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2.
Artigo em Inglês | MEDLINE | ID: mdl-39117023

RESUMO

PURPOSE: To assess young people's interest in advance provision (AP) of medication abortion- receiving mifepristone and misoprostol from a clinician in advance for their future use. METHODS: From November 2022-August 2023 we administered an electronic survey regarding advance provision to patients assigned female at birth at four Bay Area youth-serving clinics. RESULTS: Among 152 people ages 14-24 years (mean 17.9) surveyed, 73.7% (95% CI, 65.9%-80.5%) supported and 46.1% (95% CI, 65.9%-80.5%) were interested in the AP model. AP interest was higher among people who experienced three or more difficulties trying to access reproductive healthcare [70.6% (95% CI 44.0%, 89.7%)] and who experienced food or housing insecurity [60.3% (95% CI 46.6%, 73.0%)]. Most youth (81.6%) had a safe place to store the pills for later use; this proportion was significantly higher among people ages 18-24 years (88.5%) than teens ages 14-17 years (74.3%, p=.025). The most common perceived advantages of AP included being able to have the abortion earlier in pregnancy (61.8%), privacy (57.9%) and convenience (50.7%). Common disadvantages noted included concern that people might take the pills incorrectly (50.0%) or lose the pills (40.1%). CONCLUSIONS: Young people have considerable interest in AP of medication abortion. Further research is needed to document the AP model's feasibility, clinical outcomes, and effect on access for adolescents.

3.
Int J Pharm ; 663: 124564, 2024 Aug 06.
Artigo em Inglês | MEDLINE | ID: mdl-39117062

RESUMO

PURPOSE: The present work seeks to develop, assess and refine a nanoethosomal vaginal in situ gel containing Berberine, aimed at enhancing its efficacy in treating Poly Cystic Ovary Syndrome (PCOS). This formulation aims to augment drug permeation, enable controlled release kinetics, and mitigate oral adverse effects commonly associated with Berberine administration. METHOD: Nanoethosomes formulated using diverse soya lecithin-ethanol concentrations within a 32 full-factorial-design, sought optimal formulations based on particle size and %entrapment-efficiency. Subsequent scrutiny involved PDI, Zeta potential and drug-content evaluation. TEM analysis authenticated morphology, while in vitro drug release from Nanoethosomes was examined. Pluronic F-127 concentrations (16%-21%w/v) were explored for the in situ gel, analyzing pH, gelation time and gelation temperature. The refined gel underwent evaluations for viscosity and in vitro diffusion. In vivo assessment covered pharmacokinetics, vaginal irritancy and Mifepristone-induced PCOS management, validated through histopathological and biochemical analysis, juxtaposing findings across normal, diseased, plain Berberine gel and standard metformin administered groups. RESULTS: Optimized Nanoethosomal Formulation(F3) displayed particle size of 183.5 nm, 82.58 % as %entrapment-efficiency, PDI of 0.137, -50.34 mV as zeta potential and 81.64 ± 1.57 % drug-content. TEM analysis confirmed spherical, nano-sized particles. In vitro studies exhibited 80.45 % drug release over 24 h. The formulated gel with 18 % Pluronic F-127 showed viscosity ranging from 193.01 ± 0.16cps to 1817.08 ± 1.67cps with temperature changes from 25 ± 2.0 °C to 38 ± 2.0 °C. In vitro diffusion revealed 85.99 %drug release from optimized gel. In vivo animal studies demonstrated increased plasma drug concentration, non-irritating properties in vaginal tests, and efficacy in managing Mifepristone-induced PCOS compared to other treatments. Short-term stability evaluations confirmed thermodynamic stability at room-temperature.

4.
J Obstet Gynaecol India ; 74(3): 219-223, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38974737

RESUMO

Background: Modern-day obstetrics recommend induction of labor by medical or mechanical methods where continuation of pregnancy causes detrimental effect to the health of mother or fetus. One of the prerequisites for successful vaginal delivery includes a favorable or ripe cervix. We undertook the present study to find out the safety and efficacy of mifepristone for pre-induction cervical ripening and its effect on Bishop's score in term pregnancy. Methods: A total of 100 patients with term pregnancy were enrolled for this study. 200 mg of mifepristone was administered orally, and efficacy of mifepristone was assessed based on improvement in modified Bishop's score at 48 h. If there was inadequate improvement in Bishop's score after 48 h, additional intracervical cerviprime was administered for induction. Results: Out of 100 patients, 50 women delivered vaginally after administration of mifepristone. Twenty-four patients delivered vaginally within 48 h of administration of mifepristone. We observed the Bishop's score of  6 or more at 48 h in 69% participants. Fifty patients required additional intracervical cerviprime. Thirty participants underwent cesarean section. Mean Modified Bishop's score at 0 h was 1.87 and improved to 6.92 after 48 h after mifepristone. A statistically significant difference was found with mean Bishop's score with p value < 0.005. Conclusion: In our study, we found that mifepristone is a safe and effective cervical ripening agent in term pregnancy with unfavorable cervix. It is well tolerated and leads to significant cervical ripening with improvement in Bishop's score favoring vaginal delivery.

5.
J Obstet Gynaecol India ; 74(3): 250-255, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38974742

RESUMO

Background and Study Objective: Uterine leiomyomas, or fibroids, are prevalent benign gynecological tumors affecting many women during their reproductive years. While surgical excision has long been the gold standard for fibroid treatment, the pharmacological management, including progesterone receptor modulators like mifepristone (RU 486), has garnered attention due to the reduced surgical approaches. However, there is a notable paucity of research on the effectiveness of mifepristone, on the same. This study seeks to evaluate the safety and efficacy of mifepristone in reducing uterine leiomyoma size and alleviating associated symptoms. Methodology: Conducted prospectively, the study enrolled 20 pre-menopausal women, aged 18 years or older, from Nanavati Max Super Speciality Hospital Mumbai, Maharashtra, India. Participants were selected based on specific inclusion criteria, including the presence of at least one uterine myoma with a minimum diameter of 2.5 cm as confirmed by ultrasound. Participants had an average age of 39.75 years and an average BMI of 27.58 kg/m2. Results: The study found that mifepristone significantly reduced uterine volume by 75%, with hemoglobin levels substantially improving from 9 gm/dL initially to 12.51 gm/dL after six months. Pain intensity, assessed using the Visual Analog Scale (VAS) score, gradually decreased from baseline to three-month, with all 20 patients reporting the complete absence of pelvic pain by six months. Conclusion: This prospective study highlights mifepristone's promise as a non-surgical approach to effectively reduce uterine fibroid volume, improve hemoglobin levels, and mitigate uterine blood loss in patients.

6.
Artigo em Inglês | MEDLINE | ID: mdl-38992183

RESUMO

Mifepristone, a progesterone receptor antagonist, was initially used to terminate early pregnancy. As scientific research advanced, it emerged to be effective in the treatment of various tumors and tumor-like conditions such as endometriosis. Despite the therapeutic potential of mifepristone, its therapeutic effect is still far from ideal because the drug is difficult to dissolve and to accumulate in the target tissue sites. To address this issue, mifepristone-loaded nanostructured lipid carriers (Mif-NLC) were prepared by a simple solvent diffusion method and their anti-endometriosis performance and mechanisms were initially investigated. By optimizing the preparation protocol, we obtained uniform and spheroidal Mif-NLC with an average particle size of 280 nm. The encapsulation rate and drug loading capacity were 64.67% ± 0.15% and 2.7% ± 0.014%, respectively, as measured by UV spectrophotometry. The in vitro release kinetics indicated that mifepristone was released from NLC in a sustained-release manner. Compared with free mifepristone, Mif-NLC exhibited enhanced cellular uptake and inhibition of invasion activity in primary mesenchymal cells of endometriosis. A certain reduction in the size of endometriotic cysts was observed in animals compared to controls. The induction of autophagy via Mif-NLC may serve as the molecular mechanism underlying this effect. Furthermore, observation of uterine structures showed negligible toxic effects. This suggested that mifepristone encapsulated in NLC can improve its bioavailability and anti-endometriosis efficacy, which provided a new strategy for the treatment of endometriosis.

7.
Int J Mol Sci ; 25(14)2024 Jul 10.
Artigo em Inglês | MEDLINE | ID: mdl-39062832

RESUMO

Progesterone receptor antagonism is gaining attention due to progesterone's recognized role as a major mitogen in breast tissue. Limited but promising data suggest the potential efficacy of antiprogestins in breast cancer prevention. The present study presents secondary outcomes from a randomized controlled trial and examines changes in breast mRNA expression following mifepristone treatment in healthy premenopausal women. We analyzed 32 paired breast biopsies from 16 women at baseline and after two months of mifepristone treatment. In total, 27 differentially expressed genes were identified, with enriched biological functions related to extracellular matrix remodeling. Notably, the altered gene signature induced by mifepristone in vivo was rather similar to the in vitro signature. Furthermore, this gene expression signature was linked to breast carcinogenesis and notably linked with progesterone receptor expression status in breast cancer, as validated in The Cancer Genome Atlas dataset using the R2 platform. The present study is the first to explore the breast transcriptome following mifepristone treatment in normal breast tissue in vivo, enhancing the understanding of progesterone receptor antagonism and its potential protective effect against breast cancer.


Assuntos
Neoplasias da Mama , Mifepristona , Pré-Menopausa , Receptores de Progesterona , Transcriptoma , Humanos , Feminino , Receptores de Progesterona/metabolismo , Receptores de Progesterona/genética , Mifepristona/farmacologia , Mifepristona/uso terapêutico , Transcriptoma/efeitos dos fármacos , Adulto , Neoplasias da Mama/genética , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/metabolismo , Mama/metabolismo , Mama/efeitos dos fármacos , Mama/patologia , Perfilação da Expressão Gênica
8.
PeerJ ; 12: e17539, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38952964

RESUMO

The association between sleep and the immune-endocrine system is well recognized, but the nature of that relationship is not well understood. Sleep fragmentation induces a pro-inflammatory response in peripheral tissues and brain, but it also activates the hypothalamic-pituitary-adrenal (HPA) axis, releasing glucocorticoids (GCs) (cortisol in humans and corticosterone in mice). It is unclear whether this rapid release of glucocorticoids acts to potentiate or dampen the inflammatory response in the short term. The purpose of this study was to determine whether blocking or suppressing glucocorticoid activity will affect the inflammatory response from acute sleep fragmentation (ASF). Male C57BL/6J mice were injected i.p. with either 0.9% NaCl (vehicle 1), metyrapone (a glucocorticoid synthesis inhibitor, dissolved in vehicle 1), 2% ethanol in polyethylene glycol (vehicle 2), or mifepristone (a glucocorticoid receptor antagonist, dissolved in vehicle 2) 10 min before the start of ASF or no sleep fragmentation (NSF). After 24 h, samples were collected from brain (prefrontal cortex, hypothalamus, hippocampus) and periphery (liver, spleen, heart, and epididymal white adipose tissue (EWAT)). Proinflammatory gene expression (TNF-α and IL-1ß) was measured, followed by gene expression analysis. Metyrapone treatment affected pro-inflammatory cytokine gene expression during ASF in some peripheral tissues, but not in the brain. More specifically, metyrapone treatment suppressed IL-1ß expression in EWAT during ASF, which implies a pro-inflammatory effect of GCs. However, in cardiac tissue, metyrapone treatment increased TNF-α expression in ASF mice, suggesting an anti-inflammatory effect of GCs. Mifepristone treatment yielded more significant results than metyrapone, reducing TNF-α expression in liver (only NSF mice) and cardiac tissue during ASF, indicating a pro-inflammatory role. Conversely, in the spleen of ASF-mice, mifepristone increased pro-inflammatory cytokines (TNF-α and IL-1ß), demonstrating an anti-inflammatory role. Furthermore, irrespective of sleep fragmentation, mifepristone increased pro-inflammatory cytokine gene expression in heart (IL-1ß), pre-frontal cortex (IL-1ß), and hypothalamus (IL-1ß). The results provide mixed evidence for pro- and anti-inflammatory functions of corticosterone to regulate inflammatory responses to acute sleep loss.


Assuntos
Glucocorticoides , Metirapona , Camundongos Endogâmicos C57BL , Mifepristona , Privação do Sono , Animais , Masculino , Metirapona/farmacologia , Privação do Sono/metabolismo , Privação do Sono/tratamento farmacológico , Camundongos , Mifepristona/farmacologia , Glucocorticoides/farmacologia , Interleucina-1beta/metabolismo , Interleucina-1beta/genética , Inflamação/metabolismo , Inflamação/tratamento farmacológico , Fator de Necrose Tumoral alfa/metabolismo , Fator de Necrose Tumoral alfa/genética , Corticosterona/sangue , Sistema Hipotálamo-Hipofisário/efeitos dos fármacos , Sistema Hipotálamo-Hipofisário/metabolismo , Encéfalo/metabolismo , Encéfalo/efeitos dos fármacos , Receptores de Glucocorticoides/metabolismo , Receptores de Glucocorticoides/antagonistas & inibidores , Receptores de Glucocorticoides/genética
9.
Exp Parasitol ; 263-264: 108805, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-39032913

RESUMO

Right up to now, there has not been an effective or safe therapy for trichinellosis. Thus, this study aimed to determine the efficacy of prophylactic and therapeutic regimens of progesterone and mifepristone on the intestinal and muscular phases of experimental Trichinella spiralis infection compared to albendazole. Seven distinct groups of mice were divided as follows: negative, positive, and drug control groups, as well as prophylactic and treatment groups using mifepristone and progesterone. Mice were sacrificed on the 7th and 37th days after infection. Treatment efficacy was evaluated using parasitological techniques, histopathological examination, immunohistochemical staining, and ultrastructural morphological analysis of adult worms by scanning electron microscopy. The mice groups received progesterone (300 ng/ml) and mifepristone (100 ng/ml). They demonstrated a significant improvement in intestinal and muscular inflammation and a statistically significant decline in the adult worm burden and encysted larvae (P < 0.001). Moreover, immunohistochemical staining of vascular endothelial growth factor and mucosal mast cell analyses were coincided with the obtained parasitological results. There was notable destruction and degeneration of the adult worm tegument by using both drugs. The current study pointed out that progesterone and mifepristone may provide new insights regarding the development of vaccines and drug protocols to treat trichinellosis through their combined action in reducing the inflammation, affecting the intestinal immune cell, and decreasing the adult worm burden, and larval capsule development.


Assuntos
Albendazol , Microscopia Eletrônica de Varredura , Mifepristona , Progesterona , Trichinella spiralis , Triquinelose , Animais , Triquinelose/tratamento farmacológico , Camundongos , Trichinella spiralis/efeitos dos fármacos , Trichinella spiralis/ultraestrutura , Mifepristona/uso terapêutico , Mifepristona/farmacologia , Albendazol/uso terapêutico , Albendazol/farmacologia , Feminino , Fator A de Crescimento do Endotélio Vascular , Imuno-Histoquímica , Mastócitos/efeitos dos fármacos , Anti-Helmínticos/uso terapêutico , Anti-Helmínticos/farmacologia , Masculino
10.
Arch Gynecol Obstet ; 2024 Jul 09.
Artigo em Inglês | MEDLINE | ID: mdl-38980347

RESUMO

PURPOSE: This meta-analysis aimed to comprehensively assess the teratogenic risk to offspring associated with continuing pregnancy after administering mifepristone and/or misoprostol during gestation. METHODS: We conducted a systematic search of multiple databases, including PubMed, Web of Science, Embase, Cochrane, CNKI, and CBM, from their inception to February 2024, with no language restrictions. We included cohort and case-control studies that analyzed the teratogenic effects of mifepristone and/or misoprostol on fetuses and newborns. Quality assessment was performed using the Newcastle-Ottawa Scale (NOS). The odds ratios (OR) from individual studies were combined using meta-analysis. Sensitivity testing and heterogeneity analysis were conducted. RESULTS: A total of 13 studies were eligible for inclusion, comprising 5193 cases of congenital malformations and 12,232 controls. CONCLUSION: Our findings indicated that the use of misoprostol during early pregnancy increased the risk of congenital abnormalities in offspring (OR = 2.69; 95% CI: 1.57-4.62). However, the potential teratogenic effect of mifepristone during pregnancy cannot be ruled out. Additionally, the use of mifepristone and/or misoprostol has been linked to a higher risk of certain congenital anomalies, such as hydrocephalus (OR = 3.41; 95% CI: 1.17-9.97), Möbius syndrome (OR = 26.48; 95% CI: 11.30-62.01), and terminal transverse limb defects (OR = 10.75; 95% CI: 3.93-29.41). (PROSPERO, CRD42024522093, 03182024).

11.
Cells ; 13(13)2024 Jun 28.
Artigo em Inglês | MEDLINE | ID: mdl-38994975

RESUMO

Mating in female Drosophila melanogaster causes midgut hypertrophy and reduced lifespan, and these effects are blocked by the drug mifepristone. Eip75B is a transcription factor previously reported to have pleiotropic effects on Drosophila lifespan. Because Eip75B null mutations are lethal, conditional systems and/or partial knock-down are needed to study Eip75B effects in adults. Previous studies showed that Eip75B is required for adult midgut cell proliferation in response to mating. To test the possible role of Eip75B in mediating the lifespan effects of mating and mifepristone, a tripartite FLP-recombinase-based conditional system was employed that provides controls for genetic background. Expression of a Hsp70-FLP transgene was induced in third instar larvae by a brief heat pulse. The FLP recombinase catalyzed the recombination and activation of an Actin5C-GAL4 transgene. The GAL4 transcription factor in turn activated expression of a UAS-Eip75B-RNAi transgene. Inhibition of Eip75B activity was confirmed by loss of midgut hypertrophy upon mating, and the lifespan effects of both mating and mifepristone were eliminated. In addition, the negative effects of mifepristone on egg production were eliminated. The data indicate that Eip75B mediates the effects of mating and mifepristone on female midgut hypertrophy, egg production, and lifespan.


Assuntos
Proteínas de Drosophila , Drosophila melanogaster , Longevidade , Mifepristona , Fatores de Transcrição , Animais , Mifepristona/farmacologia , Feminino , Proteínas de Drosophila/metabolismo , Proteínas de Drosophila/genética , Drosophila melanogaster/efeitos dos fármacos , Drosophila melanogaster/genética , Drosophila melanogaster/fisiologia , Longevidade/efeitos dos fármacos , Longevidade/genética , Fatores de Transcrição/metabolismo , Fatores de Transcrição/genética , Masculino , Comportamento Sexual Animal/efeitos dos fármacos
12.
Artigo em Inglês | MEDLINE | ID: mdl-39074980

RESUMO

On January 30, 2024, over 300 researchers filed an amicus brief in FDA v. Alliance for Hippocratic Medicine, a United States (US) Supreme Court case that could have severely impacted access to mifepristone, one of the two drugs commonly used in medication abortion. The researchers summarize the legal challenges to the US Food and Drug Administration's (FDA's) original approval of mifepristone in 2000 and its 2016 and 2021 decisions modifying mifepristone's Risk Evaluation and Mitigation Strategy (REMS) Program and label, the responses from the FDA and drug manufacturer to the challenges, and the potential implications of the Court's decision on access to mifepristone in the US. The researchers detail how the FDA relied on a robust scientific record analyzing tens of thousands of patient experiences that conclusively demonstrated the safety and effectiveness of the changes to the mifepristone REMS Program and label and urge the Supreme Court to rely on the clear scientific record and preserve access to mifepristone without reimposing restrictions. What follows is a reprint of this brief.

13.
Contraception ; : 110538, 2024 Jul 11.
Artigo em Inglês | MEDLINE | ID: mdl-39002625

RESUMO

OBJECTIVES: To compare self-reported clinical outcomes following medical abortion with mifepristone and misoprostol sourced from either a pharmacy or health clinic. STUDY DESIGN: We conducted a prospective, non-randomized, non-inferiority cohort study across four regions in Ghana, from high-volume pharmacies and health clinics. Participants seeking medical abortion (less than nine weeks' gestation) who met usual medical abortion eligibility criteria were recruited. Data collection included baseline surveys, follow-up phone interviews, and self-reported assessments of medical abortion outcomes. The study aimed to enroll 2000 medical abortion users (1000 from each source). RESULTS: Complete outcome data was available and analyzed from 1958 participants (of 2208 enrolled), with the adjusted risk difference of need for additional treatment to complete the abortion indicating non-inferiority of the pharmacy group compared to the clinic group [-2.3% (95% CI -5.3% to 0.7%)]. Both groups reported low rates of additional treatment (4.9%) and adhered similarly to the abortion regimen. Secondary outcomes showed no significant differences, with moderate acceptability in both groups (65.4% pharmacy, 52.3% facility). Adverse outcomes were rare: one ectopic pregnancy, one blood transfusion and no deaths or other major complications were reported. CONCLUSIONS: Accessing medical abortion pills directly from pharmacies without prior consultation from a provider demonstrated non-inferior self-reported clinical outcomes compared to seeking care from health clinics. The findings align with the growing global evidence supporting the safety and effectiveness of medical abortion self-care. IMPLICATIONS: This study contributes data which support future registration of over-the-counter use of medical abortion drugs up to nine weeks' gestation. Such measures could expand options for safe abortion care, especially in regions where unsafe abortion poses a substantial maternal health risk. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03727308).

14.
Reprod Health ; 20(Suppl 1): 192, 2024 Jun 04.
Artigo em Inglês | MEDLINE | ID: mdl-38835050

RESUMO

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.


Assuntos
Acessibilidade aos Serviços de Saúde , Mifepristona , Misoprostol , Misoprostol/provisão & distribuição , Misoprostol/uso terapêutico , Humanos , Feminino , Mifepristona/provisão & distribuição , Mifepristona/administração & dosagem , Região do Mediterrâneo , Anticoncepcionais/provisão & distribuição , Oriente Médio , Aborto Induzido/estatística & dados numéricos , Aborto Induzido/métodos , Gravidez , Serviços de Planejamento Familiar/normas
15.
Reprod Health ; 20(Suppl 1): 193, 2024 Jun 05.
Artigo em Inglês | MEDLINE | ID: mdl-38840263

RESUMO

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.


Assuntos
Abortivos , Aborto Induzido , Acessibilidade aos Serviços de Saúde , Misoprostol , Humanos , Índia , Aborto Induzido/estatística & dados numéricos , Aborto Induzido/métodos , Feminino , Gravidez , Abortivos/provisão & distribuição , Misoprostol/provisão & distribuição , Mifepristona/provisão & distribuição , Medicamentos Essenciais/provisão & distribuição
16.
Front Med (Lausanne) ; 11: 1188629, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38737765

RESUMO

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.

17.
J Am Board Fam Med ; 37(2): 295-302, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38740468

RESUMO

INTRODUCTION: Providing abortion in primary care expands access and alleviates delays. The 2020 COVID-19 public health emergency (PHE) led to the expansion of telehealth, including medication abortion (MAB). This study evaluates the accessibility of novel telehealth MAB (teleMAB) initiated during the PHE, with the lifting of mifepristone restrictions, compared with traditional in-clinic MAB offered before the PHE at a Massachusetts safety-net primary care organization. METHODS: We conducted a retrospective electronic medical record review of 267 MABs. We describe sociodemographic, care access, and complete abortion characteristics and compare differences between teleMAB and in-clinic MABs using Chi-squared test, fisher's exact test, independent t test, and Wilcoxon rank sum. We conducted logistic regression to examine differences in time to care (6 days or less vs 7 days or more). RESULTS: 184 MABs were eligible for analysis (137 in-clinic, 47 teleMAB). Patients were not significantly more likely to receive teleMAB versus in-clinic MAB based on race, ethnicity, language, or payment. Completed abortion did not significantly differ between groups (P = .187). Patients received care more quickly when accessing teleMAB compared with usual in-clinic MAB (median 3 days, range 0 to 20 vs median 6 days, range 0 to 32; P < . 001). TeleMAB patients had 2.29 times the odds of having their abortion appointment within 6 days compared with in-clinic (95% CI: 1.13, 4.86). CONCLUSION: TeleMAB in primary care is as effective, timelier, and potentially more accessible than in-clinic MAB when in-person mifepristone regulations were enforced. TeleMAB is feasible and can promote patient-centered and timely access to abortion care.


Assuntos
Aborto Induzido , COVID-19 , Acessibilidade aos Serviços de Saúde , Atenção Primária à Saúde , Telemedicina , Humanos , Feminino , Telemedicina/estatística & dados numéricos , Telemedicina/organização & administração , Telemedicina/métodos , Aborto Induzido/métodos , Aborto Induzido/estatística & dados numéricos , Estudos Retrospectivos , Adulto , Atenção Primária à Saúde/organização & administração , Atenção Primária à Saúde/métodos , Gravidez , Massachusetts , Acessibilidade aos Serviços de Saúde/estatística & dados numéricos , SARS-CoV-2 , Adulto Jovem , Mifepristona/administração & dosagem , Mifepristona/uso terapêutico , Abortivos/administração & dosagem
18.
Artigo em Inglês, Chinês | MEDLINE | ID: mdl-38763769

RESUMO

OBJECTIVES: To investigate the effect of subacute exposure of Di (2-ethylhexyl) phthalate (DEHP) on endometrial decidualization in mice. METHODS: CD1 mice were orally administrated with 300 mg·kg-1·d-1 (low-dose group), 1000 mg·kg-1·d-1 (medium-dose group), or 3000 mg·kg-1·d-1 DEHP (1/10 LD50, high-dose group) for 28 days, respectively. The early natural pregnancy model and artificially induced decidualization model were established, and the uterine tissues were collected on D7 of natural pregnancy and D8 of artificially induced decidualization, respectively. The effects of subacute exposure to DEHP on the decidualization of mice were detected by HE staining, Masson staining, TUNEL staining, and Western blotting, respectively. A model of spontaneous abortion was constructed in mice after subacute exposure to 300 mg·kg-1·d-1 DEHP, and the effect of impaired decidualization on pregnancy was investigated by observing the pregnancy outcome on the 10th day of gestation. RESULTS: Compared with the control group, the conception rate was significantly lower in the high-dose DEHP subacute exposure group. HE staining showed that, compared with the control group, the decidual stromal cells in the low- and medium-dose exposure groups were disorganized, the nuclei of the cells were irregular, the cytoplasmic staining was uneven, and the number of polymorphonuclear cells was significantly reduced. Masson staining showed that compared with the control group, the collagen fibers in the decidua region of the DEHP low-dose group and the medium-dose group were more distributed, more abundant and more disorderly. TUNEL staining showed increased apoptosis in the decidua area compared to the control group. Western blotting showed that the expression of BMP2, a marker molecule for endometrial decidualization, was significantly reduced. The abortion rate and embryo resorption rate were significantly higher, and the number of embryos, uterine wet weight, uterine area and placenta wet weight were significantly lower in mice exposed to 300 mg·kg-1·d-1 DEHP than in control mice stimulated by mifepristone abortifacient drug. CONCLUSIONS: Subacute exposure to DEHP leads to impaired endometrial decidualization during early pregnancy and exacerbates the risk of adverse pregnant outcomes in mice.

20.
Contraception ; 137: 110491, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-38763275

RESUMO

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 provisions. 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 differences by rurality. CONCLUSIONS: Pharmacy engagement and support are key to increasing access to these essential medicines, which may be improved through education and referral programs.


Assuntos
Acessibilidade aos Serviços de Saúde , Mifepristona , Misoprostol , Misoprostol/provisão & distribuição , Misoprostol/administração & dosagem , Oregon , Mifepristona/provisão & distribuição , Mifepristona/administração & dosagem , Humanos , Feminino , Farmácias/estatística & dados numéricos , População Rural , Aborto Induzido/legislação & jurisprudência , Aborto Induzido/estatística & dados numéricos , Abortivos não Esteroides/provisão & distribuição , Abortivos não Esteroides/administração & dosagem , Gravidez , População Urbana , Abortivos Esteroides/provisão & distribuição , Abortivos Esteroides/administração & dosagem , Serviços Comunitários de Farmácia/estatística & dados numéricos
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