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Denial of pregnancy is a rare psychic process associated with an increased risk of infant death. Forensic examinations to determine viability at birth can heavily influence the legal proceedings in cases of clandestine deliveries that result in the death of the infant. A 32-year-old woman who experienced a denial of pregnancy up to 30 weeks of amenorrhea reported giving birth at home at an estimated term of 35 weeks of amenorrhea. No one witnessed the delivery. She claimed the infant was stillborn. Forensic examinations revealed characteristic features of a live born infant. The mother tested positive for mifepristone. Mifepristone is an anti-progestin drug used for early abortion and to induce labor in cases of in-utero fetal death in later pregnancy. Even if mifepristone crosses the placenta, it has no direct toxic effect on the fetus. Our observations suggest premature live birth caused by mifepristone, followed by asphyxia due to meconium inhalation syndrome associated with lung immaturity especially since the birth occurred at home and no medical care was provided after the birth. The tragic outcome of this clinical case calls for vigilance and global management, including the psychiatric care of parturients in the context of late discovery of pregnancy. In France, this situation showed a legal gap between the consideration of the fetus and laws concerning abortion. To our knowledge, in France, this case has allowed the court to set a legal precedent as a similar case had never been reported elsewhere. [ABSTRACT FROM AUTHOR]

Introduction: Women frequently report pain associated with medical termination of pregnancy (MToP), and its management can differ largely between centres. This study aimed at evaluating in real-life settings pain related to MToP and its management in France. Methods: This was a non-interventional prospective, longitudinal study run in 23 centres between 2015 and 2016 that included 893 pregnant women. Pain was reported by women prior any curative analgesic intake (CAI) through a five-level Likert scale (absence, mild, moderated, severe, extreme). Modalities of analgesic prophylaxis prescription (APP) and intake (API) and CAI were collected. Risk factors were investigated using ordinal logistic regression (for pain) or logistic regression (for CAI) with stepwise selection of variables. Results: APP was prescribed to 657 (73.7%) women irrespective of the gestational age, among whom 386 (73.7%) took the treatment. Out of 740 women who documented their pain symptoms prior to any CAI, few declared no pain (n = 94, 12.7%) or intense pain (n = 88, 11.9%). The majority reported mild or moderate pain (n = 558, 75.4%). On multivariate analysis adjusted on gestational age, increasing initial [odds ratio (OR) 1.25, 95% confidence interval (CI) 1.06–1.47] or total dose (OR 1.15, 95% CI 1.05–1.26) of misoprostol taken were independent factors associated with risk of more pain. When adjusting for gestational age, initial dose of misoprostol (OR 1.69, 95% CI 1.45–2.66) and pain experienced (OR 3.58, 95% CI 2.82–4.55) were significantly associated with higher risk of CAI while API (OR 0.52, 95% CI 0.36; 0.75) was negatively associated. Conclusions: Most of the women received an APP, but not all used it. API and gestational age were not related to different risks of more pain following MToP, whereas history of at least one child showed a negative association. Higher doses of misoprostol were strongly associated with both pain and CAI. API was associated with a decreased risk of CAI. [ABSTRACT FROM AUTHOR]

The clinical use of mifepristone for medical abortions has been established in 1987 in France and since 2000 in the United States. Mifepristone has a limited medical period that lasts <9 weeks of gestation, and the incidence of mifepristone treatment failure increases with gestation time. Mifepristone functions as an antagonist for progesterone and glucocorticoid receptors. Studies have confirmed that mifepristone treatments can directly contribute to endometrium disability by interfering with the endometrial receptivity of the embryo, thus causing decidual endometrial degeneration. However, whether mifepristone efficacy directly affects embryo survival and growth is still an open question. Some women choose to continue their pregnancy after mifepristone treatment fails, and some women express regret and seek medically unapproved mifepristone antagonization with high doses of progesterone. These unapproved treatments raise the potential risk of embryonic fatality and developmental anomalies. Accordingly, in the present study, we collected mouse blastocysts ex vivo and treated implanted blastocysts with mifepristone for 24 h. The embryos were further cultured to day 8 in vitro to finish their growth in the early somite stage, and the embryos were then collected for RNA sequencing (control n = 3, mifepristone n = 3). When we performed a gene set enrichment analysis, our data indicated that mifepristone treatment considerably altered the cellular pathways of embryos in terms of viability, proliferation, and development. The data indicated that mifepristone was involved in hallmark gene sets of protein secretion, mTORC1, fatty acid metabolism, IL-2-STAT5 signaling, adipogenesis, peroxisome, glycolysis, E2F targets, and heme metabolism. The data further revealed that mifepristone interfered with normal embryonic development. In sum, our data suggest that continuing a pregnancy after mifepristone treatment fails is inappropriate and infeasible. The results of our study reveal a high risk of fetus fatality and developmental problems when pregnancies are continued after mifepristone treatment fails. [ABSTRACT FROM AUTHOR]

In 1988, French pharmaceutical company Roussel Uclaf introduced Mifepristone (RU 486), a pill which medically induces abortion, but withdrew the drug one month later after severe protests. The abortion pill caused transnational controversies from 1988 to 1993. This article examines these controversies as a gateway to the entanglements between biomedical research, economic interests, and social protests in the last third of the twentieth century, as the American antiabortion movement initiated protests against the drug's French producer and its German parent company after its market release in France. The movement used boycotts against French products and utilized discomforting references to Germany's Nazi past to put pressure on pharmaceutical executives. In contrast, German, French, and American feminists and family-planners relied on transnational networks to enable medical trials and ensure the global distribution of Mifepristone. The article highlights how feminist demands for individual choice and public health concerns clashed with the antiabortion movements' demands and entrepreneurs' concerns about crude Holocaust comparisons. It shows that actors on both sides of the abortion controversy employed nonmedical arguments to influence scientific research and social movements acted on a transnational level to influence the market introduction of new biomedical advances. [ABSTRACT FROM AUTHOR]

Objective: To assess, in real-life conditions, the success rate of the protocol mifepristone 600 mg / prostaglandin analogue (PG) in women requesting medical termination of pregnancy (MToP) either up to or beyond 7 weeks of amenorrhea (WA).Study Design: The study was performed between 2015 and 2016. This was a non-interventional prospective, multicentre, longitudinal study conducted in France, among a sample of public and/or private centres dealing with MToP. Characteristics of women, term of Mtop, modality of PG used were reported. The primary outcome was success of MToP, defined as complete abortion without surgical procedure.Results: A total of 893 pregnant women with less than the legal term of 14 WA were included in this study: 490 (54.9 %) ≤7 WA and 403 (45.1 %) >7 WA comprising 29 > 9 WA. The mean age of women was 28.1 ± 6.8 years and the one of pregnancy was 7.0 WA ± 1.3 WA. The most frequently used PG combined to mifepristone 600 mg was misoprostol 400 μg (57.0 % ≤7 WA and 35.1 % >7 WA) or 800 μg per os (oral or oral transmucosal) (27.5 % ≤7 WA and 40.1 % >7 WA). Vaginal misoprostol (6.4 %, N = 48) and gemeprost (5.2 %, N = 39) were less used. In women ≤7 WA (N = 422) and women >7 WA (N = 354) for whom result of the MToP was collected, success rates were 94.5 % (95 %CI 91.9 %-96.5 %) and 92.4 % (95 %CI 89.1 %-94.9 %), respectively (p = 0.219). In multivariate regression analysis, three factors were significantly associated with a higher risk of MToP failure: increased number of previous pregnancies (OR = 1.233; 95 %CI 1.086-1.401 for one pregnancy), increased number of previous surgical ToPs (OR = 1.563; 95 %CI 1.036-2.359 for one ToP) and increased interval between mifepristone and PG intake (OR = 1.061; 95 %CI 1.012-1.112 for one hour). Term of pregnancy (OR = 1.497; 95 %CI 0.833-2.690 for ≤7 WA vs >7WA), administration route (OR = 1.553; 95 %CI 0.488-4.936 for oral vs oral transmucosal; and OR = 1.216; 95 %CI 0.625-2.366 for vaginal vs oral transmucosal), and dose of misoprostol (OR = 1.000; 95 %CI 0.999-1.001), were not associated with the risk of failure. Overall, tolerance was good.Conclusion: This study showed, in real-life settings, a high rate of success for MToP using mifepristone 600 mg, independent of the pregnancy term and the therapeutic protocol used. MToP was safe and well tolerated however only a small number of women beyond 9 WA have been included. [ABSTRACT FROM AUTHOR]

Objective: To compare the level of pain reported by women by dose of mifepristone, 200 or 600mg, and describe the main factors related to the pain level in the 5 days after a medical abortion.Study Design: Observational study in 11 medical centers in France between October 2013 and September 2014. The protocols were 200 or 600mg orally mifepristone on day 1 of the medical abortion and 400, 600 or 800μg orally misoprostol on day 3. Women returned a questionnaire that they completed during 5 days following the abortion; pain was recorded on a visual analog scale (0-10) daily.Results: 453 women were included; the mean age was 29 years (range 18-49 years). Pain was greater with 200 than 600mg mifepristone: 33% of women reported a pain level of ≥8 on day 3 with 200mg as compared with 16% with 600mg. This difference remained after controlling for age, gestational age, gravidity, usual painful menstruation and misoprostol dose. Percentages of symptoms as vomiting or diarrhea were also lower with 600mg mifépristone than 200mg.Conclusion: The mean pain severity experienced by women undergoing medical abortion is high; it is higher with a regimen of 200mg mifepristone. The findings emphasize the need to improve analgesic strategies and invite to opt for a protocol of 600mg instead of 200mg mifepristone. [ABSTRACT FROM AUTHOR]

Objectives Medical termination of pregnancy (MToP) has become more frequently used, and specific recommendations have been issued by the French Authorities regarding protocols. The aim of this prospective, multicenter, longitudinal observational study was to record actual practices and to describe efficacy and safety of drugs used for MToP in real-life conditions in France. Study design The study was performed between 2011 and 2012 in a representative sample of 47 centers dealing with abortions. Pregnant women with less than 14 weeks of amenorrhea, requesting MToP, for whom a drug regimen including mifepristone was decided, were recruited and information was recorded from the center and through the patient's auto questionnaire. The main efficacy parameter was complete abortion without surgical procedure. Results A total of 1585 women (mean age: 27.6 ± 6.8 years) were included by 47 centers. At inclusion time, when women were given mifepristone, the mean term of pregnancy was 46.5 ± 7.8 days of amenorrhea (DA), the term was >49 DA for 28.3% of patients, and >63 DA for 1.6%. The most frequently used protocol was the one recommended by the French authorities (mifepristone 600 mg-misoprostol 400 μg oral), used in 35.4% of patients, but other protocols were used (mifepristone 600 mg or 200 mg in association with misoprostol 2 × 400 μg per os , for respectively 23.4% and 13.5%). Gemeprost prostaglandin was used by 1.4% of patients only. Of the patients, 10.3% did not return to the center and were considered as lost to follow up. For the 1421 patients for whom information was available, the successful abortion rate was 94.4%. In the remaining 5.6% there were no ongoing pregnancies, but their condition required a secondary surgical procedure. Over 90% of the 1421 patients with follow-up were satisfied with the procedure. Safety was good, with only 16 cases of major bleeding(1%), and one of endometritis (0.1%) reported as serious adverse events. Conclusion Our study showed, in real-life settings, a high rate of success for MToP. Whatever the protocol used, this approach is effective, well tolerated, and satisfactory for the majority of patients. [ABSTRACT FROM AUTHOR]

Abstract: Introduction: Medical abortion is one of the most important advances of the last century in the field of reproductive health. However, the introduction and use of the technology varies widely among countries. Study design: The article examines the commercial, political, regulatory, and legislative history of the introduction of mifepristone-misoprostol in France and the United States. Results: While the introduction of the technology has been deemed a “success” in each country, existing patterns of medical research, abortion service provision and health care financing came to alter the uptake and use of medical abortion in the two countries. Conclusion: Proof of safety, efficacy and patient acceptability are in themselves not enough to assure successful introduction and widespread use of medical innovations. However, the case studies illustrate that there is more than one way to arrive at expansion of new technologies. [Copyright &y& Elsevier]

Provision of safe abortion to the full extent of the law is an important component of reproductive health services. The development of methods for the termination of early pregnancy medically (nonsurgically) has created alternative options to make abortion available to women in a variety of healthcare settings. Since the first approval in France in 1988, the regimen of mifepristone followed by a suitable prostaglandin analog has been licensed in over 30 countries and, in many of them, up to 50% of all early abortions are now induced with the regimen. This experience suggests that medical abortion is acceptable to women and safe when provided under proper conditions. Mifepristone is the first and, until now, the only antiprogestin that has been available for medical abortion, while misoprostol has replaced the prostaglandins that were used when the medical abortion regimen was first developed. Further research has focused on improving efficacy, simplifying the regimen and defining the optimal dose and route of administration of misoprostol. In many countries, however, the results from research have not been taken into account at the time the regimen was licensed and this often causes confusion among providers. [ABSTRACT FROM AUTHOR]

Objective To test the feasibility, safety, and efficacy of home use of two doses of misoprostol for medical abortion (MA) in European settings. Methods One hundred thirty women (100 in Sweden, 30 in France) presenting for first-trimester MA were administered oral mifepristone in the clinic and sent home with two 400 μg doses of misoprostol, along with instructions to take the misoprostol at 24 h intervals. Women were also asked to complete a daily symptom diary. Outcomes of interest included effectiveness, side-effects, and adherence to and acceptability of the home-use regimen. Results Three women (all in France) were lost to follow-up. Of the remaining 127 women, 124 (98%) had a successful MA. All women adhered successfully to the home-use regimen, and satisfaction with home use was high (98%). Most women experienced noticeable, if transitory, side effects after both the first and second doses of misoprostol (97% and 94%, respectively). Conclusions Misoprostol may successfully and satisfactorily be used at home as part of a MA regimen in European settings as it has been for years in the US. Further research to determine if two doses of misoprostol are more effective than a single dose would be useful. [ABSTRACT FROM AUTHOR]

The article presents a study reporting preference of medical abortion with the drug mifepristone over surgical abortion, by French women seeking early abortions and their level of satisfaction. The study population consisted of patients at six French abortion centers in 1990. Of the original 488 women, 62% intended to use mifepristone. Those choosing medical abortion and those who chose local anesthesia were more likely to have had some form of education beyond secondary or primary school than were women who chose general anesthesia and women with no intended choice of method. Of those women who chose a medical abortion, 93% had a Western cultural background. The most frequently mentioned reasons for choosing any method were that it seemed less traumatic, less dangerous, safer for future pregnancies or less likely to fail. Only 5% of women who chose mefipristone did so because of its low failure rate, compared with 39% of the women who chose surgical abortion with local anesthesia and 33% of the women who chose general anesthesia.

The article presents a discussion on clinical trials of the antiprogestin mifepristone (RU 486) drug in France. Abortion can be induced without surgery at least 96 percent of the time when the RU 486 drug is given, along with a prostaglandin, to women pregnant for less than seven weeks, according to the results of a large-scale French trial. The pregnancies of women who took the largest dose of prostaglandin were terminated almost 99 percent of the time, substantially more quickly than those of women who took smaller doses of the prostaglandin. However, women who used the larger dose also experienced substantially more pain during the abortion and bled longer afterwards than did those who used the smaller dose. In September 1988, the French government approved the marketing of mifepristone as an abortifacient. The drug can be used only during the first seven weeks of amenorrhea, and only along with a prostaglandin. The two-stage medical treatment, which involves taking RU 486 first and the prostaglandin several days later, became available to French women early in 1989. Since then, more than 40000 women have taken mifepristone in order to obtain an abortion without having surgery.

The article reports that the antiprogestin drug mifepristone can be used to induce labor in a vaginal delivery, even when the woman has had a previous cesarean section. At a hospital in France, researchers identified 32 women at or near term who for a variety of medical reasons were scheduled to have labor induced. Eleven of the 16 women treated with mifepristone began labor within the study period, compared with two of those given the placebo. Among the remaining women, those treated with mifepristone needed half as much oxytocin to initiate labor as did those given the placebo, and had a shorter mean time between treatment and the start of labor.

Reports on the development of the progesterone antagonist RU-486 (mifepristone), a synthetic antiprogestin that works by competitive inhibition at the receptor level in both the endometrium and trophoblast. Induction of complete abortion in women when administered with a subtherapeutic dose of prostaglandins; Campaigns that prevent commercial distribution of RU-486.

Unlabelled: In 1989 the French Ministry of Health gave its agreement to the utilisation of the combination mifepristone + a prostaglandin analogue for abortion up to 49 DA. Since then, research activities have been carried out to improve this method. Research to define the best prostaglandin analogue: sulprostone and gemeprost were dropped out; misoprostol was authorized in 1992 following very convincing trials, it is now commonly used and has never generated any major problem. Research to extend the application time limit to 63 DA: it showed a significant drop in efficiency (86.8% instead of 95.4%) as well as an increase of the rate of haemorrhages (2.25% instead of 0.3%). Therefore the method currently used reads as follows. Day 1: mifepristone 600 mg, day 3: misoprostol 400 micrograms, day 10-15: control visit. The efficiency rate is 95.4%; an additional dose of 400 micrograms of misoprostol 3 hours after the first dose if no expulsion has occurred, increases the rate up to 98.5%. This method is well accepted by women as it enables an early abortion and avoids surgery and anesthies. The arrangements required to implement the method are not easy to make as they call for a change of habits by the institutions as well as by medical teams., Conclusion: Since the use of misoprostol, the abortion by mifepristone using. 400 micrograms + 400 micrograms of misoprostol has become a method which is safe, efficient and much appreciated by women, but it implies a change in the usual practice of abortion.

In France, pregnant women with amenorrhoea of no more than 49 days intending to terminate pregnancy can choose between a surgical abortion via vacuum aspiration under local or general anesthesia and a drug method combining Mifepristone orally administered (RU 486 degrees), with a prostaglandin analogue. This prospective survey was conducted to study the conditions under which women choose their abortion method, and to evaluate the acceptability of each method after the abortion. The data gathered from 488 women were analyzed according to their initial decision, and then according to the method actually used. The majority (62%) chose RU 486. The women's choice was found to be linked to sociodemographic characteristics such as age, education, occupation, geographic origin, and certain attitudes towards pregnancy, as well as to the individual criteria of each method. The women who chose the drug protocol had most often already made their decision before going to the family planning center (68%), having been advised by their doctor (20%). They were slightly less satisfied with the abortion experience than they had expected: 12.4% were unsatisfied in the RU group and 3.6% in the aspiration group. They needed more rest and quiet afterwards (50%) than the other women. They were distinguished by their desire to verify the expulsion (63%). The length of pregnancy is therefore not the only criterion to be considered when recommending one or other of these methods: the women concerned have different requirements and should have several possibilities to choose from.

We report the results of a large-scale trial with mifepristone (RU 486) followed by the administration of a prostaglandin (PG) analogue for the medical termination of early pregnancy. Altogether, 16,173 patients from 300 centers were evaluated. 48 women (0.3%) were lost to follow-up prior to, and 416 (2.6%) after the PG administration, and therefore the efficacy was evaluated in 15,709 women. Overall, the success rate was 95.3%, with no statistical difference regarding the nature and dose of PG used. The median duration of bleeding was 8 days, being 12 days or less in 89.7% of the women. Bleeding was significant enough to necessitate a vacuum aspiration or a dilatation and curettage in 0.8% of the cases. A blood transfusion was necessary in 0.1% of the women (11 patients). Serious cardio-vascular side-effects were reported in 4 cases after the PG (sulprostone) injection: they consisted of one acute myocardial infarction attributed to a coronary spasm, and in marked hypotension in the other 3 women. All patients recovered uneventfully. In conclusion, RU 486 followed by a PG analogue provides an efficient and safe medical alternative to surgery for early pregnancy termination, provided that the recommended protocol is adequately followed and the contraindications to prostaglandins are respected.

Today we are faced with a new abortion method: until the 49th day of pregnancy a pregnant woman will loose her child as a consequence of an artificial miscarriage by taking the hormone drug RU 486. It opens a new perspective as a new contraceptive method, an abortion method and a new possibility for family planning in Third World Countries. This pill has been developed and produced by the French chemical company Roussel-Uclaf and is available in France, Great Britain and China. Permission to operate on the German market hinges on 3 conditions: that there is new abortion legislation in Germany, the exclusion of misuse is guaranteed and a representative group requires the application.

Mifepristone (Mifegyne 200 mg) is a newly approved drug in France for termination of early pregnancy. Consequently, doctors and pharmacists have to follow strict legal rules of prescription, administration, storage, and dispensing. French requirements are reviewed with particular regard to practical procedures of dispensing.

Are reported the results obtained with mifepristone, administered alone or followed by a low dose of prostaglandin derivative, as an alternative to endometrial aspiration for termination of early pregnancy. Mifepristone was first used alone in doses of 600 mg in 1,841 women. Subsequently, 703 other women received, 36 to 48 hours after mifepristone, either sulprostone (a prostaglandin E2 analogue) 0.25 mg intramuscularly, or gemeprost (a prostaglandin E1 analogue) 1 mg as pessary, or meteneprost (a prostaglandin E2 analogue) 10 mg as pessary. Mifepristone administered alone was successful in 80 per cent of pregnant women with less than 42 days of amenorrhoea. The mifepristone-prostaglandin combination was successful in more than 95 per cent of pregnant women with less than 50 days of amenorrhoea. Expulsion of the ovum was difficult to date when mifepristone was used alone; it occurred within 24 hours of prostaglandin dosing in more than 80 per cent of the other women. Uterine bleeding was almost constant. It was more copious than the usual menses in the majority of women, with or without prostaglandin, and it sometimes required aspiration or curettage (mifepristone alone 1.3 per cent, with prostaglandin 0.28 per cent) and/or blood transfusion (mifepristone alone 0.4 per cent, with prostaglandin 0.14 per cent). Administered alone, mifepristone was very well tolerated. When prostaglandin analogues were added the women complained of lower abdominal pain which required a minor antalgic treatment in 30 to 50 per cent of the cases. Gastrointestinal side-effects were mild, probably due to the low doses of prostaglandin administered.