Landscape assessment of the availability of medical abortion medicines in India.

BACKGROUND: Medical abortion with mifepristone and misoprostol can be provided up to 63 days' gestation in India. This accounts for 67.5 percent of all abortions in the country. We conducted an assessment to determine the availability of medical abortion medicines, specifically the combi-pack, in India. METHODS: We applied the World Health Organization landscape assessment protocol at the national level. The assessment protocol included a five-step adaptation of an existing availability framework, including online data collection, desk review, country-level key informant interviews, and an analysis to identify barriers and opportunities to improve medical abortion availability. The assessment was conducted between August and March 2021. RESULTS: Medicines for medical abortion are included in the national essential drug list and available with prescription in India. The assessment identified 42 combi-pack products developed by 35 manufacturers. The quality of medical abortion medicines is regulated by national authorities; but as health is devolved to states, there are significant inter-state variations. This is seen across financing, procurement, manufacturing, and monitoring mechanisms for quality assurance of medical abortion medicines prior to distribution. There is a need to strengthen supply chain systems, ensure consistent availability of trained providers and build community awareness on use of medical abortion medicines for early abortions, at the time of the assessment. CONCLUSION: Opportunities to improve availability and quality of medical abortion medicines exist. For example, uniform implementation of regulatory standards, greater emphasis on quality-assurance during manufacturing, and standardizing of procurement and supply chain systems across states. Regular in-service training of providers on medical abortion is required. Finally, innovations in evidence dissemination and community engagement about the recently amended abortion law are needed.

Medical abortion is popular in India and benefits from a liberal legal context. It is important to understand the availability of quality abortion medicines in the country. Using the World Health Organization country assessment protocol and availability framework for medical abortion medicines we examined the availability of these medicines from supply to demand. We used this information to identify opportunities for increasing availability of quality-assured medical abortion medicines. We found that the context for medical abortion varies across states. Strengthening procurement and supply chain management, with a greater emphasis on quality-assurance and regulation of manufacturing should be instituted at the state-level. Training is also needed to increase provider knowledge of the latest national guidelines and laws to ensure respectful and person-centered services. Finally, the public should be informed about medical abortion as a safe and effective choice, especially for early abortions.

Access to mifepristone, misoprostol, and contraceptive medicines in eight countries in the Eastern Mediterranean Region: descriptive analyses of country-level assessments.

BACKGROUND: Despite their importance in reducing maternal mortality, information on access to Mifepristone, Misoprostol, and contraceptive medicines in the Eastern Mediterranean Region is limited. METHODS: A standardized assessment tool measuring access to Mifepristone, Misoprostol, and contraceptive medicines included in the WHO essential medicines list (EML) was implemented in eight countries in the Eastern Mediterranean Region (Afghanistan, Iraq, Lebanon, Libya, Morocco, Palestine, Pakistan, and Somalia) between 2020-2021. The assessment focused on five access measures: 1) the inclusion of medicines in national family planning guidelines; 2) inclusion of medicines in comprehensive abortion care guidelines; 3) inclusion of medicines on national essential medicines lists; 4) medicines registration; and 5) procurement and forecasting of Mifepristone, Misoprostol, and contraceptive medicines. A descriptive analysis of findings from these eight national assessments was conducted. RESULTS: Only Lebanon and Pakistan included all 12 contraceptives that are enlisted in the WHO-EML within their national family planning guidelines. Only Afghanistan and Lebanon included mifepristone and mifepristone-misoprostol combination in post-abortion care guidelines, but these medicines were not included in their national EMLs. Libya and Somalia lacked a national regulatory authority for medicines registration. Most contraceptives included on the national EMLs for Lebanon, Morocco and Pakistan were registered. Misoprostol was included on the EMLs-and registered-in six countries (Afghanistan, Iraq, Lebanon, Morocco, Palestine, and Pakistan). However, only three countries procured misoprostol (Iraq, Morocco, and Somalia). CONCLUSION: These findings can guide efforts aimed at improving the availability of Mifepristone, Misoprostol, and contraceptive medicines in the Eastern Mediterranean Region. Opportunities include expanding national EMLs to include more options for Mifepristone, Misoprostol, and contraceptive medicines and strengthening the registration and procurement systems to ensure these medicines' availability were permitted under national law and where culturally acceptable.

Ensuring access to Mifepristone, Misoprostol, and contraceptive medicines is critical to improving women's health, and more specifically reducing maternal mortality and improving women's sexual and reproductive health in the Eastern Mediterranean Region.The aim of this study was to analyse findings from national assessments to capture information on the implementation of relevant policies and procedures. Those were the policies that ensure access to Mifepristone, Misoprostol, and contraceptive medicines in the public sector for the eight Eastern Mediterranean Region countries included in the study (Afghanistan, Iraq, Libya, Lebanon, Morocco, Palestine, Pakistan, and Somalia). The assessments were completed between 2020 and 2021.We found that most countries did not include all twelve contraceptives enlisted in the WHO essential medicines list (EML) in their national family planning guidelines. No country had developed a national abortion care guidelines nor included mifepristone (alone or in combination with misoprostol) on national EML. Libya and Somalia lacked a national regulatory authority for medicines registration. Most contraceptives included on the national EMLs for Lebanon, Morocco and Pakistan were registered. Misoprostol was included on the EMLs­and registered­in six countries (Afghanistan, Iraq, Lebanon, Morocco, Palestine, and Pakistan) yet, only three countries procured misoprostol (Iraq, Morocco, and Somalia).Our findings provide evidence on system-level barriers to availability of Mifepristone, Misoprostol, and contraceptive medicines (e.g., lack of guidelines or inclusion on EML, lack of registration and procurement) that can support policy and advocacy efforts to strengthen the pharmaceutical sector to better ensure availability of Mifepristone, Misoprostol, and contraceptive medicines to women in reproductive age at the country-level in accordance with the national law and prevailing culture.

Motivations for using misoprostol for abortion outside the formal healthcare system in Colombia: a qualitative study of women seeking postabortion care in Bogotá and the Coffee Axis.

BACKGROUND: In 2006, a Constitutional Court ruling partially decriminalized abortion in Colombia, allowing the procedure in cases of rape, risk to the health or life of the woman, and fetal malformations incompatible with life. Despite this less prohibitive law, some women and pregnant people preferred self-managing their abortions outside the formal healthcare system, often without accurate information. In 2018, we undertook a study to understand what motivated women to self-manage using medications that they acquired informally. Colombia has since adopted a progressive law in 2022, permitting abortion on request through the 24th week of pregnancy. However, the implementation of this law is still underway. Examining the reasons why women chose to informally self-manage an abortion after 2006 may not only highlight how barriers to legal services persisted at that time, but also could inform strategies to increase knowledge of the current abortion law and improve access to services going forward. METHODS: In-depth interviews were conducted in 2018 with 47 women aged 18 and older who used misoprostol obtained outside of health facilities to induce an abortion, and who were receiving postabortion care in two private clinics. Interviews explored what women knew about the 2006 abortion law which was then in effect, and the reasons why they preferred informal channels for abortion care over formal healthcare services. RESULTS: Women's motivations to use misoprostol obtained outside the formal healthcare system were influenced by lack of trust in the healthcare system along with incomplete and inaccurate knowledge of the abortion law. Conversely, women considered misoprostol obtained outside the healthcare system to be effective, affordable, and easier to access. CONCLUSIONS: Obtaining misoprostol outside the formal healthcare system offered a more accessible and appealing prospect for some women given fears of legal repercussion and stigma toward abortion. Though this preference will likely continue despite the more liberal abortion law, strategies should be implemented to broaden knowledge of the recent change in law and to combat misinformation and stigma. This would support knowledge of and access to legal abortion for those who wish to avail themselves of these services.

Oral misoprostol alone, compared with oral misoprostol followed by oxytocin, in women induced for hypertension of pregnancy: A multicentre randomised trial.

OBJECTIVE: To assess whether, in those requiring continuing uterine stimulation after cervical ripening with oral misoprostol and membrane rupture, augmentation with low-dose oral misoprostol is superior to intravenous oxytocin. DESIGN: Open-label, superiority randomised trial. SETTING: Government hospitals in India. POPULATION: Women who were induced for hypertensive disease in pregnancy and had undergone cervical ripening with oral misoprostol, but required continuing stimulation after artificial membrane rupture. METHODS: Participants received misoprostol (25 micrograms, orally, 2-hourly) or titrated oxytocin through an infusion pump. All women had one-to-one care; fetal monitoring was conducted using a mixture of intermittent and continuous electronic fetal monitoring. MAIN OUTCOME MEASURES: Caesarean birth. RESULTS: A total of 520 women were randomised and the baseline characteristics were comparable between the groups. The caesarean section rate was not reduced with the use of misoprostol (misoprostol, 84/260, 32.3%, vs oxytocin, 71/260, 27.3%; aOR 1.23; 95% CI 0.81-1.85; P = 0.33). The interval from randomisation to birth was somewhat longer with misoprostol (225 min, 207-244 min, vs 194 min, 179-210 min; aOR 1.137; 95% CI 1.023-1.264; P = 0.017). There were no cases of hyperstimulation in either arm. The rates of fetal heart rate abnormalities and maternal side effects were similar. Fewer babies in the misoprostol arm were admitted to the special care unit (10 vs 21 in the oxytocin group; aOR 0.463; 95% CI 0.203-1.058; P = 0.068) and there were no neonatal deaths in the misoprostol group, compared with three neonatal deaths in the oxytocin arm. Women's acceptability ratings were high in both study groups. CONCLUSIONS: Following cervical preparation with oral misoprostol and membrane rupture, the use of continuing oral misoprostol for augmentation did not significantly reduce caesarean rates, compared with the use of oxytocin. There were no hyperstimulation or significant adverse events in either arm of the trial.

Clinical factors associated with subsequent surgical intervention in women undergoing early medical termination of viable or non-viable pregnancies.

Introduction: Mifepristone-misoprostol treatment for medical abortion and miscarriage are safe and effective. This study aimed to assess clinical factors associated with subsequent surgical intervention after medical termination of early viable or non-viable pregnancy. Methods: This retrospective, single-center study included women who underwent medical abortion at Taipei Medical University between January 2010 and December 2019. A total of 1,561 subjects, with 1,080 viable and 481 non-viable pregnancies, who were treated with oral mifepristone 600 mg followed by misoprostol 600 mg 48 h later were included. Data of all pregnancies and medical termination of pregnancy were evaluated using regression analysis. The main outcome was successful termination of pregnancy. Results: The success rate of medical abortion was comparable in women with viable and non-viable (92.13% vs. 92.93%) pregnancies. Besides retained tissue, more existing pregnancies with ultrasonographic findings were found in the non-viable pregnancy group than in the viable pregnancy group (29.4% vs. 14.1%, p = 0.011). Multivariate analysis showed that previous delivery was an independent risk factor for failed medical abortion among all included cases. In women with viable pregnancy, longer gestational age [adjusted odds ratio (aOR): 1.483, 95% confidence interval (CI): 1.224-1.797, p < 0.001] and previous Cesarean delivery (aOR: 2.177, 95% CI: 1.167-40.62, p = 0.014) were independent risk factors for failed medical abortion. Number of Cesarean deliveries (aOR: 1.448, 95% CI: 1.029-2.039, p = 0.034) was an independent risk factor for failed medication abortion in women with non-viable pregnancies. Conclusion: This is the first cohort study to identify risk factors for subsequent surgical intervention in women with viable or non-viable pregnancies who had undergone early medically induced abortions. The success rate of medical abortion is comparable in women with viable and non-viable pregnancies. Previous delivery is an independent risk factor for failed medical abortion. Clinical follow-up may be necessary for women who are at risk of subsequent surgical intervention.

Availability of Mifepristone and Misoprostol in Oregon Pharmacies: A Comparison by Rural and Urban Status.

OBJECTIVES: To evaluate the availability of mifepristone and misoprostol at pharmacies in a state with protective abortion legislation and variation in access by rurality. STUDY DESIGN: Using a secret shopper survey, researchers attempted to contact all community pharmacies in Oregon and evaluate their mifepristone and misoprostol provision. RESULTS: Among the 444 pharmacies surveyed, mifepristone was planned at 19.2%. Misoprostol was available at 77.5%, but stocking issues and medication ordering impact access, without significant difference by rurality. CONCLUSIONS: Pharmacy engagement and support is key to increasing access to these essential medicines, which may be improved through education and referral programs.

Trends in the Management of Miscarriages with the Implementation of the Volunteer Obstetrician Scheme in Selected Primary Health Care Centres in Maiduguri, Northeastern Nigeria.

BACKGROUND: Post-abortion care (PAC) is a crucial component of emergency obstetric care, and many of the primary health care centres (PHC) in the internally displaced person (IDP) camps and host communities in Maiduguri lack it. Improved access to high-quality PACs is essential for meeting the reproductive health needs of the IDPs and reducing the maternal morbidity and mortality that can result from miscarriages. OBJECTIVE: To determine the trend in managing miscarriages in the IDP camps and host communities in Maiduguri and the impact of the volunteer obstetrician scheme (VOS) on PAC. METHODOLOGY: We conducted a longitudinal study in selected PHCs serving IDP camps and host communities in Maiduguri. The study spanned five (5) years, and we compared the management of miscarriages and PAC services one year before the VOS project, two years during the project and two years after the project. During the two-year VOS project, staff manning the PHCs had supportive supervision with hands-on training on PAC. Chi-square for trend and odd ratio with a 95% confidence interval was used as appropriate to compare the trend in PAC services provided during the study period. RESULTS: One thousand eight hundred and eight (1808) women presented with miscarriages, and 1562 (86.4%) required uterine evacuation. Medical evacuation with oral misoprostol was offered to 974 (62.4%), and manual vacuum aspiration (MVA) was used in 422 (27.0%) of the women who needed uterine evacuation. There was a statistically significant rise in the use of medical evacuation throughout the study period (52.2% before VOS, and 71.4% by the second year of VOS) with ꭓ2=41.64 and P<0.001. In comparison, the use of MVA fell from 38.6% in 2015 to 27.7% in 2019 (ꭓ2=34.74 and P<0.001). Similar rising trends were also observed in postabortion family planning acceptance (ꭓ2=22.27, P<0.001). CONCLUSION: The Volunteer Obstetrician Scheme project appears to have improved PAC services, especially medical evacuation and family planning uptake in the PHCs in IDP camps and host communities in Maiduguri, Borno State, Nigeria. We recommend task shifting of PAC services and periodic supportive supervision to ensure the quality of care.

CONTEXTE: Les soins après avortement (PAC) sont une composante cruciale des soins obstétricaux d'urgence, et de nombreux centres de soins de santé primaires (PHC) dans les camps de personnes déplacées internes (PDI) et les communautés d'accueil à Maiduguri en sont dépourvus. Un accès amélioré à des PAC de haute qualité est essentiel pour répondre aux besoins de santé reproductive des PDI et réduire la morbidité et la mortalité maternelles qui peuvent résulter des fausses couches. OBJECTIF: Déterminer la tendance dans la gestion des fausses couches dans les camps de PDI et les communautés d'accueil à Maiduguri et l'impact du Programme de bénévoles obstétriciens (VOS) sur la PAC. MÉTHODOLOGIE: Nous avons mené une étude longitudinale dans des PHC sélectionnés desservant des camps de PDI et des communautés d'accueil à Maiduguri. L'étude a duré cinq (5) ans, et nous avons comparé la gestion des fausses couches et les services de PAC un an avant le projet VOS, deux ans pendant le projet et deux ans après le projet. Pendant les deux ans du projet VOS, le personnel des PHC a bénéficié d'une supervision avec formation pratique sur la PAC. Le chi carré pour la tendance et le rapport de cotes avec un intervalle de confiance de 95% ont été utilisés, le cas échéant, pour comparer la tendance des services de PAC fournis pendant la période de l'étude. RÉSULTATS: Mille huit cent huit (1808) femmes ont présenté des fausses couches, et 1562 (86,4%) ont nécessité une évacuation utérine. Une évacuation médicale avec du misoprostol oral a été proposée à 974 (62,4%), et l'aspiration manuelle sous vide (AMV) a été utilisée chez 422 (27,0%) des femmes ayant besoin d'une évacuation utérine. On a observé une augmentation statistiquement significative de l'utilisation de l'évacuation médicale tout au long de la période de l'étude (52,2% avant le VOS et 71,4% la deuxième année du VOS) avec ꭓ2=41,64 et P<0,001. En revanche, l'utilisation de l'AMV est passée de 38,6% en 2015 à 27,7% en 2019 (ꭓ2=34,74 et P<0,001). Des tendances similaires à la hausse ont également été observées dans l'acceptation de la planification familiale après avortement (ꭓ2=22,27, P<0,001). CONCLUSION: Le projet de Programme de bénévoles obstétriciens semble avoir amélioré les services de PAC, en particulier l'évacuation médicale et l'acceptation de la planification familiale dans les PHC des camps de PDI et des communautés d'accueil à Maiduguri, dans l'État de Borno, au Nigéria. Nous recommandons de déléguer les services de PAC et une supervision de soutien périodique pour garantir la qualité des soins. MOTS-CLÉS: Communauté d'accueil, Camps de PDI, Aspiration manuelle sous vide, Évacuation médicale, Misoprostol, Soins après avortement.

Mifepristone and Misoprostol in California pharmacies after modifications to the Risk Evaluation and Mitigation Strategy Program.

In January 2023, the Food & Drug Administration modified the Risk Evaluation and Mitigation Strategy (REMS) program regulating mifepristone to allow direct dispensation from retail pharmacies. In June 2023, we conducted a random, distributive survey of pharmacies in California using secret shopper methodology to investigate the feasibility of accessing mifepristone. One pharmacy had mifepristone immediately available (<24 hours) and misoprostol availability was limited. Accessibility to misoprostol varied by type of pharmacy (p<0.01), but not by region. Even in a reproductive freedom state, access to mifepristone and misoprostol from outpatient retail pharmacies remains limited.

"That's a tricky one": Access to misoprostol for early pregnancy loss in retail pharmacies across Arizona.

OBJECTIVE: To describe same-day availability of misoprostol for medical management of early pregnancy loss (EPL) at Arizona pharmacies. STUDY DESIGN: We performed a simulated-patient mixed-methods study of Arizona pharmacies from October 2022 - February 2023 documenting misoprostol availability and describing pharmacy staff responses. RESULTS: Of 941 pharmacies included, 703 (75%) could fill a misoprostol prescription same-day. Ability to fill prescriptions and reasons why the prescription could not be filled varied by pharmacy type. National chain pharmacies most frequently had misoprostol available, but also most commonly reported policies restricting dispensing. CONCLUSIONS: Barriers exist to filling misoprostol prescriptions for EPL in Arizona that could impact patient care.

Development and validation of a stability-indicating method, structural elucidation of new degradation products from misoprostol by LC-MS time-of-flight, and an ex vivo study of vaginal permeation.

Misoprostol (MSP) is commonly prescribed in obstetrics and gynecology clinical practice for labor induction, cervical ripening, first-trimester pregnancy termination, and the treatment of postpartum hemorrhage. Furthermore, there is a lack of comprehensive discussion evaluating how different commercially available formulations influence the overall efficacy of MSP, even though reports indicate issues with the quality of these formulations, particularly regarding stability and vaginal absorption processes. This study investigates the stability of MSP under acidic conditions and its in vitro permeation using swine vaginal mucosa. A forced degradation study was conducted using 0.2 M HCl, and a high-efficiency LC method was developed. Three degradation products were identified and characterized using electrospray ionization-high-resolution quadrupole-time-of-flight-MS, with respective m/z values of 391.2508, 405.2705, and 387.2259, respectively. These results suggest that the degradation mechanism involves dehydration of the ß-hydroxy ketone moiety, followed by isomerization to its most resonance-stable form and de-esterification. Finally, the in vitro permeation study revealed that the esterified form of MSP was unable to permeate the mucosa and required prior degradation for any component to be detected in the receptor fluid.

A Randomized Controlled Trial Comparing the Management of Incomplete Abortion with Oral 600 mg Misoprostol with Manual Vacuum Aspiration (MVA).

Introduction: In the first trimester, almost one in five identified pregnancies end in spontaneous miscarriage, and another 22% result in induced abortion. After a spontaneous and/or induced abortion, there may be retained products of conception (POC). Because of its relatively poor efficacy and the unpredictability of the time interval until spontaneous evacuation, expectant treatment is not often chosen by healthcare professionals. In view of these facts, the current study's objective was to weigh the effectiveness of MVA and oral misoprostol 600 mg in managing incomplete abortion. Materials and Procedures: The investigation was conducted at the tertiary care center in India. The survey was conducted for one year. Subjects were selected from those attending the department for either spontaneous or induced abortions. A total of 230 women were randomly assigned to receive the interventions of a single dose of oral misoprostol 600 mcg or MVA. They were equally distributed to two groups and observed for the various parameters of success, signs and symptoms, satisfaction, and complications. The obtained values were compared statistically for the significance at <0.05 of P values. Results: Of the 200 subjects (30 lost to follow-up), there was no significant variance in the demographics, clinical outcomes, and complications between the groups. However, the pain, fever, shivering, and satisfaction parameters were statistically variant between the groups. Fever, shivering, and pain were lower for the MISO subjects while satisfaction was reported higher from subjects in MISO group. Conclusion: MISO and MVA are acceptable, safe, and efficient therapies for first-trimester un-complicated incomplete abortion. Nonetheless, misoprostol appears to be a marginally superior option to MVA in terms of accessibility, low therapy costs, reduced pain, and reduced demand for specialized personnel or equipment.

Multi-target mechanism of misoprostol in pregnancy termination based on network pharmacology and molecular docking.

Misoprostol is a prostaglandin analogue that contracts the uterus, prompting the expulsion of the embryo. No systematic evaluation of the mechanisms of misoprostol has previously been performed. In this study, known targets of misoprostol were obtained from the DrugBank database; potential targets of misoprostol were predicted using data from the SwissTargetPrediction and PharmMapper databases; and the main targets of pregnancy termination were obtained from the GeneCards database. The protein-protein interaction (PPI) network of the shared genes between misoprostol and pregnancy termination was constructed using data from the STRING database, and the "misoprostol-pregnancy termination-pathway" network was constructed and potential targets was verified through molecular docking. We analyzed 37 shared target genes and obtained a network diagram of 134 potential targets, which the core therapeutic targets were HSP90AA1, EGFR, and MAPK1. GO functional and KEGG pathway enrichment analyses showed that misoprostol can modulate the VEGF signaling pathway, calcium signaling pathway, and NF-κB signaling pathway in pregnancy termination and mainly interferes with protein phosphorylation, cell localization, and protein hydrolysis regulation processes. This research illustrates the mechanism underlying the pharmacological effect of misoprostol, namely pregnancy termination. However, further experimental verification is warranted for optimal use of misoprostol during clinical practice.

Le misoprostol est un analogue des prostaglandines qui contracte l'utérus, provoquant l'expulsion de l'embryon. Aucune évaluation systématique des mécanismes du misoprostol n'a été réalisée auparavant. Dans cette étude, les cibles connues du misoprostol ont été obtenues à partir de la base de données DrugBank ; Les cibles potentielles du misoprostol ont été prédites à l'aide des données des bases de données SwissTargetPrediction et PharmMapper ; et les principales cibles de l'interruption de grossesse ont été obtenues à partir de la base de données GeneCards. Le réseau d'interaction protéine-protéine (IPP) des gènes partagés entre le misoprostol et l'interruption de grossesse a été construit à l'aide des données de la base de données STRING, et le réseau « voie d'interruption de grossesse-misoprostol ¼ a été construit et les cibles potentielles ont été vérifiées par amarrage moléculaire. Nous avons analysé 37 gènes cibles partagés et obtenu un diagramme de réseau de 134 cibles potentielles, dont les principales cibles thérapeutiques étaient HSP90AA1, EGFR et MAPK1. Les analyses d'enrichissement des voies fonctionnelles GO et KEGG ont montré que le misoprostol peut moduler la voie de signalisation VEGF, la voie de signalisation du calcium et la voie de signalisation NF-κB lors de l'interruption de grossesse et interfère principalement avec les processus de phosphorylation des protéines, de localisation cellulaire et de régulation de l'hydrolyse des protéines. Cette recherche illustre le mécanisme sous-jacent à l'effet pharmacologique du misoprostol, à savoir l'interruption de grossesse. Cependant, une vérification expérimentale plus approfondie est justifiée pour une utilisation optimale du misoprostol au cours de la pratique clinique.

Comparative study of second-line labor induction methods in patients with unfavorable cervix after first-line low-dose oral misoprostol.

OBJECTIVE: The present study aimed to evaluate low-dose oral misoprostol induction, and compare different methods used in second-line induction in patients with a Bishop score less than 6. METHODS: This retrospective study analyzed the medical history and courses of pregnancy of all patients induced with first-line of low-dose oral misoprostol (50 µg every 4 h with a total of 200 µg/24 h) from April 2021 to June 2022 in a university hospital center, and reported outcomes according to the second-line method of induction. RESULTS: Among 437 labor inductions with low-dose oral misoprostol, 120 patients required a second-line induction. Predictive factors of first-line failure were higher body mass index (P = 0.011), absence of premature rupture of membranes (P = 0.021) and earlier term of pregnancy (P < 0.001). Regarding second methods of induction of labor, time from induction to delivery was shorter in the oxytocin group than the dinoprostone and misoprostol groups (24.0 vs. 41 and 51.0 h, respectively; P < 0.001), and was also significantly shorter in the dinoprostone than the misoprostol group (P = 0.048). Cesarean section rates did not differ between the three groups (P = 0.651). There were no clinically significant differences in adverse events between the groups. CONCLUSION: Normal body mass index, previous rupture of membranes and later term of induction of labor were the three favoring success factors during first-line oral misoprostol. In cases of a Bishop score <6, oxytocin may be the best option to reduce duration to delivery, with the same maternal-fetal outcomes, including a similar rate of vaginal delivery.

Tratamiento médico del aborto del primer trimestre: igual eficacia, más eficiencia / Medical treatment of abortion in the first trimester: Equal effectiveness, more efficiency

Antecedentes: La pérdida gestacional precoz acontece en el 10-20% de todas las gestaciones clínicas, siendo el 85% previos a la semana 12 de amenorrea. El aborto involuntario conlleva una carga muy significativa en los recursos destinados a sanidad, alcanzado un coste económico nacional en Reino Unido de 471 millones de libras esterlinas por año (533,06 millones de euros), cifra extrapolable a otros países industrializados. Según una revisión sistemática reciente no hay ensayos bien diseñados en gestaciones del primer trimestre que arrojen una evidencia consolidada sobre cuál es el mejor método de tratamiento de aborto del primer trimestre y existen diferentes estudios que han tratado de evidenciar reducción de costes con resultados contradictorios. Material y métodos: Se realiza un estudio de diseño observacional, retrospectivo y longitudinal. Se revisaron 892 pacientes diagnosticadas de aborto espontáneo durante el primer trimestre de gestación, en el periodo comprendido entre enero de 2013 y diciembre de 2016. En nuestro estudio hemos querido evaluar la efectividad del misoprostol vaginal como tratamiento médico para el aborto espontáneo en el primer trimestre, en comparación con el legrado obstétrico/evacuador y, cuantificar la diferencia en los costos de ambos procedimientos a través de un estudio de minimización de costes. Resultados: De las 892 pacientes reclutadas, se realizó tratamiento médico con misoprostol en 517 (57,95%) y tratamiento quirúrgico mediante legrado evacuador en 375 (42,05%). La efectividad del tratamiento médico fue del 82% (426/517). Con respecto al tratamiento quirúrgico la efectividad resultó del 100%. La tasa de éxito del tratamiento médico fue superior en el subgrupo de pacientes con aborto incompleto (92,9%), en comparación con los grupos de gestación anembrionada (85,7%) y aborto diferido (78,2%). Conclusiones: El tratamiento médico del aborto es un manejo seguro y aceptado por las pacientes...(AU)

Background: Early pregnancy loss occurs in 10-20% of all clinical pregnancies, 85% being prior to week 12 of amenorrhea. Miscarriage entails a very significant burden on healthcare resources, reaching a national economic cost in the United Kingdom of £471 million per year (€533.06 million), a figure that can be extrapolated to other industrialized countries. According to a recent systematic review, there are no well-designed trials in first-trimester pregnancies that provide consolidated evidence on what is the best first-trimester abortion treatment method, and there are different studies that have tried to demonstrate cost reduction with contradictory results. Material and methods: An observational, retrospective and longitudinal design study was carried out. 892 patients diagnosed with spontaneous abortion during the first trimester of pregnancy were reviewed, in the period between January 2013 and December 2016. In our study, we wanted to evaluate the efficacy of vaginal misoprostol as a medical treatment for spontaneous abortion in the first trimester, in comparison with obstetric curettage-evacuator, and to quantify the difference in the costs of both procedures through a cost minimization study. costs. Results: Of the 892 recruited patients, medical treatment with misoprostol was performed in 517 (57.95%) and surgical treatment by curettage in 375 (42.05%). The effectiveness of medical treatment was 82% (426/517). With respect to surgical treatment the effectiveness of 100%. The success rate of medical treatment was higher in the subgroup of patients with incomplete abortion (92.9%), compared to the anembryonic gestation (85.7%) and delayed abortion (78.2%) groups. Conclusions: The medical treatment of abortion is a safe management and accepted by the patients. The adequate selection of candidate patients leads to an increase in the success rate and a decrease in costs...(AU)

Medical management of early pregnancy loss with mifepristone and misoprostol in emergency departments compared to a Complex Family Planning office: Implementation of a COVID-19 institutional policy change.

OBJECTIVES: To evaluate the implementation of mifepristone and misoprostol for medical management of early pregnancy loss (EPL) in emergency departments (EDs) by comparing efficacy, complication, and follow-up rates for patients treated in EDs to the Complex Family Planning (CFP) outpatient office. STUDY DESIGN: In COVID-19's first wave, we expanded medical management of EPL to our EDs. This retrospective study evaluated 72 patients receiving mifepristone and misoprostol for EPL from April 1, 2020 to March 31, 2021, comparing treatment success, safety outcomes, and follow-up rates by location. RESULTS: Thirty-three (46%) patients received care in the ED and 39 (54%) at CFP. Treatment success was lower in EDs (23, 70%) compared to CFP (34, 87%), but after adjusting for insurance status and pregnancy type (miscarriage, uncertain viability, unknown location), this was not significant: adjusted odds ratio 0.48 (95% CI 0.13-1.81). More ED patients underwent emergent interventions (3 vs 0) including two emergent uterine aspirations, one uterine artery embolization, and two blood transfusions. Two cases were attributed to misdiagnosis (cesarean scar and cervical ectopic pregnancies interpreted as incomplete miscarriages) and one to guideline nonadherence. No complications occurred in the CFP group. Follow-up rates were over 80% in both groups. More ED patients engaged in telehealth follow-up (67% vs 18%, p ≤ 0.0001). CONCLUSIONS: In this small sample, we observed a trend toward less successful treatment in the ED compared to the CFP office. Both correctly making uncommon diagnoses and adhering to new guidelines presented implementation challenges. IMPLICATIONS: Implementing mifepristone and misoprostol for EPL in our EDs achieved lower rates of pregnancy resolution compared to outpatient management. Complex uncommon diagnoses and implementing new care pathways in EDs may have contributed to complications and highlighted opportunities for improvement. Additional studies are needed to further quantify safety outcomes for EPL management in EDs.

Evaluation of the effect of Nigella sativa oil on the outcome of missed abortion in women: A randomized double-blind clinical trial.

Background and Aim: Due to the concern about the side effects of chemical drugs and their ineffectiveness, the use of natural compounds as alternatives or complementary therapies has received increasing attention. The purpose of this study was to investigate the effect of Nigella sativa oil on the outcome of missed abortion. Methods: In this double-blind clinical trial, 70 nulliparous pregnant women referred to Hajar Hospital and Imam Ali clinics of Shahrekord and had missed abortion before the 12-week gestational age were selected and randomly divided into two interventions and control groups. The intervention group received 5 g of Nigella sativa oil alone daily for up to 3 days and the control group received a placebo. In case of nonresponse, 3 days after the last dose of medication or placebo, 800 µg of misoprostol (vaginal) were used. Data were analyzed by SPSS software. The chi-square test, Fisher's exact test, independent t-test and paired t-test were used for analytical statistics. Results: According to the results, 18 cases (51.4%) in the intervention group and seven cases (20%) in the control group showed complete evacuation of uterine contents which had a significant difference (p < 0.05). The frequency of vagina physical examination and type of hemorrhage did not show any significant difference between the two groups before and after the intervention. After the intervention, human chorionic gonadotropin (HCG) was significantly decreased in the intervention group but did not change in the control group (p < 0.05). The frequency of adverse events in the intervention group was three (8.6%) and in the control group was one (2.9%) which had no significant difference. Conclusion: Nigella sativa improves the outcome of missed abortion by reducing HCG and facilitating cervix dilatation and delivery of uterine contents.

Comparing the outcomes of termination of second trimester pregnancy with a live fetus using intravaginal misoprostol between women with and without previous cesarean section.

OBJECTIVE: To compare the outcomes of termination of pregnancy with live fetuses in the second trimester (14-28 weeks), using misoprostol 400 mcg intravaginal every 6 h, between women with previous cesarean section (PCS) and no previous cesarean section (no PCS). METHODS: A comparative study was conducted on a prospective database of pregnancy termination in the second trimester, Chiang Mai university hospital. Inclusion criteria included: (1) singleton pregnancy; (2) gestational age between 14 and 28 weeks; and (3) pregnancy with a live fetus and medically indicated for termination. The participants were categorized into two groups; PCS and no PCS group. All were terminated using misoprostol 400 mcg intravaginal every 6 h. The main outcomes were induction to fetal delivery interval and success rate, defined as fetal delivery within 48 h. RESULTS: A total of 238 women, including 80 PCS and 158 no PCS, were recruited. The success rate of fetal delivery within 48 h between both groups was not significantly different (91.3% vs. 93.0%; p-value 0.622). The induction to fetal delivery interval were not significantly different (1531 vs. 1279 min; p-value > 0.05). Gestational age was an independent factor for the success rate and required dosage of misoprostol. The rates of most adverse effects of misoprostol were similar. One case (1.3%) in the PCS group developed uterine rupture during termination, ending up with safe and successful surgical removal and uterine repair. CONCLUSION: Intravaginal misoprostol is highly effective for second trimester termination of pregnancy with PCS and those with no PCS, with similar success rate and induction to fetal delivery interval. Gestational age was an independent factor for the success rate and required dosage of misoprostol. Uterine rupture could occur in 1.3% of PCS, implying that high precaution must be taken for early detection and proper management. SYNOPSIS: Intravaginal misoprostol is highly effective for termination of second trimester pregnancy with a live fetus, with a comparable success rate between women with and without previous cesarean section, with a 1.3% risk of uterine rupture among women with previous cesarean section.

Comparison of Misoprostol with Foley Catheter vs Misoprostol alone for Cervical Ripening and Induction of Labor in Patients with Premature Rupture of Membrane: A Randomized Clinical Trial Study.

Background: This study evaluates the effect of misoprostol alone in comparison with misoprostol with Foley catheter in preparing the cervix for induction of labor in women with premature rupture of the amniotic sac. Materials and Methods: This randomized clinical trial study was performed from 2017 to 2019 on 206 pregnant women with singleton pregnancy and gestational age more than 36 weeks, whose rupture of the amniotic sac had occurred less than 12 hours and had a Bishop score less than 4. These women were randomly assigned to two groups of Foley catheters with misoprostol (intervention group, P = 103) or misoprostol alone (control group, P = 103) to induce labor. In both groups, sublingual misoprostol (25 micrograms) was administered at intervals of 4-6 hours. The collected data were analyzed by SPSS.21 software. Results: There is no significant difference between age and Bishop score in the two groups (P = 0.19, P = 0.31, respectively). Lower doses (0 to 3) of misoprostol were used in the intervention group versus 0 to 5 doses in the control group (P = 0.001). Delivery time was shorter in the intervention group (10.83 hours vs. 13.10 hours in the control group, P = 0.001). Also, the probability of complications such as fever, tachysystole, and hospitalization of an infant in the neonatal intensive care unit (NICU) did not increase. Conclusion: An intracervical Foley catheter with misoprostol is more effective in inducing labor in pregnancies with premature rupture of the membranes than using misoprostol alone and can be a safe and effective option.

Medical treatment for early pregnancy loss following in vitro fertilization compared to spontaneous pregnancies.

BACKGROUND: Misoprostol is a well-studied medical treatment for early pregnancy loss (EPL), with success rates ranging between 70 and 90%. However, treatment failure is associated with major patient discomfort, including the need for surgical intervention to evacuate the uterus. It was previously reported that medical treatment was especially successful among women who conceived after in vitro fertilization (IVF). We aimed to study if there is a difference in rates of medical treatment failures for EPL between pregnancies conceived by IVF and spontaneous pregnancies. METHODS: In this retrospective cohort study, we included all women who underwent medical treatment for EPL at our institute between 07/2015 and 12/2020. Treatment outcome was compared between IVF and spontaneous pregnancies. Treatment failure was defined as a need for surgical intervention, namely, dilation & curettage (D&C) and/or hysteroscopy, due to retained products of conception, which was defined as a gestational sac or endometrial thickness greater than 15 mm in a TVS scan. RESULTS: Overall, 775 patients were included, of which 195 (169/775 = 25.1%) ultimately required surgical intervention. There was no difference between the study groups in the rate of treatment failure. However, among IVF pregnancies, the rate of emergency D&C was lower (3.6% vs. 9.8%, p = 0.001), compared to spontaneous group. CONCLUSION: In cases of medical treatment for EPL, IVF pregnancies had no differences in rates of treatment failure compared to spontaneous pregnancies. That being said, IVF pregnancies have lower chances to undergo emergency D&C, compared to spontaneous pregnancies.

Methods for the induction of labor: efficacy and safety.

This review assessed the efficacy and safety of pharmacologic agents (prostaglandins, oxytocin, mifepristone, hyaluronidase, and nitric oxide donors) and mechanical methods (single- and double-balloon catheters, laminaria, membrane stripping, and amniotomy) and those generally considered under the rubric of complementary medicine (castor oil, nipple stimulation, sexual intercourse, herbal medicine, and acupuncture). A substantial body of published reports, including 2 large network meta-analyses, support the safety and efficacy of misoprostol (PGE1) when used for cervical ripening and labor induction. Misoprostol administered vaginally at doses of 50 µg has the highest probability of achieving vaginal delivery within 24 hours. Regardless of dosing, route, and schedule of administration, when used for cervical ripening and labor induction, prostaglandin E2 seems to have similar efficacy in decreasing cesarean delivery rates. Globally, although oxytocin represents the most widely used pharmacologic agent for labor induction, its effectiveness is highly dependent on parity and cervical status. Oxytocin is more effective than expectant management in inducing labor, and the efficacy of oxytocin is enhanced when combined with amniotomy. However, prostaglandins administered vaginally or intracervically are more effective in inducing labor than oxytocin. A single 200-mg oral tablet of mifepristone seems to represent the lowest effective dose for cervical ripening. The bulk of the literature assessing relaxin suggests this agent has limited benefit when used for this indication. Although intracervical injection of hyaluronidase may cause cervical ripening, the need for intracervical administration has limited the use of this agent. Concerning the vaginal administration of nitric oxide donors, including isosorbide mononitrate, isosorbide, nitroglycerin, and sodium nitroprusside, the higher incidence of side effects with these agents has limited their use. A synthetic hygroscopic cervical dilator has been found to be effective for preinduction cervical ripening. Although a pharmacologic agent may be administered after the use of the synthetic hygroscopic dilator, in an attempt to reduce the interval to vaginal delivery, concomitant use of mechanical and pharmacologic methods is being explored. Combining the use of a single-balloon catheter with dinoprostone, misoprostol, or oxytocin enhances the efficacy of these pharmacologic agents in cervical ripening and labor induction. The efficacy of single- and double-balloon catheters in cervical ripening and labor induction seems similar. To date, the combination of misoprostol with an intracervical catheter seems to be the best approach when balancing delivery times with safety. Although complementary methods are occasionally used by patients, given the lack of data documenting their efficacy and safety, these methods are rarely used in hospital settings.