RESUMEN
OBJECTIVE: To evaluate the relationship between duration of labor during second-trimester medication abortion and adverse outcomes. METHODS: We conducted a retrospective cohort study including all individuals with a singleton gestation undergoing second-trimester medication abortion without evidence of advanced cervical dilation, rupture of membranes, or preterm labor at four centers. The primary exposure was duration of labor (ie, hours spent from receiving misoprostol to fetal expulsion). The primary outcome was composite morbidity , defined as uterine rupture, need for blood transfusion, clinical chorioamnionitis, intensive care unit admission, or need for readmission. We performed bivariate and multivariate negative binomial analyses. A post hoc subgroup analysis was performed to assess for the risk of the primary outcome by gestational age. We performed tests of homogeneity based on history of uterine scarring and parity. RESULTS: Six hundred eighty-one individuals were included. The median duration of labor was 11 hours (interquartile range 8-17 hours). One hundred thirty-one (19.2%) experienced the primary outcome. When duration of labor was evaluated continuously, a longer duration of labor was associated with an increased frequency of morbidity (adjusted ß=0.68, 95% CI, 0.32-1.04). When duration of labor was evaluated categorically, those experiencing the highest quartile of duration (ie, 17 hours or more) had a statistically higher risk for experiencing morbidity compared with individuals in all other quartiles (adjusted relative risk 1.99, 95% CI, 1.34-2.96). When we focused on components of the composite outcome, clinical chorioamnionitis was significantly different between those experiencing a longer duration and those experiencing a shorter duration of labor (26.2% vs 10.6%, P <.001). On subgroup analysis, gestational age was not associated with the risk of composite morbidity. Tests of homogeneity demonstrated no significant difference in the risk for morbidity among individuals with a history of uterine scarring or based on parity. CONCLUSION: Duration of labor was independently associated with risks for adverse maternal outcomes during second-trimester medication abortion, specifically clinical chorioamnionitis.
Asunto(s)
Aborto Inducido , Trabajo de Parto Inducido , Misoprostol , Segundo Trimestre del Embarazo , Humanos , Femenino , Embarazo , Estudios Retrospectivos , Adulto , Aborto Inducido/efectos adversos , Aborto Inducido/métodos , Trabajo de Parto Inducido/efectos adversos , Trabajo de Parto Inducido/métodos , Factores de Tiempo , Misoprostol/administración & dosificación , Misoprostol/efectos adversos , Corioamnionitis/epidemiología , Abortivos no Esteroideos/efectos adversos , Adulto Joven , Edad Gestacional , Rotura Uterina , Estudios de CohortesRESUMEN
BACKGROUND: However, misoprostol is often used to terminate a pregnancy, but it can also cause side effects. Isosorbide mononitrate (ISMN) can help the cervix mature by increasing the production of prostaglandin E2 and vasodilation. Considering that the results of studies in this field are contradictory, it is the purpose of this study to evaluate the efficacy and safety of vaginal ISMN plus misoprostol compared to misoprostol alone in the management of first- and second-trimester abortions. METHOD: The search process was conducted for MEDLINE through the PubMed interface, Scopus, Web-of-Science, Science Direct, the Cochrane Central Register of Controlled Trials (CENTRAL), Google Scholar, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform until November 10, 2023. Our assessment of bias was based on version 2 of the risk-of-bias tool (RoB2) for randomized trials and our level of evidence quality was determined by GRADE. Meta-analysis of all data was carried out using Review Manager (RevMan) version 5.1. RESULT: Seven randomized clinical trials were included in the systematic review and three in the meta-analysis, with mixed quality. The results of the meta-analysis revealed that in the second-trimester abortion, the inclusion of ISMN in conjunction with vaginal misoprostol results in a noteworthy reduction in the induction abortion interval, specifically by 4.21 h (95% CI: -7.45 to -0.97, P = 0.01). The addition of vaginal ISMN to misoprostol, compared to vaginal misoprostol alone, increased the odds of a completed abortion by 3.76 times. (95% CI: 1.08 to 13.15, P = 0.04). CONCLUSION: The findings of this study can offer valuable insights aimed at enhancing counseling and support for non-surgical methods of medication abortion within professional settings. Moreover, it improves the effectiveness of clinical treatment and reduces the occurrence of unnecessary surgical interventions in the abortion management protocol.
Asunto(s)
Abortivos no Esteroideos , Aborto Inducido , Dinitrato de Isosorbide , Misoprostol , Primer Trimestre del Embarazo , Segundo Trimestre del Embarazo , Humanos , Misoprostol/administración & dosificación , Misoprostol/uso terapéutico , Misoprostol/efectos adversos , Femenino , Embarazo , Dinitrato de Isosorbide/análogos & derivados , Dinitrato de Isosorbide/uso terapéutico , Dinitrato de Isosorbide/administración & dosificación , Aborto Inducido/métodos , Abortivos no Esteroideos/administración & dosificación , Abortivos no Esteroideos/uso terapéutico , Abortivos no Esteroideos/efectos adversos , Quimioterapia Combinada , Administración Intravaginal , Resultado del TratamientoAsunto(s)
Mifepristona , Misoprostol , Misoprostol/administración & dosificación , Misoprostol/efectos adversos , Humanos , Mifepristona/administración & dosificación , Estados Unidos , Femenino , Abortivos Esteroideos/administración & dosificación , Control de Medicamentos y Narcóticos/legislación & jurisprudencia , Embarazo , Abortivos no Esteroideos/administración & dosificación , Abortivos no Esteroideos/efectos adversos , Sustancias Controladas , Aborto Inducido/métodosRESUMEN
OBJECTIVE: To identify risk factors for readmission following methotrexate treatment for tubal pregnancy. METHODS: A retrospective study undertaken in two tertiary medical centers, including all individuals with medically treated tubal pregnancy (N = 511), between December 2009 and June 2021. Individuals with and without readmission following methotrexate treatment were compared. The primary outcome was the readmission rate. Secondary outcomes included the rate of post-discharge gynecological emergency department visits, tubal rupture rate, and the eventual need for surgical treatment. RESULTS: Readmission following methotrexate treatment occurred in 224/511 patients (43.8%). Most readmissions were due to abdominal pain or suspicion of treatment failure. Readmitted individuals were more likely to have a history of pelvic inflammatory disease and pretreatment serum human chorionic gonadotropin (hCG) >2000 mIU/mL. Both factors remained significantly associated with higher readmission rates in a logistic regression analysis (adjusted odds ratio [OR] 6.28, 95% confidence interval [CI] 1.30-30.45, and adjusted OR 2.73, 95% CI 1.83-4.07, respectively) after adjustment for age, endometriosis, tubal pathology, abdominal pain, and presence of yolk sac or embryo at diagnosis. A dose-dependent association was observed between pretreatment serum hCG levels and readmission rate (P < 0.001). Pretreatment hCG levels were also associated with tubal rupture and the eventual need for surgical treatment (P < 0.001 for both). A prediction model using hCG was not sufficiently accurate to predict readmission risk. CONCLUSION: Readmission following methotrexate treatment for tubal pregnancy was independently associated with previous pelvic inflammatory disease and pretreatment serum hCG levels. The latter was also associated with surgical intervention rate.
Asunto(s)
Abortivos no Esteroideos , Metotrexato , Readmisión del Paciente , Embarazo Tubario , Humanos , Femenino , Metotrexato/uso terapéutico , Metotrexato/efectos adversos , Readmisión del Paciente/estadística & datos numéricos , Embarazo , Adulto , Estudios Retrospectivos , Embarazo Tubario/tratamiento farmacológico , Embarazo Tubario/sangre , Embarazo Tubario/cirugía , Abortivos no Esteroideos/uso terapéutico , Abortivos no Esteroideos/efectos adversos , Factores de Riesgo , Gonadotropina Coriónica/sangre , Dolor Abdominal/etiología , Enfermedad Inflamatoria Pélvica/tratamiento farmacológico , Modelos LogísticosRESUMEN
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
OBJECTIVES: This study aimed to compare effectiveness and safety of cervical preparation with osmotic dilators plus same-day misoprostol or overnight mifepristone prior to dilation and evacuation (D&E). STUDY DESIGN: We conducted a retrospective cohort analysis of 664 patients initiating abortion between 18 and 22 weeks at an ambulatory health center. We abstracted medical record data from two consecutive 12-month periods in 2017 to 2019. All patients received overnight dilators plus: 600 mcg buccal misoprostol 90 minutes before D&E (period 1); 200 mg oral mifepristone at time of dilators (period 2). Our primary outcome was procedure time. We report frequency of patients experiencing any acute complication, defined as unplanned procedure (i.e., reaspiration, cervical laceration repair, uterine balloon tamponade) or hospital transfer and bleeding complications. RESULTS: We observed higher mean procedure time in the mifepristone group (9.7 ± 5.3 minutes vs 7.9 ± 4.4, p = 0.004). After adjusting for race, ethnicity, insurance, body mass index, parity, prior cesarean, prior uterine surgery, gestational age, provider, trainee participation, and long-acting reversible contraception initiation, the difference remained statistically significant (relative change 1.09, 95% CI 1.01, 1.17) but failed to reach our threshold for clinical significance. The use of additional misoprostol was more common in the mifepristone group, but the use of an additional set of dilators was not different between groups. Acute complications occurred at a frequency of 4.1% in misoprostol group and 4.3% in mifepristone group (p = 0.90). CONCLUSIONS: We found procedure time to be longer with adjunctive mifepristone compared to misoprostol; however, this difference is unlikely to be clinically meaningful. Furthermore, the frequency of acute complications was similar between groups. IMPLICATIONS: Overnight mifepristone at the time of cervical dilator placement is a safe and effective alternative to adjuvant same-day misoprostol for cervical preparation prior to D&E and may offer benefits for clinic flow and patient experience.
Asunto(s)
Abortivos no Esteroideos , Misoprostol , Embarazo , Femenino , Humanos , Misoprostol/efectos adversos , Mifepristona , Dilatación , Abortivos no Esteroideos/efectos adversos , Estudios Retrospectivos , Segundo Trimestre del EmbarazoRESUMEN
OBJECTIVES: To evaluate the safety of current guidelines on methotrexate (MTX) administration in women with pregnancy of unknown location (PUL) who are considered to have a high risk of underlying ectopic pregnancy (EP), and to investigate whether implementation of these guidelines would result in inadvertent exposure to MTX of viable intrauterine pregnancies (IUPs). METHODS: This was a retrospective observational study of consecutive clinically stable women who were classified with PUL at the early pregnancy unit of Nepean Hospital, Sydney, Australia, between 2007 and 2021. PUL was defined as a positive pregnancy test in the absence of signs of IUP or EP on transvaginal ultrasound. Patients with a PUL that behaved biochemically like an EP, but for which the location of pregnancy was not confirmed on ultrasound, were eligible for MTX to minimize the risk of subsequent tubal rupture. Criteria discussed in the guidelines of the American College of Obstetricians and Gynecologists (ACOG), American Society for Reproductive Medicine (ASRM), Royal College of Obstetricians and Gynaecologists (RCOG) and National Institute for Health and Care Excellence (NICE) were applied to the PUL database. The number of patients eligible to receive MTX and the number with an underlying viable IUP who would be inadvertently prescribed MTX were calculated. RESULTS: A total of 816 women with PUL were reviewed, of whom 724 had complete data and were included in the final analysis. Six patients had persistent PUL and the remaining 718 had a diagnosis of viable IUP, non-viable IUP, EP or failed PUL. According to the ACOG, ASRM, RCOG and NICE guidelines, the rate of MTX administration among patients with PUL would have been 2.76%, 4.56%, 0.41% and 35.36%, respectively. However, no persistent PUL would have received MTX according to the ACOG, ASRM and RCOG protocols (the NICE protocol identified patients with persistent PUL with a sensitivity of 100%), and the majority of MTX treatments were unnecessary because those patients were later classified as having non-viable IUP or failed PUL. Application of ACOG and ASRM guidance could result theoretically in inadvertent MTX administration to women with an underlying viable IUP at a rate of 4.1/1000 (3/724). CONCLUSIONS: Current guidelines used to predict high risk of EP in the PUL population lead to inadvertent MTX administration to women with an underlying viable IUP. These guidelines should be used wisely to ensure that no wanted pregnancy is exposed to MTX. Women with PUL should be monitored carefully, and MTX should be used judiciously when the location of pregnancy is yet to be confirmed. © 2024 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.
Asunto(s)
Abortivos no Esteroideos , Metotrexato , Embarazo Ectópico , Humanos , Femenino , Metotrexato/efectos adversos , Metotrexato/administración & dosificación , Embarazo , Estudios Retrospectivos , Embarazo Ectópico/diagnóstico por imagen , Embarazo Ectópico/tratamiento farmacológico , Adulto , Abortivos no Esteroideos/efectos adversos , Abortivos no Esteroideos/administración & dosificación , Guías de Práctica Clínica como Asunto , AustraliaRESUMEN
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
BACKGROUND: Cases of second trimester pregnancy loss can be treated either pharmacologically or by surgical evacuation. Misoprostol, an E1-prostaglandin analog, is used to facilitate the evacuation of the uterus. OBJECTIVES: To determine the risk factors associated with patients who were treated with five or more repeated doses of misoprostol. METHODS: We conducted a retrospective study of patients treated with vaginal misoprostol at our institution between December 2016 and October 2021 for second trimester pregnancy loss. RESULTS: In total, 114 patients were eligible for analysis; 83 were treated with < 5 doses and 31 with ≥ 5. We recorded each case in which repeated doses were administered, irrespective of predetermined conditions such as gravidity, parity, maternal age, or gestational age. Moreover, cases of five or more misoprostol dosing were not associated with an increased complications rate, except for the increased duration of hospitalization (3.1 vs. 2.2 days, P-value < 0.01). CONCLUSIONS: Repeated dosing could not be predicted before treatment among those treated with vaginally administered misoprostol for second trimester pregnancy loss. However, low complication rates of repeated dosing may reassure both physicians and patients regarding safety, efficacy, and future fertility.
Asunto(s)
Abortivos no Esteroideos , Aborto Inducido , Misoprostol , Embarazo , Femenino , Humanos , Misoprostol/efectos adversos , Segundo Trimestre del Embarazo , Abortivos no Esteroideos/efectos adversos , Estudios Retrospectivos , Hospitales de EnseñanzaRESUMEN
OBJECTIVE: The availability of reliable and inexpensive markers that can be used to determine the risk of rupture during methotrexate (MTX) treatment in ectopic pregnancies (EPs) is considerable. The aim of the present study is to investigate the role of systemic inflammatory markers such as leukocytes (or white blood cells, WBCs), the neutrophil-to-lymphocyte ratio (NLR), and platelet distribution width (PDW), which are among the parameters of the complete blood count (CBC), in the prediction of rupture of EPs under MTX treatment. MATERIALS AND METHODS: A total of 161 patients with tubal EP who underwent a single-dose methotrexate (MTX) protocol were retrospectively analyzed, and the control group (n = 83) included patients cured by MTX, while the ruptured group (n = 78) included patients who were operated on for tubal rupture during the MTX treatment. The features of EP, beta-human chorionic gonadotropin (ß-hCG) levels, sonographic findings, and CBC-derived markers such as WBC, NLR, and PDW, were investigated by comparing both groups. RESULTS: The NLR was found to be higher in the ruptured group, of 2.92 ± 0.86%, and significantly lower in the control group, of 2.09 ± 0.6%. Similarly, the PDW was higher (51 ± 9%) in the ruptured group, and it was significantly lower a (47 ± 13%) in the control group (p < 0.05). Other CBC parameters were similar in both groups (p > 0.05). CONCLUSION: Systemic inflammation markers derived from CBC can be easily applied to predict the risk of tubal rupture in Eps, since the CBC is an inexpensive and easy-to-apply test, which is first requested from each patient during hospitalization.
OBJETIVO: A disponibilidade de marcadores confiáveis e baratos que podem ser usados para determinar o risco de ruptura durante o tratamento com metotrexato (MTX) em gestações ectópicas (GEs) é considerável. O objetivo do presente estudo é investigar o papel de marcadores inflamatórios sistêmicos, como leucócitos (ou glóbulos brancos, glóbulos brancos), a relação neutrófilo-linfócito (NLR) e largura de distribuição de plaquetas (PDW), que estão entre os parâmetros do hemograma completo (hemograma), na predição de ruptura de PEs sob tratamento com MTX. MATERIAIS E MéTODOS: Foram analisados retrospectivamente 161 pacientes com EP tubária submetidas a protocolo de dose única de metotrexato (MTX), sendo que o grupo controle (n = 83) incluiu pacientes curadas com MTX, enquanto o grupo roto (n = 78) incluíram pacientes operadas por ruptura tubária durante o tratamento com MTX. As características de EP, beta-gonadotrofina coriônica humana (ß-hCG), achados ultrassonográficos e marcadores derivados de CBC, como WBC, NLR e PDW, foram investigados comparando os dois grupos. RESULTADOS: A RNL foi maior no grupo roto, de 2,92 ± 0,86%, e significativamente menor no grupo controle, de 2,09 ± 0,6%. Da mesma forma, o PDW foi maior (51 ± 9%) no grupo roto, e foi significativamente menor a (47 ± 13%) no grupo controle (p < 0,05). Outros parâmetros do hemograma foram semelhantes em ambos os grupos (p > 0,05). CONCLUSãO: Marcadores inflamatórios sistêmicos derivados do hemograma podem ser facilmente aplicados para predizer o risco de ruptura tubária na Eps, uma vez que o hemograma é um exame de baixo custo e fácil aplicação, solicitado primeiramente a cada paciente durante a internação.
Asunto(s)
Abortivos no Esteroideos , Embarazo Ectópico , Embarazo Tubario , Embarazo , Femenino , Humanos , Metotrexato/efectos adversos , Estudios Retrospectivos , Abortivos no Esteroideos/efectos adversos , Embarazo Tubario/tratamiento farmacológico , Embarazo Ectópico/tratamiento farmacológico , Recuento de Células SanguíneasRESUMEN
OBJECTIVES: This study aimed to update our 2019 systematic review of data on the effectiveness and safety of misoprostol-only for first-trimester abortion. STUDY DESIGN: We searched PubMed on December 18, 2022, to find published articles describing the outcomes of treatment with misoprostol-only for abortion of viable intrauterine pregnancy at ≤91 days of gestation. From each article identified, two authors independently abstracted relevant data about each group of patients treated with a distinct regimen. We assessed the risk of bias using four defined indicators. We estimated the proportion of patients with treatment failure using meta-analytic methods as well as the proportion hospitalized or transfused after treatment. We examined associations between treatment failure and selected characteristics of the groups. RESULTS: We identified 49 papers with 66 groups that collectively included 16,354 evaluable patients, of whom 2960 (meta-analytic estimate 15%, 95% CI 12%, 19%) had treatment failures. Of 9228 patients assessed for ongoing pregnancy after treatment, 521 (meta-analytic estimate 6%, 95% CI 5%, 8%) had that condition. Failure risk was significantly associated with misoprostol dose, the total allowed number of doses, the maximum duration of dosing, and certain indicators of risk of bias. Among 11,007 patients allowed to take at least three misoprostol doses, the first consisting of misoprostol 800 mcg administered vaginally, sublingually, or buccally, the meta-analytic estimate of the failure risk was 11% (95% CI 8%, 14%). At most, 0.2% of 15,679 evaluable patients were hospitalized or received transfusions. CONCLUSIONS: Although some studies in this updated review were adjudicated to have a high risk of bias, the results continue to support the key conclusion of our 2019 analysis: misoprostol-only is effective and safe for the termination of first-trimester intrauterine pregnancy. IMPLICATIONS: Misoprostol-only is a safe and effective option for medication abortion in the first trimester if mifepristone is unavailable or inaccessible.
Asunto(s)
Abortivos no Esteroideos , Abortivos , Aborto Inducido , Misoprostol , Embarazo , Femenino , Humanos , Misoprostol/efectos adversos , Primer Trimestre del Embarazo , Mifepristona , Aborto Inducido/métodos , Abortivos no Esteroideos/efectos adversosRESUMEN
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.
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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
OBJECTIVE: Ectopic pregnancy (EP) rupture after methotrexate (MTX) treatment can have severe consequences. We examined clinical characteristics and beta-hCG trends that may predict EP rupture after MTX treatment. STUDY DESIGN: In this 10-year retrospective study of 277 women with an EP, we compared clinical, sonographic and beta-hCG trends, before and after MTX treatment, between those who did and did not have an EP rupture after MTX treatment. RESULTS: EP rupture was diagnosed in 41 women (15.1%) within 25 days of MTX treatment, and was correlated with higher parity and advanced pregnancy age: 2(0-5) vs. 1(0-6), P = 0.027 and 6.6(4.2-9.8) vs. 6.1(4-9.5), P = 0.045. EP rupture was also correlated with higher beta-hCG levels on days 0, 4 and 7 of MTX treatment: (2063 vs. 920 mIU/ml), (3221 vs. 921 mIU/ml) and (2368 vs. 703 mIU/ml), respectively, P < 0.001, for all. An increase of beta-hCG by>14% during days 0-4 showed a sensitivity of 71.4% CI 95% [55.4%-84.3%] and a specificity of 67.5% CI 95% [61.1%-73.6%] for predicting EP rupture after MTX treatment. Beta-hCG > 910 mIU/ml on day 0 showed a sensitivity of 80.9% CI 95% [66.7%-90.8%] and a specificity of 70.4% CI 95% [64.1%-76.3%] for predicting EP rupture after MTX treatment. A beta-hCG increase by>14% during days 0-4, and a beta-hCG value > 910 mUI/mL on day 0 were associated with increased risks of EP rupture after MTX treatment; the odds ratios were 6.4 and 10.5, respectively. Odds ratios were 8.06 [CI 95% (3.70-17.56)], P < 0.001 for every percent rise in beta-hCG during days 0-4; 1.37 [CI 95% (1.06-1.86)], P = 0.046 for every week change in gestational age; and 1.001 [CI 95% (1.000-1.001)], P < 0.001 for every unit rise in beta-hCG at day 0. CONCLUSION: Beta-hCG > 910 mIU/ml at day 0, a rise in beta-hCG by>14% during days 0-4, and more advanced gestational age were associated with EP rupture after MTX treatment.
Asunto(s)
Abortivos no Esteroideos , Embarazo Ectópico , Embarazo , Femenino , Humanos , Preescolar , Metotrexato/efectos adversos , Estudios Retrospectivos , Abortivos no Esteroideos/efectos adversos , Embarazo Ectópico/tratamiento farmacológico , Embarazo Ectópico/diagnóstico , Factores de Riesgo , Gonadotropina Coriónica Humana de Subunidad betaRESUMEN
BACKGROUND: Methotrexate is an anticancer drug from the antimetabolite class. It is also used in gynecology and obstetrics for the medical treatment of ectopic pregnancies. Low-dose methotrexate-induced adverse toxic effects are rare. We report a case of toxic effect associated with severe renal insufficiency induced by LD-MTX (Low-Dose Methotrexate) for ectopic pregnancy. CASE PRESENTATION: A 46-year-old Chinese woman was in an operation for an ectopic pregnancy of tubal interstitial pregnancy. The embryo villus was so little that we were not sure if it was evacuated, then it was followed with 50 mg methotrexate injection of intramuscular adjacent the uterine horn in the operation. 48 hour later after injection the patient presented with renal failure. The personalized genetic testing showed that MTHFR (677C > T) and ABCB1 (3435T > C) were detected. Gradually, the symptoms improved after calcium leucovorin (CF) rescue, continuous renal replacement therapy (CRRT), promoting blood system regeneration, and multiple supportive treatments. CONCLUSIONS: When toxic effects are suspected, detecting the polymorphisms of an MTHFR gene and monitoring MTX concentration in blood could assist us to formulate individualized and active treatments. The management should be multidisciplinary and as much as possible within an intensive care unit.
Asunto(s)
Abortivos no Esteroideos , Embarazo Ectópico , Embarazo , Femenino , Humanos , Persona de Mediana Edad , Metotrexato/uso terapéutico , Abortivos no Esteroideos/efectos adversos , Embarazo Ectópico/tratamiento farmacológico , Polimorfismo Genético , LeucovorinaRESUMEN
Methotrexate administration for the treatment of tubal ectopic pregnancies has been shown to cause tubal mass enlargement. Our hypothesis was that, by administrating Methotrexate, a local necrotic reaction occurs, leading to hematoma formation and eventually fallopian tube rupture. Salpingectomy specimens were collected, analysed and divided into three equal groups: patients who received Methotrexate but who ultimately failed medical treatment, patients who had a viable ectopic pregnancy and patients with a self-resolving ectopic pregnancy that were operated due to other medical indications. The specimens were dyed using the Cleaved Caspase-3 (Asp175) Rabbit mA. Specimens were divided into three equal groups and analysed. The patients in self-resolving ectopic pregnancy group were older and had more pregnancies. Rates of apoptosis were found to be less than 1% per slide. Necrosis was not evident in any of the pathological specimens. It seems Methotrexate administration does not lead to a significant tubal necrotic reaction. Further studies are required.
Asunto(s)
Abortivos no Esteroideos , Embarazo Ectópico , Embarazo , Humanos , Femenino , Animales , Conejos , Metotrexato/efectos adversos , Abortivos no Esteroideos/efectos adversos , Embarazo Ectópico/inducido químicamente , Embarazo Ectópico/cirugía , Necrosis/inducido químicamente , ApoptosisRESUMEN
OBJECTIVES: We conducted a pilot study to evaluate a single dose of letrozole 30 mg prior to misoprostol 800 mcg buccally for medication abortion STUDY DESIGN: We enrolled 40 participants seeking medication abortion up to 63 days' gestation at a site in Salt Lake City, UT. Participants received a single dose of letrozole 30 mg in-clinic followed 2 days later by misoprostol 800 mcg buccally at home. They took a second dose of misoprostol if they had no bleeding within 24 hours of the first. Participants returned 7 to 10 days later for assessment of abortion outcome and side effects RESULTS: Thirty-seven participants (93%) returned for follow-up and 2 (5%) went to another facility from which research staff obtained outcome data. Three-fourths (29/39, 74%, 95% CI: 60%-89%) had a complete abortion; 4 (10%, 95% CI: 0.3%-20%) had an incomplete abortion and opted for aspiration, and 6 (15%, 95% CI: 4%-27%) had an ongoing pregnancy. All subjects with follow-up reported taking the first dose of misoprostol. Ten (27%) took the second dose as well; only three did so due to no bleeding. Nineteen participants (51%) reported side effects after letrozole prior to misoprostol and two people (5%) rated these effects as severe. Side effects following misoprostol occurred in 33 participants (89%) and were as expected based on previous literature. No serious adverse events were reported CONCLUSION: A single dose of letrozole 30 mg followed by misoprostol had lower than desirable efficacy and does not warrant further study. IMPLICATIONS: A single dose of letrozole does not appear to be an effective adjunct to misoprostol for medication abortion.
Asunto(s)
Abortivos no Esteroideos , Aborto Inducido , Misoprostol , Embarazo , Femenino , Humanos , Misoprostol/efectos adversos , Letrozol , Proyectos Piloto , Abortivos no Esteroideos/efectos adversos , Aborto Inducido/efectos adversos , Mifepristona/efectos adversos , Administración IntravaginalRESUMEN
The aim of this study was establishment of an UHPLC-QqQ-MS/MS method for the deter-mination of misoprostol acid in biological specimens in cases of pharmacological abortions. Forensic toxicological examination was performed in three different biological samples (whole blood, placenta and fetal liver). The validation parameters of the method were as follows: limit of detection: 25 pg/mL; limit of quantification: 50 pg/mL, coefficient of determination: >0.999 (R2), intra- and interday accuracy and precision: not greater than 13.7%. The recovery and matrix effect were in the range of 88.3−95.1% and from −11.7 to −4.9%, respectively. Toxicological analysis of the mother's blood (collected two days after pregnancy termination) did not reveal any abortifacients; however, misoprostol acid was found in the placenta (793 pg/g) and fetal liver (309 pg/g). The second case involved a fetus found near a garbage container. The concentration of misoprostol acid in the placenta was 2332 pg/g. In the presented study, an extensive literature review of misoprostol pharmacokinetics studies was performed. To our knowledge, the UHPLC-QqQ-MS/MS technique presented in this paper is the first quantitative method applied for forensic toxicological purposes. In addition, postmortem concentrations of misoprostol acid in miscarried fetuses due to illegal abortions were reported for the first time.