Misoprostol treatment for early pregnancy loss: an international survey.

RESEARCH QUESTION: What is the global variability in misoprostol treatment for the management of early pregnancy loss (EPL)? DESIGN: An international web-based survey of fertility specialists and obstetrics and gynaecology clinicians was conducted between August and November 2020. The survey consisted of 16 questions addressing several aspects of misoprostol treatment for EPL. RESULTS: Overall, 309 clinicians from 80 countries participated in the survey, of whom 67.3% were fertility specialists. Nearly one-half (47.9%) of the respondents let the patient choose the first line of treatment (expectant management, misoprostol treatment or surgical aspiration) according to her own preference. The 248 respondents who administer misoprostol in their daily practice were asked further questions; 59.7% of them advise patients to take the medication at home. The most common dose and route of administration is 800 µg administered vaginally. Only 28.6% of participants use mifepristone pretreatment. Variation in the timing of the first follow-up visit after misoprostol administration was wide, ranging from 24 h to 1 week in most clinics. In case of incomplete expulsion, only 42.3% of the respondents routinely administer a second dose. The timing of the final visit and the definition of successful treatment also differed greatly among respondents. CONCLUSIONS: There is large variability in the use of misoprostol for the management of EPL. High-quality research is necessary to examine several aspects of the treatment. Particularly, the timing and effectiveness of a second dose administration and the criteria to decide on treatment failure or success deserve more research in the future.

Do we need a 200 µg misoprostol vaginal insert? A retrospective cohort study comparing the misoprostol vaginal insert to oral misoprostol.

AIM: The misoprostol vaginal insert (MVI) was reported to be more effective than dinoprostone but discussed critically because of high rates of fetal heart rate changes due to uterine tachysystole. The aim of this study was to investigate the outcome of induced labor using the MVI compared to off-label orally-administered misoprostol (OM). METHODS: Retrospective study including a total of 401 patients with singleton pregnancies in whom labor was induced at ≥36 0/7 gestational weeks with MVI (203) or OM (198). Primary outcomes were the time from induction to delivery, vaginal delivery in 24 h and the mode of delivery and the neonatal outcome. RESULTS: Median time until any delivery was 833 min (645-1278) for MVI and 1076.5 min (698-1686.3) for OM group; 83.7% of the patients in the MVI group gave birth within 24 h versus 63.6% in the OM group. The MVI group needed significantly less pre-delivery oxytocin (29%). Tachysystole (6.4%) and pathological CTG (30.5%) occurred at a significantly higher frequency in the MVI group. The cesarean section rate was significantly higher in the MVI group amounting to 21.7% versus 14.6% in the OM group (P < 0.05). Neonatal outcome did not differ between the groups. CONCLUSION: The MVI might be an option if you are in need for an approved and faster method to induce labor. Although we observed a significantly higher rate of fetal heart rate changes and cesarean sections in the MVI group this did not affect the neonatal outcome.

The misoprostol vaginal insert compared with oral misoprostol for labor induction in term pregnancies: a pair-matched case-control study.

AIM: To compare the efficacy and safety of the misoprostol vaginal insert (MVI) with an off-label use of oral misoprostol (OM). METHODS: Pair-matched case-control study comparing the induction of labor with a retrievable MVI to OM. The primary outcomes were the time from induction to delivery and the cesarean section rate. Secondary outcomes included uterine tachysystole, tocolysis, fetal scalp blood testing, meconium-stained amniotic fluid, umbilical arterial pH, and Apgar score. RESULTS: One hundred and thirty eight women ≥37/0 weeks pregnant undergoing labor induction with misoprostol were included. The mean time from application to delivery was significantly shorter and the caesarean section rate significantly higher in the MVI group (P<0.01) with an odds ratio of 2.75 (95% CI: 1.21-6.25) in favor of vaginal delivery in the OM group. The mean 5-min Apgar scores and arterial cord pH values were significantly lower in the MVI group. An arterial pH value of 7.10-7.19 was found in 26.1% and 15.9%, and a value <7.10 was found in 4.3% and 0% of MVI and OM cases, respectively. CONCLUSION: The MVI compared with OM significantly shortened the time from application to delivery at the expense of a higher cesarean section rate and negative effects on neonatal outcomes.

Labour Induction with Misoprostol in German Obstetric Clinics: What Are the Facts on Such Use?

Subject While the synthetic prostaglandin E1 analogue misoprostol is the most effect labour induction agent, its use is off-label for the most part. For this reason, and in view of its potential adverse effects and varying approaches to its administration, the drug has recently once again become a focus of critical attention. The objective of this survey was thus to establish a record of labour induction with misoprostol in German clinics and determine the impact of the negative reporting on everyday obstetric practice. Material and Methods In this cross-sectional study, 635 obstetrics and gynaecology departments in Germany were requested by email to participate in our survey in February/March 2020. Online responses to 19 questions were requested regarding the clinic, use of misoprostol before and after the critical reporting, use of misoprostol (sourcing, method of administration, dosage, monitoring) and other labour induction methods. Results A total of 262 (41.3%) of the clinics solicited for the survey completed the questionnaire. There were no differences regarding the care level (Perinatal Centre Level I, Perinatal Centre Level II, Clinic with Perinatal Focus or Obstetric/Private Clinic; p = 0.2104) or birth counts (p = 0.1845). In most cases, misoprostol was prepared in the clinic's own pharmacy (54%) or imported from another country (46%) and administered orally in tablet form (95%). Misoprostol dosage levels varied (25 µg [48%], 50 µg [83%], 75 µg [6%], 100 µg [47%] and > 100 µg [5%]). Most of the clinics used premanufactured tablets/capsules (59%), although Cytotec tablets were also divided (35%) or dissolved in water (5%). Misoprostol administration intervals were mainly every 4 hours (64%) or every 6 hours (30%). CTG checks were run in most cases before and after administration of a dose of misoprostol (78% and 76%) and before and after administration of a dose of prostaglandin E2 (both 88%). Presence of contractions led to no misoprostol (59%) or no prostaglandin E2 (64%) being administered in most cases. The critical reporting resulted in discontinuation of use of misoprostol in 17% of the clinics - mainly smaller obstetric/private clinics with fewer than 1000 births. Labour cocktails were used mainly in obstetric and private clinics (61%). Conclusion Misoprostol is an established agent for labour induction in German clinics. The dosing schemes used vary. Improvements of currently common management practices are required, especially in the area of labour induction (CTG checks before and after administration of labour-inducing medication, no administration of prostaglandin if contractions are ongoing). The discussion of use of misoprostol in the media resulted in stoppage of its use mainly in smaller clinics.

Outpatient Cervical Ripening With Misoprostol in Low-Risk Pregnancies.

Objective To determine if outpatient cervical ripening with daily misoprostol can reduce admission to delivery time in women with low-risk pregnancies at 39 or more weeks of gestation. Study design This is a retrospective cohort study of a convenience sample of low-risk pregnancies that underwent elective outpatient cervical ripening compared to matched controls for parity (nulliparous vs. parous) and gestational age. Time from admission to delivery, induction agents, presence of tachysystole, mode of delivery, length of hospitalization, neonatal intensive care unit (NICU) admission, and low Apgar scores were compared. Results Fifty-six patients who underwent outpatient cervical ripening with daily dosing of misoprostol were compared to 56 patients matched for parity and gestational weeks who underwent inpatient cervical ripening/induction of labor with misoprostol. We found the time from admission to delivery in the outpatient cervical ripening cohort was significantly lesser than the inpatient cohort (17.5 ± 11.5 hours outpatient vs. 26.6 ± 15.6 hours inpatient, P=0.001). More patients (N=18, 32%) were able to deliver within 12 hours of admission in the outpatient induction group compared to the inpatient group (N=8, 11%, P=0.010). There were no differences in frequency of cesarean delivery, uterine tachysystole with or without fetal heart rate changes, NICU admission, low Apgar scores, or low umbilical artery pH values between the two groups. Conclusion Outpatient cervical ripening with misoprostol may be a feasible alternative to inpatient cervical ripening in low-risk pregnancies, may help improve patient experience, and reduce the operational burden that elective induction confers upon labor and delivery units.

Comparison of sequential vaginal and sublingual misoprostol after a vaginal loading dose for second-trimester abortion.

OBJECTIVE: To evaluate the effects of sequential vaginal and sublingual misoprostol after a vaginal loading dose for second-trimester abortion. MATERIALS AND METHODS: From January 2006 to December 2011, 173 women received an 800-µg vaginal loading dose of misoprostol. After the loading dose, 103 patients received 800 mg of misoprostol vaginally and 70 patients received 400 mg of misoprostol sublingually every 12 h until the delivery of the fetus. RESULTS: In the vaginal group, the average abortion time was 1.07 ± 1.29 days; that was 0.82 ± 0.66 days in the sublingual group. Sequential sublingual misoprostol after a vaginal loading dose of 800 mg with an administration interval of 12 h had a similar abortion rate and time to abortion. In addition, this protocol reduced unnecessary digital pelvic examinations and speculum examinations. CONCLUSION: This sequential sublingual misoprostol regimen might be a suitable regimen for mid-trimester abortion.

Off-label use of misoprostol for labor induction in Germany: a national survey.

OBJECTIVE: Misoprostol is safe and effective for labor induction in viable pregnancies. Little is known about the prevalence of off-label use of misoprostol, and the reasons for using or not using misoprostol for labor induction. As such, a national survey was conducted in Germany to assess reliable data about the use of misoprostol in clinical practice. STUDY DESIGN: A prospective study was performed in 2013 using a standardized survey questionnaire. All registered departments of obstetrics and gynecology in Germany were targeted. RESULTS: Out of 783 questionnaires, 542 (69%) were returned. Three hundred and fifty-five (66%) respondents reported that they use misoprostol for labor induction in viable term pregnancies, and 183 (34%) respondents reported that they never use misoprostol for this indication. The most common reasons given for using misoprostol in labor induction were: effectiveness (40%), good patient acceptance (35%), established/well proven in clinical practice (35%) and cost-effectiveness (32%). The most common reasons given for not using misoprostol were lack of licence (off-label use, 69%) and uncertainty of the legal situation (27%). CONCLUSION: Although misoprostol is not licensed in Germany for obstetric indications, the vast majority of respondents (66%) reported that they use misoprostol for labor induction. The main reasons for not using misoprostol for labor induction in Germany are legal concerns rather than lack of scientific evidence. Cost-effective medications with evidence-based effectiveness and safety should be supported by a clear statement from national medical societies.

The freedom to birth-the use of cytotec to induce labor: a non-evidence-based intervention.

The off-label use of Cytotec (misoprostol) to induce labor has increased over the past few decades. The increase in medical interventions in childbirth, many of which are not based on scientific evidence, and the rise in maternal and infant morbidity and in maternal and infant mortality cannot continue to go unrecognized. This column serves as a teaching tool for childbirth educators and provides an example of two unnecessary, potentially avoidable deaths that occurred during a birth with questionable medical interventions.

Histórias de aborto provocado entre adolescentes em Teresina, Piauí, Brasil / Histories of induced abortion among adolescents from Teresina in the State of Piauí, Brazil

Este artigo analisa os métodos, os percursos e as redes de apoio utilizados por adolescentes para o aborto clandestino. O estudo, transversal e descritivo, entrevistou 30 adolescentes internadas após a curetagem uterina por aborto em dois hospitais públicos de Teresina, de junho a novembro de 2011. O consentimento livre e esclarecido foi oral e as entrevistas foram gravadas após a confirmação do aborto induzido. Majoritariamente, as adolescentes tinham entre 14 e 17 anos, eram solteiras, urbanas, moravam com os pais, tinham baixa escolaridade e registravam idade gestacional de 12 semanas. O Cytotec foi usado isoladamente por 28 (94%) adolescentes - de 3 a 6 comprimidos, vaginal e/ou oralmente, que procuraram o hospital após sangramento vaginal e/ou cólicas intensas. Elas compraram o Cytotec sozinhas (43%, 13) ou com ajuda de amigo ou companheiro (40%, 12), em farmácias comuns. O medicamento foi vendido pelo proprietário (45%, 13) ou pelo balconista (55%, 16), que deu as orientações de uso. O apoio para as adolescentes irem ao hospital foi dado pela mãe (40%, 12) ou por amiga (30%, 9). Houve 3 (10%) complicações graves, resultando em internação de até 20 dias. O estudo demonstra a predominância do Cytotec como método abortivo entre adolescentes.

This paper analyses the methods, techniques and support networks taken by adolescents to perform illegal abortions. It is a descriptive and cross-sectional study involving interviews with 30 adolescents who had been hospitalized for uterine curettage in two public hospitals in Teresina between June and November 2011. Informed consent was given orally, and the interviews were recorded after the confirmation of the induced abortion. The adolescents were between 14 and 17 years old, single, and predominantly lived with their parents in urban areas, had little schooling and recorded a gestational age of 12 weeks. Between 3 and 6 tablets of Cytotec were taken orally and/or vaginally by 28 (94%) adolescents, and they were rushed to the hospital due to severe cramping, vaginal bleeding or both. They either bought Cytotec alone (43%, 13), or with the help of a friend or partner (40%, 12). Cytotec was sold to them in ordinary pharmacies, by the owner (45%, 13) or clerk (55%, 55), who provided instructions for use. They went to the hospital with their mother (40%, 12) or a girl friend (30%, 9). Three (10%) adolescents developed serious complications. The study revealed that Cytotec is the main method used to perform illegal abortions among adolescents.

Cytotec e aborto: a polícia, os vendedores e as mulheres / Cytotec and abortion: the police, the vendors and women

Este artigo analisa o comércio ilegal do medicamento abortivo misoprostol no Brasil, com base no estudo de dez casos que alcançaram o Ministério Público do Distrito Federal e Territórios entre 2004 e 2010. Os dados foram assim organizados: 1. história das mulheres; 2. perfil dos vendedores; 3. casos de morte materna. Os resultados mostram que: 1. mulheres jovens, em relacionamento afetivo, fazem uso doméstico do misoprostol sozinhas ou com auxílio dos vendedores. Das sete mulheres indiciadas, três foram denunciadas ao chegar ao hospital público para finalização do aborto; 2. os vendedores são funcionários de farmácias e referências locais para o comércio do misoprostol. Eles informam as mulheres sobre uso do medicamento e prevenção de infecções, mas se recusam a socorrê-las em caso de emergência. Os traficantes atuam pela internet e possuem um estoque mais amplo de medicamentos; 3. houve duas mortes maternas por métodos invasivos combinados ao misoprostol. As principais causas de óbito são a demora em buscar auxílio médico por medo de denúncia policial e o uso combinado do misoprostol com métodos de alto risco.

This paper analyzes the illegal trade in misoprostol, the medication predominantly used for abortion in Brazil. The study analyzed ten cases that came to the attention of the Public Prosecution Service for the Federal District between 2004 and 2010. The cases were organized into three categories: 1. women's stories; 2. profile of the vendors; 3. maternal mortality cases. The research was reviewed by an ethics committee. The main outcomes were: 1. young women in steady relationships use misoprostol in the home or with the assistance of drug vendors. Of the seven women indicted, three were reported on arrival at the public hospital to finalize abortion; 2. the drug vendors work at the community drugstore and are local agents for the sale of misoprostol. They instruct women on how to use the drug and how to prevent infections, but refuse to provide them with care in case of emergency. Traffickers operate via the internet and have a larger inventory of drugs; 3. there were two cases of maternal mortality due to the combination of high risk methods, such as a vaginal probe and misoprostol. The main causes for maternal mortality are the delay in seeking medical care, as the women fear criminal prosecution, and the combined use of misoprostol with high risk methods.

Itinerários e métodos do aborto ilegal em cinco capitais brasileiras / Itineraries and methods of illegal abortion in five Brazilian state capitals

O artigo apresenta os resultados da etapa de entrevistas estruturadas da Pesquisa Nacional de Aborto (PNA-entrevistas), descrevendo características das mulheres que fizeram ao menos um aborto ilegal, os itinerários e os métodos. Entrevistas estruturadas feitas em 2010 e 2011 com 122 mulheres entre 18 e 39 anos que abortaram, em cinco capitais brasileiras (Belém, Brasília, Porto Alegre, Rio de Janeiro e Salvador). Amostra não probabilística controlada por seis cotas, de acordo com nível educacional e idade, refletindo a estrutura social e demográfica encontrada na PNA-urna. A maioria das mulheres entrevistadas realizou apenas um aborto, mas uma em cada quatro realizou dois abortos, e uma em cada 17 realizou três abortos. A maioria dos abortos ocorre entre jovens até 19 anos, muitas das quais já tiveram filhos. Os exames mais comuns para identificar a gravidez são o beta-HCG sérico, o teste de urina de farmácia e o ultrassom. Há uma prevalência do aborto entre mulheres negras. O principal método abortivo é uma combinação de chás e cytotec (misoprostol) com a finalização em hospitais. Parentes e companheiros auxiliam em diferentes etapas do processo. Várias mulheres relataram já ter ajudado outras mulheres a abortar após sua experiência individual.

This paper presents the results of the structured interview phase of the National Abortion Survey (PNA-interviews), describing the itineraries, methods and social and demographic profile of women who had at least one illegal abortion. Structured interviews were conducted during the years 2010 and 2011 in five state capitals (Belem, Brasilia, Porto Alegre, Rio de Janeiro and Salvador) with 122 women aged between 18 and 39 who had abortions. It is a non-probabilistic sample controlled by six parameters in accordance with level of education and age to reflect the social and demographic structure found in the PNA ballot-box questionnaire phase. The majority of women interviewed had had only one abortion, but 1 in every 4 had two abortions and 1 in every 17 had a third one. The majority of abortions are among women under 19 years of age who already had children and a higher incidence is found among black women. The most common test for pregnancy is beta-HCG blood test, the pharmacy urine test and ultrassound. The prevailing method for induction is a combination of teas and misoprostol (called Cytotec in Brazil), followed by hospital assistance after induction. Women are usually helped by a relative or their partners and several women reported helping other women to have abortions.

"Levante a mão aqui quem nunca tirou criança!": revisitando dados etnográficos sobre a disseminação de práticas abortivas em populações de baixa-renda no Brasil / "Those of you who have never had an abortion, raise your hand!": rethinking ethnographic data on the dissemination of abortion practices among low-income populations in Brazil

A partir de dados quantitativos sobre a magnitude do aborto em pesquisas recentemente publicadas, este artigo retoma dados etnográficos a respeito da pratica do aborto com o objetivo de estabelecer uma discussão sobre sua disseminação, suas possíveis configurações culturais e sua legitimidade social no contexto de populações urbanas de baixa-renda no Brasil. O presente trabalho refere retrospectivamente a duas diferentes pesquisas empíricas e aponta uma estimativa sobre prevalência de aborto em torno de 34%; apresenta dados descritivos e os significados sociais tecidos em torno desta prática. Os estudos aqui apresentados buscam contribuir para o entendimento da tomada de decisão da mulher no que tange esta opção reprodutiva em um contexto onde o aborto é ilegal. O principal resultado destas pesquisas é apontar para uma fluidez de significados a respeito da interrupção da gravidez, o que permite construir uma tipologia que classifica os abortos, na perspectiva da população estudada, em toleráveis, condenáveis e recomendáveis. Através dos dados apresentados é possível inferir o quanto a dimensão do problema - tanto no que diz respeito ao numero de casos quanto à realidade das práticas abortivas e métodos - pouco mudou em um período de 20 anos no Brasil.

Based on recently published research findings on abortion rates, this paper re-examines original ethnographic data on abortion in order to open a discussion on the dissemination of abortion, its possible cultural configurations and its social legitimacy among low-income populations in Brazil. It refers retrospectively to two works of empirical research studies and presents an estimate of the prevalence of abortion of around of 34%; it describes abortion practices and the social representation of what abortion means in a given context. The studies presented here seek to contribute to the understanding of women's decision-making regarding this reproductive choice in a context where abortion is illegal. The data allow us to construct an abortion typology, classifying it as tolerated, unacceptable and recommended and point to a fluidity of meanings regarding pregnancy interruption practices. It is possible to infer that the magnitude of the problem of abortion, both with regard to number of cases and the existing diversity of abortion practices and methods, has not changed over a period of 20 years in Brazil.

Misoprostol and teratogenesis in neonates / Misoprostol e teratogênese em neonatos

This paper is focused in some aspects of maternal exposure to misoprostol during perinatal period, and the abortive and teratogenesis effects on the fetus. The causes of malformations were revised, taking into account chemical, physical and environmental factors as well as the interaction between them. There are evidences that the practice of abortion tripled in Southern and Northeastern Brazil in 15 years, and one of the most frequent forms of abortion is through the use of misoprostol. In Brazil, 1991, 288,700 women were hospitalized as a consequence of complications induced by abortion attempt with this medicine. This fact resulted in the ban of misoprostol across our country, by Decree 344/98 determined by the Health Ministry. The use of misoprostol requires special control and it is allowed only in hospitals, with supervision of the municipal health surveillance. Among the more severe problems affecting the non-aborted child is the injury on the central nervous system, which frequently results in the Moebius syndrome. This is a congenital and non-progressive paralysis of the VI and VII cranial nerves, frequently bilateral, which produces a unexpressive facial appearance and convergent Strabismus. Even banned in our country, abortion is illegally practiced, being deprived of proper knowledge about misoprostol teratogenic effects on the fetus as well as the risks involving mothers.

Este trabalho enfoca aspectos relativos à exposição ao misoprostol no período perinatal como abortificante e agente teratogênico, assim como as causas das malformações, considerando-se fatores químicos, físicos e ambientais. A prática do aborto triplicou nas regiões Sul e Nordeste em 15 anos, sendo que entre os métodos mais freqüentes está o uso do medicamento com o princípio ativo do misoprostol. Em 1991 no Brasil, 288.700 mulheres foram socorridas em hospitais devido a complicações por indução de aborto com este medicamento. Isso resultou na proibição do misoprostol em todo país por determinação da portaria 344/98 do Ministério da Saúde, que exige um controle especial, onde sua utilização é permitida apenas em hospitais e com supervisão da vigilância sanitária municipal. Um dos problemas mais graves que a criança não abortada apresenta é uma injúria em seu sistema nervoso central desenvolvendo a Síndrome de Moebius. Esta é uma paralisia congênita e não progressiva do VI e do VII nervos cranianos, freqüentemente bilateral, que produz uma aparência facial pouco expressiva e estrabismo divergente. Neste sentido, mesmo sendo proibido em nosso país, o aborto induzido por misoprostol é praticado ilegalmente e sem uma verdadeira instrução da paciente sobre os efeitos teratogênicos do mesmo para ela e para seu bebê.