Asunto(s)
Abortivos , Aborto Inducido , Mifepristona , Misoprostol , Servicios Postales , Adolescente , Adulto , Femenino , Humanos , Embarazo , Adulto Joven , Abortivos/administración & dosificación , Abortivos/efectos adversos , Abortivos/provisión & distribución , Abortivos/uso terapéutico , Aborto Inducido/métodos , Mifepristona/administración & dosificación , Mifepristona/efectos adversos , Mifepristona/provisión & distribución , Mifepristona/uso terapéutico , Misoprostol/administración & dosificación , Misoprostol/efectos adversos , Misoprostol/provisión & distribución , Misoprostol/uso terapéutico , Servicios Farmacéuticos , Estados Unidos , Resultado del TratamientoRESUMEN
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.
Asunto(s)
Aborto Espontáneo , COVID-19 , Servicio de Urgencia en Hospital , Mifepristona , Misoprostol , Humanos , Femenino , Misoprostol/administración & dosificación , Misoprostol/uso terapéutico , Misoprostol/efectos adversos , Mifepristona/administración & dosificación , Mifepristona/uso terapéutico , Mifepristona/efectos adversos , Embarazo , Adulto , Estudios Retrospectivos , Abortivos no Esteroideos/administración & dosificación , Política Organizacional , Servicios de Planificación Familiar , SARS-CoV-2 , Adulto Joven , Resultado del TratamientoRESUMEN
Importance: Several medications have been used to achieve medical abortion in the first trimester of pregnancy. The most commonly used is the combination of mifepristone and misoprostol; however, different doses and routes of administration have been proposed. Objective: The aim of this study was to summarize published data on the effectiveness, adverse effects, and acceptability of the various combinations of mifepristone and misoprostol in medical abortion protocols in the first trimester of pregnancy. Evidence Acquisition: This was a comprehensive review, synthesizing the findings of the literature on the current use of mifepristone and misoprostol for first-trimester abortion. Results: The combination of mifepristone and misoprostol seems to be more effective than misoprostol alone. Regarding the dosages and routes, mifepristone is administered orally, and the optimal dose is 200 mg. The route of administration of misoprostol varies; the sublingual and buccal routes are more effective; however, the vaginal route (800 µg) is associated with fewer adverse effects. Finally, the acceptability rates did not differ significantly. Conclusions: Different schemes for first-trimester medical abortion have been described so far. Future research needs to focus on identifying the method that offers the best trade-off between efficacy and safety in first-trimester medical abortion.
Asunto(s)
Abortivos no Esteroideos , Aborto Inducido , Misoprostol , Embarazo , Femenino , Humanos , Mifepristona/efectos adversos , Misoprostol/efectos adversos , Primer Trimestre del Embarazo , Aborto Inducido/efectos adversos , Abortivos no Esteroideos/efectos adversosRESUMEN
Telehealth abortion has become critical to addressing surges in demand in states where abortion remains legal but evidence on its effectiveness and safety is limited. California Home Abortion by Telehealth (CHAT) is a prospective study that follows pregnant people who obtained medication abortion via telehealth from three virtual clinics operating in 20 states and Washington, DC between April 2021 and January 2022. Individuals were screened using a standardized no-test protocol, primarily relying on their medical history to assess medical eligibility. We assessed effectiveness, defined as complete abortion after 200 mg mifepristone and 1,600 µg misoprostol (or lower) without additional intervention; safety was measured by the absence of serious adverse events. We estimated rates using multivariable logistic regression and multiple imputation to account for missing data. Among 6,034 abortions, 97.7% (95% confidence interval (CI) = 97.2-98.1%) were complete without subsequent known intervention or ongoing pregnancy after the initial treatment. Overall, 99.8% (99.6-99.9%) of abortions were not followed by serious adverse events. In total, 0.25% of patients experienced a serious abortion-related adverse event, 0.16% were treated for an ectopic pregnancy and 1.3% abortions were followed by emergency department visits. There were no differences in effectiveness or safety between synchronous and asynchronous models of care. Telehealth medication abortion is effective, safe and comparable to published rates of in-person medication abortion care.
Asunto(s)
Aborto Inducido , Aborto Espontáneo , Misoprostol , Telemedicina , Embarazo , Femenino , Humanos , Estados Unidos , Estudios Prospectivos , Aborto Inducido/efectos adversos , Aborto Inducido/métodos , Mifepristona/efectos adversos , Misoprostol/efectos adversosRESUMEN
OBJECTIVE: To compare the success rates of medical management using a combined mifepristone and misoprostol protocol in cases of early pregnancy loss (EPL) between women who conceived without medical assistance and those who conceived through in vitro fertilization (IVF), after fresh or frozen embryo transfer, and evaluate for the predictive factors of success, time to first passage of tissue, and time to complete resolution of pregnancy. DESIGN: Retrospective cohort study. SETTING: University hospital. PATIENT(S): Women who presented with EPL below 13 weeks of gestation between June 2013 and July 2021 who were managed medically with mifepristone 200 mg orally and misoprostol 800 mcg vaginally were included in the study. INTERVENTION(S): Medical management with mifepristone and misoprostol; conception without medical assistance vs. post-IVF, after fresh or frozen embryo transfer. MAIN OUTCOME MEASURE(S): We evaluated overall success and performed subgroup analysis according to the mode of conception and compared fresh vs. frozen-thawed embryo transfers for IVF pregnancies. In all groups, we also calculated success according to gestational age and compared the time to first passage of tissue. The potential predictive factors of treatment success were analyzed. The side effects and complications of treatment were recorded. RESULT(S): A total of 930 women were included in the study, 99 (11%) of whom achieved pregnancy after IVF. The overall success of medical treatment was 89% with no statistically significant difference according to the mode of conception (89% vs. 89%) or type of transfer (fresh 89% vs. frozen 89%). Only lower gestational age by sonography was independently predictive of treatment success, showing a negative regression coefficient of ß = -0.333 and an odds ratio of 0.717. The mean time to first passage of tissue was 5.0 ± 2.1 hours. Altogether, 666 women (72%) showed pregnancy resolution on the day of medication administration, an additional 110 women at 1-week follow-up, and a further 74 women after ≥4 weeks on ultrasound. CONCLUSION(S): Medical management of EPL with mifepristone and misoprostol is a highly successful treatment option that results in completed abortion in a timely fashion in both pregnancies conceived without medical assistance and those conceived after IVF.
Asunto(s)
Aborto Espontáneo , Transferencia de Embrión , Fertilización In Vitro , Mifepristona , Misoprostol , Humanos , Femenino , Embarazo , Estudios Retrospectivos , Adulto , Mifepristona/administración & dosificación , Mifepristona/efectos adversos , Mifepristona/uso terapéutico , Fertilización In Vitro/métodos , Misoprostol/administración & dosificación , Misoprostol/efectos adversos , Aborto Espontáneo/epidemiología , Aborto Espontáneo/etiología , Transferencia de Embrión/métodos , Resultado del Tratamiento , Abortivos no Esteroideos/administración & dosificación , Abortivos no Esteroideos/efectos adversos , Abortivos Esteroideos/administración & dosificación , Abortivos Esteroideos/efectos adversos , Administración OralRESUMEN
OBJECTIVES: This study aimed to assess the feasibility, safety, and acceptability of asynchronous screening for medication abortion eligibility using a programmed questionnaire. STUDY DESIGN: For this study, we developed an informational website about medication abortion with a linked questionnaire programmed to produce a conclusion regarding eligibility according to standard criteria. We enrolled people in Colorado and Minnesota who submitted questionnaires indicating eligibility. A study physician reviewed each questionnaire and medical records if available and determined whether the responses warranted treatment without a synchronous clinical consultation or ultrasound. If so, the physician prescribed a standard regimen of mifepristone and misoprostol. We collected posttreatment data on abortion outcome, adverse events, and satisfaction. RESULTS: We received questionnaires from 197 individuals, of whom 160 remained in the study until the physician made a final treatment decision. Physicians prescribed medication abortion to 156 (97.5%) individuals based on the questionnaire responses, whereas four needed further assessment to confirm eligibility. Of the 156 individuals, 130 had sufficient follow-up to assess abortion outcome, and 123 (95%) had complete medication abortions without additional treatment. One participant was hospitalized for bleeding, and one expelled a 15-week fetus; however, it is not clear that conventional synchronous history-based screening would have averted these events. Of the 197 questionnaires, 42% were submitted outside business hours. On satisfaction questionnaires, 134 (96%) of 144 participants said they would recommend the study to a friend who needed an abortion. CONCLUSIONS: Data from this pilot project suggest that providing medication abortion based only on a self-administered, programmed questionnaire is likely to be effective, safe, efficient, and acceptable. IMPLICATIONS: A programmed self-administered patient questionnaire to assess eligibility for medication abortion could reduce the cost of the service, augment clinic efficiency, improve quality of care, and enhance access to abortion.
Asunto(s)
Aborto Inducido , Misoprostol , Embarazo , Femenino , Humanos , Proyectos Piloto , Mifepristona/efectos adversos , Misoprostol/efectos adversos , ColoradoRESUMEN
AIM: This pilot study aimed to assess the utility of an oral progesterone treatment protocol for women who commenced medical abortion and then changed their mind and wished instead to maintain their pregnancy. METHODS: The Progesterone-After-Mifepristone-pilot for efficacy and reproducibility (PAMper) trial was designed as a prospective single-arm pilot clinical trial, conducted via telehealth. Women aged 18 to 45 years in Australia who reported ingesting mifepristone within the last 72 h to initiate medical abortion and had not taken misoprostol were included. Initial contact was by a web-based form. Following informed consent, participants were prescribed oral progesterone to be taken 400 mg twice per day for 3 days then 400 mg at night until completion of a 19 day course. Pregnancy viability was assessed by ultrasound scan after 14 days of progesterone treatment. RESULTS: Between October 2020 and June 2021, nine women contacted the PAMper trial, of whom six enrolled and commenced progesterone treatment. These women reported ingesting mifepristone at 40-70 days of gestation, with progesterone being commenced within 5.7-72 h of mifepristone ingestion. Five participants had ongoing, live pregnancies at the primary endpoint (ultrasound at >2 weeks). One participant had a miscarriage after 9 days of progesterone treatment. There were no clinically significant adverse events. CONCLUSION: This small study demonstrated a clinically sound protocol for researching the use of progesterone-after-mifepristone for women in this circumstance. Results of this pilot study support the need for further larger scale trials in this field.
Asunto(s)
Abortivos Esteroideos , Aborto Inducido , Misoprostol , Embarazo , Humanos , Femenino , Mifepristona/efectos adversos , Progesterona , Estudios Prospectivos , Proyectos Piloto , Reproducibilidad de los Resultados , Abortivos Esteroideos/efectos adversos , Aborto Inducido/métodosRESUMEN
OBJECTIVE: To assess the risk difference of uterine rupture when using current mifepristone and misoprostol regimens for second-trimester abortion among individuals with prior cesarean birth compared with those without prior cesarean birth. DATA SOURCES: We searched the terms second trimester, induction, mifepristone, and abortion in PubMed, EMBASE, POPLINE, ClinicalTrials.gov , and Cochrane Library from inception until December 2022. METHODS OF STUDY SELECTION: We included randomized trials and observational studies including a mixed cohort, with and without uterine scar, of individuals at 14-28 weeks of gestation who used mifepristone and misoprostol to end a pregnancy or to manage a fetal death. We excluded case reports, narrative reviews, and studies not published in English. Two reviewers independently screened studies. TABULATION, INTEGRATION, AND RESULTS: Absolute risks with binomial CIs were calculated from pooled data. Using R software, we estimated total risk difference by the Mantel-Haenszel random-effects method without continuity correction. For studies with zero events, a continuity correction of 0.5 was applied for individual risk differences and plotted graphically with forest plots. Statistical heterogeneity was assessed with Higgins I2 statistics. Funnel plot assessed for publication bias. Of 198 articles identified, 22 met the inclusion criteria: seven randomized trials (n=923) and 15 observational studies (n=6,195). Uterine rupture risk with prior cesarean birth was 1.1% (10/874) (95% CI 0.6-2.1) and without prior cesarean birth was 0.01% (2/6,244) (95% CI 0.0-0.12). The risk difference was 1.23% (95% CI 0.46-2.00, I2 =0%). Of the 12 reported uterine ruptures, three resulted in hysterectomy. CONCLUSION: Uterine rupture with mifepristone and misoprostol use during second-trimester induction abortion is rare, with the risk increased to 1% in individuals with prior cesarean birth. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42022302626.
Asunto(s)
Aborto Inducido , Misoprostol , Rotura Uterina , Embarazo , Femenino , Humanos , Misoprostol/efectos adversos , Mifepristona/efectos adversos , Segundo Trimestre del Embarazo , Rotura Uterina/inducido químicamente , Rotura Uterina/epidemiología , Aborto Inducido/efectos adversos , Aborto Inducido/métodosRESUMEN
Importance: Misoprostol-alone regimens for abortion may be more effective than previously thought. Objective: To estimate the effectiveness of medication abortion with misoprostol alone among individuals self-managing their abortion. Design, Setting, and Participants: For this prospective observational cohort study of callers to safe abortion hotlines and accompaniment groups in Argentina, Nigeria, and Southeast Asia, participants were recruited between July 31, 2019, and October 1, 2020, prior to starting their medication abortion. Eligible participants were 13 years or older, had no contraindications to medication abortion, and were not currently bleeding. Participants completed a baseline and 2 follow-up surveys. The analysis was restricted to participants who reported using misoprostol alone and was performed between January 6, 2022 and September 8, 2023. Exposure: Self-managed medication abortion using misoprostol alone. Main Outcomes and Measures: The primary outcome was effectiveness, defined as participant self-report of complete abortion without procedural intervention, measured at 1 week and 3 weeks after taking misoprostol. Secondary outcomes included method safety, measured by self-report of experiencing warning signs (eg, heavy bleeding, pain, fever, discharge) indicative of a potential complication and by medical treatment (eg, blood transfusion, intravenous fluids, overnight hospital stay) indicative of a potential adverse event. Additional outcomes included length of bleeding and cramping, time to expulsion, and experience of adverse effects. Results: Among 1352 enrolled participants, 637 used misoprostol-alone regimens for abortion and were included in the analysis (591 [92.8%] from Nigeria, 45 [7.1%] from Southeast Asia, and 1 [0.2%] from Argentina; 384 [60.2%] aged 20-29 years; 317 [49.8%] with pregnancy durations <7 weeks and 205 [32.2%] with pregnancy durations between 7 and <9 weeks). At last follow-up after taking medication (median, 22 days; IQR, 21-26 days), 625 participants (98.1%; 95% CI, 96.7%-98.9%) had a complete abortion without procedural intervention. Potential adverse events were reported by 6 participants (0.9%; 95% CI, 0.4%-2.1%). Most participants experienced bleeding for less than 1 week (median, 4 days; IQR, 3-6 days) and expelled their pregnancy within 24 hours of starting the abortion process (median, 12 hours; IQR, 9-15 hours). Common side effects included nausea (335 participants [52.6%]), fever (232 [36.4%]), and diarrhea (181 [28.4%]). Conclusions and Relevance: The findings suggest that misoprostol alone is a highly effective method of pregnancy termination. Future research should explore strategies to maximize the effectiveness of misoprostol alone in clinical and nonclinical settings.
Asunto(s)
Aborto Inducido , Aborto Espontáneo , Misoprostol , Embarazo , Femenino , Humanos , Estudios Prospectivos , Mifepristona/efectos adversos , Aborto Inducido/métodos , Aborto Espontáneo/inducido químicamenteRESUMEN
OBJECTIVES: To evaluate the efficacy of combined mifepristone and misoprostol compared to misoprostol alone in outpatient medical treatment of first trimester miscarriage. Additionally, the study intends to compare the rate of complications, adverse effects, and treatment acceptability between groups. STUDY DESIGN: Single-center double-blind randomized placebo-controlled trial including women with diagnosis of missed first trimester miscarriage up to 9 weeks of gestation. RESULTS: Between April 2019 and November 2021, 216 women diagnosed with first trimester miscarriage up to 9 weeks of gestation were randomly assigned to mifepristone group or to misoprostol-alone group. Data from 105 women in mifepristone group and 103 women in misoprostol-alone group were analyzed, with no differences in baseline characteristics. The median time between medications (oral mifepristone/placebo and vaginal misoprostol) was nearly 43 h in both groups (p = 0.906). The median time to first follow-up was 2.6 weeks (IQR 1.0) in mifepristone group and 2.4 weeks (IQR 1.0) in misoprostol-alone group (p = 0.855). The overall success rate of medical treatment was significantly higher in the mifepristone-group comparing to misoprostol-alone group (94.3% vs. 82.5%, RR 1.14, 95% CI, 1.03-1.26; p = 0.008). Accordingly, the rate of surgical treatment was significantly lower in the mifepristone-group (5.7% vs.14.6%, RR 0.39, 95% CI, 0.16-0.97; p = 0.034). The composite complication rate was similar and lower than 4% in both groups. No case of complicated pelvic infection, hemodynamic instability or inpatient supportive treatment was reported. There were no significant differences in the rates of adverse events, median score for vaginal bleeding intensity or analgesics use. Despite the same median value, the score of abdominal pain intensity was significantly higher in the mifepristone-group (p = 0.011). In both groups, more than 65% of the women classified the treatment as "good" and 92% would recommend it to a friend on the same clinical situation. CONCLUSION: The mifepristone plus vaginal misoprostol combined treatment for medical resolution of first trimester miscarriage resulted in significant higher success rate and lower rate of surgical uterine evacuation comparing to misoprostol-alone treatment, with no relevant differences in adverse events or treatment acceptability.
Asunto(s)
Aborto Retenido , Aborto Espontáneo , Misoprostol , Femenino , Humanos , Embarazo , Mifepristona/efectos adversos , Misoprostol/efectos adversos , Primer Trimestre del EmbarazoRESUMEN
Randomized controlled trial comparing efficacy of a combination regime containing two cervical sensitizers (mifepristone + Foley's catheter) versus single agent mifepristone or Foley's catheter for labor induction in women attempting TOLAC at late third trimester with a dead fetus in utero. AIM: To compare efficacy and safety of a new combination regime comprising of two cervical sensitizers used simultaneously with single agents, for labor induction in women attempting TOLAC at ≥34 weeks' gestation with a dead fetus. METHOD: This was a multiarm randomized controlled trial (RCT) where participants received one of the three regimes-single agent oral Mifepristone 200 mg, intracervical Foley's catheter (16 Fr size, filled with 40 mL normal saline after intracervical instillation), and combination regime consisting of both used simultaneously. Number of women undergoing vaginal birth within 48 h of induction (VB48 ) was the primary outcome compared between groups. RESULTS: VB48 was higher in participants on combination regime in comparison to participants on Foley's catheter (54 vs. 42). Total vaginal births were higher in participants on combination regime compared to both single agents (58 vs. 48 and 44). Duration and dose of oxytocin augmentation was lower in participants on combination regime compared to both single agents. Induction birth interval was short in participants on combination regime compared to those on Foley's catheter. Maternal complications between groups were similar. CONCLUSION: Combination of cervical sensitizers for labor induction in late third trimester among women with dead fetus attempting TOLAC resulted in higher proportion of vaginal births and might reduce risk of scar dehiscence due to requirement of a lower dose of oxytocin for augmentation.
Asunto(s)
Oxitócicos , Embarazo , Femenino , Humanos , Oxitócicos/efectos adversos , Mifepristona/efectos adversos , Oxitocina , Tercer Trimestre del Embarazo , Trabajo de Parto Inducido/métodos , Catéteres , Feto , Maduración CervicalRESUMEN
Medications are known to affect the thyroid physiology and are a known cause of hypothyroidism. There is an ever-growing list of medications that affect the thyroid by 1 or more mechanisms. Mifepristone is presently used for the treatment of mild autonomous cortisol secretion (MACS). Hypothyroidism is not a known side effect of this medication. We present a 71-year-old woman with newly diagnosed impaired fasting glucose, dyslipidemia, and osteopenia presenting with a 3-year history of unintentional 15-pound weight gain (despite exercise and a good diet) and increased anxiety. Her physical examination was pertinent for mild lower extremity edema, easy bruising, and skin thinning. Workup revealed adrenocorticotropic hormone (ACTH)-independent MACS from bilateral micronodular hyperplasia of the adrenals. Since she was not a surgical candidate, medical management with mifepristone was chosen. While on mifepristone, she complained of excessive fatigue, a workup done revealed new-onset hypothyroidism. Given her symptoms and bloodwork, she was started on levothyroxine. After stopping mifepristone, she was biochemically and clinically euthyroid and was eventually off levothyroxine. The mechanism by which mifepristone induces hypothyroidism is unknown. Except for a multicenter case series suggesting that mifepristone increases thyroid hormone requirements in patients with central hypothyroidism, to the best of our knowledge, the literature on euthyroid patients developing hypothyroidism secondary to mifepristone is scarce. In conclusion, while the hypothyroidism seems reversible our case highlights the importance of getting baseline thyroid function tests (TFTs) and repeating them while on the medication. Treatment of hypothyroidism is based on symptoms and bloodwork.
Asunto(s)
Hipotiroidismo , Tiroxina , Femenino , Humanos , Anciano , Tiroxina/efectos adversos , Mifepristona/efectos adversos , Hipotiroidismo/inducido químicamente , Hipotiroidismo/tratamiento farmacológico , Hipotiroidismo/complicaciones , Pruebas de Función de la TiroidesRESUMEN
OBJECTIVES: This study aimed to review clinical practice outcomes of early pregnancy loss (EPL) medical management using mifepristone and misoprostol outside of a clinical trial setting. STUDY DESIGN: In this retrospective cohort study, we reviewed a deidentified database of patients who received mifepristone-misoprostol for EPL from May 2018 to May 2021 at our academic center-based clinic, which was a study site for a multicenter mifepristone-misoprostol EPL trial completed in March 2018. All patients received mifepristone 200 mg orally and misoprostol 800 mcg vaginally or buccally, with clinic follow-up typically scheduled within 1 week. The primary outcome was successful medical management, defined as management without the need for aspiration, and the secondary outcomes included additional interventions and indications, follow-up ultrasonography findings, and adverse events requiring treatment. RESULTS: We treated 90 patients with a median ultrasound-measured gestational size of 49 (range 30-80) days and median time from mifepristone to misoprostol of 24 (range 8-66) hours. Follow-up was completed in clinic by 80 (88.9%), completed remotely by five (5.6%), and not completed by five (5.6%) patients. Overall, 76 (95% CI 82.9%-96.0%) of 85 patients (89.4%) with follow-up were successfully managed without uterine aspiration. Eighty patients had initial follow-up ultrasonography interpreted as gestational sac expulsion; seven (8.8%) of these ultimately underwent aspiration, including one patient who had a previously undiagnosed cesarean scar ectopic pregnancy. Two patients had significant safety outcomes: one pelvic infection and one blood transfusion during aspiration in the patient with a cesarean scar ectopic pregnancy. CONCLUSIONS: Outside of a clinical trial setting, medical management of EPL with mifepristone and misoprostol remains effective and safe. IMPLICATIONS: Medical management of EPL with mifepristone and misoprostol is effective and safe outside of a clinical trial setting. A standardized protocol based on the best available clinical trial evidence can be used in clinical practice for the medical management of EPL.
Asunto(s)
Abortivos no Esteroideos , Abortivos Esteroideos , Aborto Inducido , Aborto Espontáneo , Misoprostol , Embarazo Ectópico , Embarazo , Femenino , Humanos , Mifepristona/efectos adversos , Misoprostol/efectos adversos , Abortivos no Esteroideos/efectos adversos , Abortivos Esteroideos/uso terapéutico , Estudios Retrospectivos , Cicatriz/inducido químicamente , Cicatriz/tratamiento farmacológico , Aborto Inducido/efectos adversos , Aborto Inducido/métodos , Embarazo Ectópico/diagnóstico , Estudios Multicéntricos como AsuntoRESUMEN
OBJECTIVES: This study aimed to evaluate the effectiveness and safety of medication abortion with misoprostol-only among patients treated by an abortion provider organization in the United States during the COVID-19 pandemic. STUDY DESIGN: We abstracted data from patients receiving misoprostol-only for abortion from December 2020 to December 2021. Two regimens were used, both allowing three to four doses of misoprostol 800 mcg every 3 hours but differing in the recommended administration routes (vaginal, buccal, or sublingual). We estimated the proportions of patients who had complete abortion and ongoing pregnancy in the two regimen groups in complete case analyses and after imputing missing outcomes based on pretreatment characteristics. We also estimated maximum effectiveness, assuming that all patients without known treatment failures had complete abortions. We tabulated serious adverse events. RESULTS: We ascertained abortion outcomes for 476 (52%) of the total 911 treated patients. Of the 476 patients, 389 (82%) had complete abortion confirmed by test or history, and 45 (9%) had ongoing pregnancies detected after the provision of treatment. These proportions did not differ significantly between the two regimen groups in adjusted complete case analyses (p > 0.44). The results of imputed analyses were similar. Of the total 911 patients, at most 90% (95% confidence interval 88%, 92%) had complete abortion, and at least 5% (95% confidence interval 4%, 7%) had ongoing pregnancy. Serious adverse events were reported in three patients (0.6% of 487 patients with data for this outcome). CONCLUSIONS: Our analysis suggests that the misoprostol-only regimens studied were safe and effective for most patients. Due to high loss to follow-up, observations from patients contacted after treatment likely somewhat underestimate true effectiveness. IMPLICATIONS: Medication abortion with misoprostol-only was safe and produced complete abortion in most patients with follow-up. If loss to follow-up is high, effectiveness observed by clinics may misestimate true treatment efficacy.
Asunto(s)
Abortivos no Esteroideos , Aborto Inducido , Aborto Espontáneo , COVID-19 , Misoprostol , Embarazo , Femenino , Humanos , Estados Unidos , Misoprostol/efectos adversos , Estudios Retrospectivos , Pandemias , COVID-19/etiología , Aborto Inducido/métodos , Aborto Espontáneo/etiología , Mifepristona/efectos adversos , Abortivos no Esteroideos/efectos adversosRESUMEN
OBJECTIVES: To assess the frequency of maternal adverse events associated with second trimester medical abortion using sequential mifepristone and misoprostol. STUDY DESIGN: Retrospective analysis of medical abortions 13 to 28 weeks gestation using sequential mifepristone and misoprostol in a single center from January 2008 to December 2018. The main outcomes evaluated were the nature and incidence of adverse procedural events and the impact of gestation upon these outcomes. RESULTS: During the study period, 1393 people underwent a medical abortion with sequential mifepristone and misoprostol. The median maternal age was 31 years (IQR 27-36 years) and 21.8% had at least one prior cesarean delivery. The median gestational age at abortion commencement was 19 weeks (IQR 17-21). The main adverse maternal events were complete or partial placental retention greater than 60 minutes triggering removal in the operating room (19%), maternal hemorrhage>1000 cc (4.3%), blood transfusion (1.7%), hospital readmission (1.4%), uterine rupture (0.29%) and hysterectomy (0.07%). There were significant reductions in placental retention rates with increasing gestational age (23.3% at 13-16 weeks gestation declining to 10.1% at>23 weeks gestation, p < 0.001). CONCLUSIONS: Serious adverse maternal events associated with second trimester medical abortion with sequential mifepristone-misoprostol are uncommon. IMPLICATIONS: Second trimester medical abortion with mifepristone and misoprostol is generally safe, however, on occasions serious complications may occur. All health care units providing a medical abortion service require the facilities and expertise to deal with these adverse events in a timely manner.
Asunto(s)
Abortivos no Esteroideos , Aborto Inducido , Misoprostol , Embarazo , Femenino , Humanos , Adulto , Lactante , Mifepristona/efectos adversos , Misoprostol/efectos adversos , Segundo Trimestre del Embarazo , Estudios Retrospectivos , Placenta , Aborto Inducido/efectos adversos , Abortivos no Esteroideos/efectos adversosRESUMEN
Importance: To date, no psychopharmacologic treatment has been found to be uniformly effective in veterans with posttraumatic stress disorder (PTSD); novel targets and approaches are needed to treat this disabling disorder. Objective: To examine whether treatment with the glucocorticoid receptor antagonist mifepristone yields a signal for clinical efficacy in male veterans with PTSD. Design, Setting, and Participants: This phase 2a, double-blind, parallel-group randomized clinical trial was conducted from November 19, 2012 (accrual started), through November 16, 2016 (final follow-up), within the US Department of Veterans Affairs. Participants were male veterans with chronic PTSD and a screening Clinician-Administered PTSD Scale score of 50 or higher. A total of 181 veterans consented to participation. Statistical analysis was conducted between August 2014 and May 2017. Interventions: Participants were randomized in a 1:1 ratio to mifepristone (600 mg) or matched placebo taken orally for 7 days. Main Outcomes and Measures: The clinical outcome was whether a veteran achieved a clinical response status (a reduction of ≥30% of total Clinician-Administered PTSD Scale score from baseline) at 4- and 12-week follow-up. On the basis of a binary statistical selection rule, a difference in the proportion of treatment vs control group responders of 15% would be a clinically relevant difference. Self-report measures of PTSD and associated symptoms were also obtained. Neuroendocrine outcomes and plasma levels of mifepristone were measured. Safety was assessed throughout the study. The primary analysis was based on a multiple imputation technique to address missing outcome data; thus, some participant numbers may not appear as whole numbers. Results: A total of 81 veterans were enrolled and randomized. Excluding 1 participant randomized in error, 80 were included in the modified intention-to-treat analysis (41 randomized to mifepristone and 39 to placebo). The mean (SD) age was 43.1 (13.7) years. A total of 15.6 (38.1%) in the mifepristone group and 12.1 (31.1%) in the placebo group were clinical responders at 4 weeks in the analysis using the multiple imputation technique. The group difference in the proportion of clinical responders (7.0%) was less than the predefined margin of 15% indicating signal for clinical efficacy. In an exploratory analysis, the difference in response to mifepristone vs placebo in the subgroup with no lifetime history of traumatic brain injury (TBI) (7.0 [50.0%] vs 3.0 [27.3%]; difference, 22.7%) exceeded the efficacy margin at 4 weeks and was sustained at 12 weeks. In contrast, in veterans with PTSD and lifetime TBI, the response rate to mifepristone was lower than placebo at 12 weeks (7.4 [27.4%] vs 13.5 [48.3%]; difference, -20.9%). Conclusions and Relevance: This study did not detect a signal for efficacy for mifepristone at 600 mg/d for 1 week in male veterans with chronic PTSD. Thus, this study does not support a phase 3 trial in this population. Future studies of mifepristone for the treatment of PTSD may be of interest in those without a history of TBI or in samples with a low base rate of lifetime head trauma. Trial Registration: ClinicalTrials.gov Identifier: NCT01946685.
Asunto(s)
Lesiones Traumáticas del Encéfalo , Trastornos por Estrés Postraumático , Veteranos , Estados Unidos , Humanos , Masculino , Adulto , Femenino , Mifepristona/efectos adversos , Trastornos por Estrés Postraumático/tratamiento farmacológico , Ceguera , GalopamiloRESUMEN
A single-dose, open-label, randomized, two-period crossover-design study was conducted to evaluate the bioequivalence of the reference and test formulations of mifepristone tablets. Each subject was randomized at the beginning to receive a 25-mg tablet of the test or the reference mifepristone under fasting conditions during the first period, then received the alternate formulation during the second period following a 2-week washout period. A validated high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method was used to determine the plasma concentrations of mifepristone and its two metabolites (RU42633 and RU42698). Fifty-two healthy subjects were enrolled in this trial, 50 of whom completed the study. The 90% confidence intervals for the log-transformed Cmax , AUC0-t , and AUC0-∞ fell within the accepted 80%-125% range. Throughout the study period, a total of 58 treatment-emergent adverse events were reported. No serious adverse event was observed. In conclusion, the test and reference mifepristone were bioequivalent and well tolerated under fasting conditions.