factors, including weight gain, vaginal bleeding, nausea or vomiting, influenza, "other" infection, and history of spontaneous abortion or elective abortion did not increase the risk.
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PMID:Demographic, reproductive, medical, and environmental factors in relation to gastroschisis. 153 57

Outpatient terminations were performed on 100 ultrasonographically confirmed pregnancies of less than or equal to 63 days with a single oral dose of RU 38,486 (600 mg) and a single vaginal pessary of 16,16-dimethyl-trans-delta 2-prostaglandin E1 (1 mg) 48 hours later. Abortion occurred in all patients; in 95 it was complete, in four it was incomplete, and one resulted in a missed abortion. In 88% the abortion occurred within 4 hours of prostaglandin treatment. A total of 25% of patients had nausea and 15% vomited after RU 38,486 treatment. After prostaglandin-treatment, 13% vomited, 10% had diarrhea, and 23% required administration of an opiate analgesic agent. No patient was transfused and there was no genital tract trauma; one case of suspected pelvic infection occurred. If the need for termination arose again, 88% would elect to use the method again, 9% would not. The combination of the antiprogestin RU 38,486 and a vaginal prostaglandin pessary appears to offer a safe, efficient, acceptable nonsurgical outpatient method of termination. Further studies on dosage and treatment protocols would be justified.
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PMID:The efficacy of oral Mifepristone (RU 38,486) with a prostaglandin E1 analog vaginal pessary for the termination of early pregnancy: complications and patient acceptability. 168 61

60,000 women in France have received RU 486 and a prostaglandin to induce abortion. In the late 1980's, clinical researchers assessed the safety and effectiveness of 600 mg of oral RU 486 in 2040 French women. 2 days later, health workers either injected 0.25-0.5mg of sulprostone or inserted a 1mg vaginal suppository of gemeprost in 1964 women who had not yet aborted. 96% experienced complete abortions. Physicians needed to conduct either a vacuum aspiration of dilation and curettage on the other 4%. RU 486 was most successful with 0.5mg of sulprostone, but these women also experienced considerable vaginal bleeding and pain. Overall uterine bleeding occurred for 8.9 days. The researchers recommended that adequate medical facilities be accessible to women using this method. Mild side effects were nausea, vomiting, and diarrhea. Efficacy and safety matched those of other early abortion methods. In April 1991, a grand multiparous women who smoked heavily and received RU 486 and a prostaglandin died--the 1st reported RU 486 related death. RU 486 may be able to treat fibroids, endometriosis, premenstrual syndrome, meningioma, hypertension, adrenal cancer, glaucoma, some forms of Cushing's syndrome, and breast cancer. The US Food and Drug Administration forbade the commercial import of RU 486 in 1989, even though it deemed RU 486 safe and effective. FDA considered the antiabortion view of the Bush Administration when making this decision. It made this decision despite the fact that abortion was still legal. RU 486 should be available soon for use as an abortifacient in the UK, the Netherlands, Sweden, Norway, Denmark, and Finland. These countries do not intent providing it to US women, however. Further the manufacturer is not willing to provide it to US researchers because it is afraid of antiabortion repercussions which may jeopardize WHO's approval of RU 486.
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PMID:The RU 486 story: the French experience. 173 8

The development of the antiprogestin RU-486, and its current use in France and the UK, potential other application, politics in the US, and future are presented. Ru-486, as commonly known by its company code name, rather than its generic name mifepristone, is an analogue of a progestin used in oral contraceptives, with an added chemical group that allows it to link up with the progesterone receptor, but prevents progesterone's effects. It was approved in France in 1988, and has been used for early abortion up to 7 weeks LMP on 80,000 women. French women, after an initial diagnostic appointment, take 3 200 mg tablets of RU-486, then 36-48 hr later return for a Sulprostone (prostaglandin) injection, and are checked up 4-6 weeks later. About 96% abort completely. Some have nausea, vomiting, or pain. Bleeding averages 9 days, and 1% require treatment for bleeding. 2 cardiovascular events and 1 heart attack have been associated with the prostaglandin, now contraindicated in smokers or women 35. In England, RU-486 abortions began in late 1991, for pregnancies up to 9 weeks, using a gentler prostaglandin, Gemeprost, in a vaginal suppository. Only company-trained doctors may order the drug. Research continues on lower doses of RU-486, other prostaglandins, and effects on the fetus if abortion fails. While there is no known basis for a teratogenic effect of the antiprogestin, strong uterine contractions brought on by prostaglandins, such as misoprostol, as abused for illegal abortion in Latin America, may cause birth defects. RU-486 is expected to be useful for inducing labor, dilating the cervix, emergency contraception, pre-surgical management of Cushing's syndrome, brain cancers with profesterone receptors, among other conditions. Several of the 400 or so antiprogestins known are being tested clinically, notably HRP 2000 by WHO. Political controversy is so intense in the US that Roussel, the maker of RU-486, has no intention of marketing it, and even research supplies are unreliable. Meanwhile, pro-choice groups are innovating ways to test and market antiprogestins legally, perhaps inside state lines. It is expected that a suitable prostaglandin, misoprostol, licensed for peptic ulcer, will be available soon, and even RU-486 will become generic by 1998 when its patent expires.
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PMID:Antiprogestins and the abortion controversy: a progress report. 178 9

Researchers analyzed data on 80 pregnant women seeking a 2nd trimester abortion due to fetal abnormalities at the Federico II Medical School at the University of Naples in Italy to determine the effectiveness and side effects of 2 different prostaglandin analogues and their ability to bring about cervical ripening and uterine contractions. 40 women received 1 mg Gemeprost every 3 hours up to 5 mg in vaginal suppository form while the other 40 women who tended to be primigravidae received an intramuscular injection of 500 mcg Sulprostone every 4 hours up to 2000 mcg. Sulprostone achieved an 85% success rate and Gemeprost achieved an 82.5% success rate. Complete abortion occurred more quickly for multigravidae patients than it did for primigravidae patients (in hours, 10.6 vs. 16.5 for Gemeprost, p.1; 9.83 vs. 15.65 for Sulprostone, p.01). There was no statistically significant difference between the 2 treatment groups, however. Side effects were more common among Sulprostone patients than among Gemeprost patients (40% vs. 22.5%). The most common side effects among Sulprostone patients were, in descending order, abdominal pain (75%), diarrhea (50%), and nausea (50%). For Gemeprost patients, they were abdominal pain (55.5%) and headache (44.4%). In terms of uterine contractility, Sulprostone brought about hypertone more quickly than did Gemeprost (in minutes, 18.32 vs. 36.75; range 10-30 vs. 25-50). Gemeprost treatment was more like physiological labor than was Sulprostone treatment. Both prostaglandin analogues produced similar histological and ultrastructural findings of cervical ripening. These results indicated that the women were better able to tolerate Gemeprost.
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PMID:Uterine motility and cervical ripening in second trimester elective abortion by two different PGE analogues. 179 Jun 8

Oral contraceptive (OCs) which are highly effective, simple to use, and reversible, are used by 50 million women globally. In Germany 37.1% of women used them in 1985. Recently their acceptance has declined because of the fear of side effects such as cancer, thrombophlebitis, and frigidity. Other negative factors are opposition of partner, religious views, inconvenience of daily intake, negative reports from the press, discussion by family physician, and anxiety about complications in the offspring. Psychological and psychosomatic side effects very from 1% to 56%. Most are psychovegetative symptoms: headache, sweating, heart disorders, gastrointestinal tract (GI) disorders, nausea, and sleep disturbance. Psychological symptoms include increased irritability, impulsiveness, affective lability, anxiety, depressive feelings, reduced libido, and sexual disorders. Unconscious and ambivalent feelings about wanting a child and problems with the partner can result in forgetting to take the pill. Inhibitions, shame, guilt, and repressed feelings about sexuality lead to a sense of victimization in the form of pregnancy. The Catholic Church holds the view that contraception and abortion are unnatural as enunciated in a 1968 encyclical on human life. Conflicts with the partner can be resolved by compromise and by medical counseling of both parties. True psychopathological disorders have to be distinguished from the psychological problems of healthy people. The soundness of the physician-patient relationship is essential for contraceptive counseling and for resolving such conflicts.
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PMID:[Psychosomatic aspects of oral contraception]. 179 82

The results of evaluation of the contraceptive activity of the biphasic oral contraceptive anteovin are presented. 1 package of anteovin consists of 11 white tablets containing 0.05 mg of ethinyl estradiol and 0.05 mg of levonorgestrel and 10 pink tablets of 0.05 mg of ethinyl estradiol and 0.125 mg of levonorgestrel. Anteovin was tested according to the conventional 21-day regimen from day 5 of the cycle for 21 days, followed by 1 7-day rest period. Duration of anteovin administration ranged from 1 to 12 cycles. Anteovin was given to 160 women (aged 17 to 40 years old) who had a history of 618 pregnancies (182 ended by term delivery and 436 ended by induced abortion). During anteovin administration none of the women became pregnant. Side effects of anteovin included mild nausea during first several days in 12 women, breast tenderness in 4, and menstruation disorders in 8. The mechanism of contraceptive effect of anteovin was associated with ovulation inhibition. The changes in the basal temperature had a monophasic characteristic. Colpocytological examination showed decrease in the karyopyknotic and eosinophilic indices to 4-30%. All estrogen fractions (estrone, estradiol and estriol) in the urine showed statistically significant decrease on day 14-16 of the cycle (to 15.8 mcg/day, compared with 41.9 mcg/day in controls). The level of pregnanediol in the urine showed a decrease on day 20-23 of the cycle (0.66 mg/day, compared with 2.98 mg/day in controls). After 6 months of anteovin administration, there was a decrease in the basal and periovulation secretion of follicle-stimulating hormone, luteinizing hormone, and estradiol.
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PMID:[The clinico-pharmacological characteristics of anteovin]. 186 Apr 94

Health practitioners use many methods and agents to bring on cervical ripening in early pregnancy, such as intracervical tents and pharmacological techniques, to induce a therapeutic abortion. Prostaglandins alter myometrial and cervical tissue and are the most often used pharmacological technique. Reduced collagen concentration, an increase in water volume, an increase in prostaglandins (PGE2, PGI2, and PGF2 alpha), and a change in the glycosaminoglycan (GAG) content coincide with cervical ripening, yet the mechanism responsible for these changes is obscure. Prostaglandins appear to cause the breakdown of collagen or change the GAG/proteoglycan content. Research shows that prostaglandins can initiate cervical ripening at any stage of pregnancy. Estradiol stimulates prostaglandin production thereby al so inducing cervical dilation. Relaxin also demonstrates an ability to ripen the cervix. In addition, mifepristone (RU-486) is gaining acceptance as a cervical ripening agent. In fact, RU-486 and gemeprost have at least 95% success rate compared to 92% for gemeprost alone or 85% with RU-486 alone. The only effective and acceptable prostaglandins to use at gestation of 0-8 weeks are sulprostone, gemeprost, and 9-methylene-PGE2. At t his gestational age, pharmacological modulation is all that is needed. Even though they are effective (abortion rate 90%), side effects are expected to occur (pain, nausea, and vomiting). Similarly, prostaglandin analogues are preferable for cervical ripening in women at 8-12 weeks gestation. Suction curettage or other surgical techniques then are used to remove the conceptus. At 12-16 weeks gestation, many physicians prefer the same protocol as that of 8-12 weeks gestation. Other choose to infuse PGE2 and saline into the amniotic fluid to stimulate uterine contractions. Another procedure at 12-16 weeks involves 1mg vaginal pessaries of gemeprost every 3 hours to ripen the cervix and stimulate contractions. After 16 weeks, the methods for 12-16 weeks still apply.
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PMID:Pharmacological modulation of cervical compliance in the first and second trimesters of pregnancy. 187 72


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