RESUMEN
Mifepristone was recently approved in the United States. Regimens with shorter intervals may be more acceptable. The objective of this study was to determine whether the oral route of misoprostol was as effective as the vaginal route of misoprostol 1 day after mifepristone. A prospective, open-labeled, randomized trial of healthy adult women up to 63 days pregnant and wanting a medical abortion were randomized to use either two doses of oral misoprostol 400 microg taken 2 h apart or misoprostol 800 microg vaginally. Women self-administered misoprostol 1 day after taking one-third of the standard dose of mifepristone (200 mg) orally. Women then returned to the clinic up to 5 days later for a repeat sonogram evaluation. A dose of vaginal misoprostol was administered to women with a continuing pregnancy who then returned 1 day later to Day 15. The primary outcome measures were a complete medical abortion by the first or by the second follow-up visits. Surgical intervention was indicated for continuing pregnancy at the second follow-up visit, excessive bleeding, or persistent products of conception 5 weeks later. One thousand one hundred sixty-eight women were enrolled. Of the 1144 (98%) women who complied with their random assignment, two oral doses of misoprostol (800 microg total) were 90% effective at inducing an abortion by the first follow-up visit, compared with one dose of misoprostol by vagina of 97% (chi(2) = 23.95, p = 0.001). By the second follow-up visit, the complete abortion rate was 95% for oral misoprostol and 99% for vaginal misoprostol (chi(2) = 21.76, p = 0.001). There were minimal differences in side effects. Women preferred the oral route. The trial demonstrated that although two doses of oral misoprostol were effective, the vaginal misoprostol was more effective at inducing an early medical abortion at 1 day after low-dose mifepristone, and the regimen could be extended to 63 days gestation.
Asunto(s)
Abortivos no Esteroideos/administración & dosificación , Abortivos Esteroideos/administración & dosificación , Aborto Inducido , Mifepristona/administración & dosificación , Misoprostol/administración & dosificación , Abortivos no Esteroideos/efectos adversos , Abortivos Esteroideos/efectos adversos , Administración Intravaginal , Administración Oral , Adolescente , Adulto , Quimioterapia Combinada , Femenino , Humanos , Mifepristona/efectos adversos , Misoprostol/efectos adversos , Embarazo , Estudios Prospectivos , Análisis de Regresión , Resultado del TratamientoRESUMEN
The study was conducted to determine whether the administration of mifepristone followed by vaginal misoprostol can induce an abortion in early pregnancy when no gestational sac is present on sonogram. This report presents a prospective, pilot study of 30 healthy adult women, pregnant and seeking an abortion, and with no gestational sac on sonogram. All women had a baseline serum chorionic gonadotropin (hCG) level measured prior to using mifepristone 200 mg orally followed by misoprostol 800 mcg vaginally 48 h later, and then returned up to 4 days later for a repeat sonogram and serum hCG level. Women with initial hCG levels > 2000 IU/L were evaluated for ectopic pregnancy. At the first follow-up visit, if the hCG decreased by >50%, the women were followed with home pregnancy (25 IU/L) tests weekly until negative. If the levels did not decrease by 50%, a second dose of misoprostol was given. Surgical intervention was indicated for persistent hCG levels or excessive bleeding. Of the 30 women enrolled, the mean number of days of amenorrhea was 40 (SD 9) days. Two women had surgical intervention for continuing pregnancy, 2 had ectopic pregnancies, and 1 was lost to follow-up. Complete medical abortions occurred in 25/30 (88%) women, but when recalculated, in 25/27 (93%) women who completed the protocol and who did not have an ectopic pregnancy. There was 1 adverse event in a woman with an ongoing pregnancy who then received methotrexate. She was hospitalized a day later with a complicated pelvic infection and likely methotrexate-induced pneumonitis. Twenty-three women had a decrease in hCG at first follow-up visit of >50%. All 27 women who completed the protocol found the overall regimen acceptable. Mifepristone followed at 48 h by vaginal misoprostol were effective and acceptable in inducing an abortion in very early pregnancy. There may be a higher incidence of failure in very early pregnancies. Documentation of a complete abortion by hCG level is necessary to ensure the pregnancy is neither ongoing nor ectopic.
Asunto(s)
Abortivos no Esteroideos/administración & dosificación , Abortivos Esteroideos/administración & dosificación , Aborto Inducido/métodos , Mifepristona/administración & dosificación , Misoprostol/administración & dosificación , Administración Intravaginal , Administración Oral , Adulto , Gonadotropina Coriónica/sangre , Femenino , Edad Gestacional , Humanos , Satisfacción del Paciente , Proyectos Piloto , Embarazo , Primer Trimestre del Embarazo , Embarazo Ectópico/diagnóstico , Estudios Prospectivos , Ultrasonografía , Útero/diagnóstico por imagenRESUMEN
OBJECTIVE: To characterize women who underwent curettage after medical abortion with mifepristone and vaginal misoprostol, to describe when curettage occurred and the reasons for the intervention, and to categorize the indications for curettage according to a simple classification schema. METHODS: These analyses used data from two multisite, randomized controlled trials sponsored by Abortion Rights Mobilization. In the first study, women pregnant less than 63 days received 200 mg of mifepristone and 800 microg of vaginal misoprostol to use 48 hours after taking mifepristone. In the second study, women pregnant less than 56 days were randomly assigned to insert vaginal misoprostol at 1, 2, or 3 days after mifepristone administration. Case report forms and clinical case notes of all women who underwent curettage were examined. RESULTS: Of the 4393 women enrolled in both studies, 116 (2.6%, 95% confidence interval 2.1%, 3.1%) curettages were identified. The gestational age and a history of prior elective abortion were associated with the rate of curettage. The distribution of indications for curettage included bleeding, 61 (53%); continuing pregnancy, 17 (15%); patient request, 36 (31%); and indeterminate, 2 (1.7%). The timing of curettage differed by the indication and scheduled interval between study visits. The distribution of the timing was bimodal. One subset of women, 44 (38%), underwent curettage in the first study week and another subset, 43 (37%), during weeks 3-5. CONCLUSION: Curettage after medical abortion with mifepristone and vaginal misoprostol is rare. At least one half of the curettages were performed for persistent bleeding several weeks after treatment. Both acute heavy bleeding and continuing pregnancy are extremely rare.
Asunto(s)
Abortivos no Esteroideos , Abortivos Esteroideos , Aborto Inducido , Legrado/estadística & datos numéricos , Mifepristona , Misoprostol , Adolescente , Adulto , Femenino , Humanos , Estudios Multicéntricos como Asunto , Embarazo , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de TiempoRESUMEN
Approximately one-third of pregnant teenagers in the U.S. choose abortion. This prospective study evaluated whether medical abortion with mifepristone and misoprostol is physically and emotionally acceptable in adolescents. Adolescents 14- to 17-years-old, with pregnancies < or =56 days gestation, and seeking abortion services with parental consent from at least one parent were enrolled. Mifepristone (200 mg) was administered, followed 2 days later by 800 microg of misoprostol administered vaginally. Follow-up visit occurred on Day 4-8 to confirm abortion completion. Questionnaires regarding acceptability of the procedure as well as emotional coping were administered at the initial visit, at the follow-up visit, and by phone at 4 weeks postabortion. All 28 adolescents had complete medical abortions without complications or surgical intervention, and five minors did not require misoprostol. At the Day 4-8 follow-up visit, 75% of teens found the procedure acceptable, and that increased to 96% by the 4-week visit. Although 57% reported stress and 43% reported fear initially, by 4 weeks postabortion only 21% of the teens reported stress, and 8% were still experiencing fear. In addition, the minors' satisfaction with their abortion decision increased from 43% to 79% by 4 weeks postabortion. Medical abortion with mifepristone and misoprostol was highly effective and well tolerated, physically and emotionally, by adolescents in our sample. A larger clinical trial is needed to generalize these findings to other adolescent populations seeking medical abortion services.
Asunto(s)
Abortivos Esteroideos/administración & dosificación , Anticonceptivos Poscoito/administración & dosificación , Mifepristona/uso terapéutico , Abortivos no Esteroideos/administración & dosificación , Aborto Inducido , Adolescente , Esquema de Medicación , Femenino , Humanos , New York , Aceptación de la Atención de Salud , Embarazo , Estudios Prospectivos , Estrés Fisiológico/psicología , Encuestas y CuestionariosRESUMEN
Primary care clinicians who provide comprehensive reproductive heath care can now offer patients mifepristone (Mifeprex) as an abortifacient option. Clinicians, however, must first determine if the state in which they practice has regulations specifying who can perform abortions and dispense drugs, and they must consider clinical office zoning ordinances, staffing, public relations issues, and reimbursement. This article discusses the pharmacology of mifepristone and misoprostol, professional considerations, and how to prevent and manage adverse effects and complications of medical abortion.
Asunto(s)
Abortivos Esteroideos , Aborto Inducido/legislación & jurisprudencia , Aborto Inducido/métodos , Mifepristona , Enfermeras Practicantes/organización & administración , Atención Primaria de Salud/organización & administración , Atención Primaria de Salud/normas , Autonomía Profesional , Aborto Inducido/efectos adversos , Aborto Inducido/enfermería , Protocolos Clínicos , Prescripciones de Medicamentos , Medicina Basada en la Evidencia , Femenino , Humanos , Enfermeras Practicantes/educación , Mecanismo de Reembolso/legislación & jurisprudencia , Estados UnidosRESUMEN
CONTEXT: The conventional timing of misoprostol administration after mifepristone for medical abortion is 2 days, but more flexible intervals, which may make the regimen more convenient, have not been studied. OBJECTIVE: To determine whether vaginal misoprostol administered 1, 2, or 3 days after mifepristone influences safety or effectiveness for abortion at up to 56 days' gestation. DESIGN: Prospective, randomized, open-label trial conducted from March 1998 to June 1999. SETTING: Sixteen US primary care and referral abortion facilities. PATIENTS: A total of 2295 healthy patients aged 18 years or older who were 56 or fewer days pregnant. Forty (1.7%) were lost to follow-up. INTERVENTIONS: Patients received 200 mg of oral mifepristone and were randomly assigned to self-administer 800 microg of vaginal misoprostol at home 1 (n = 745), 2 (n = 778), or 3 (n = 772) days later. Women returned to the clinic up to 8 days after mifepristone for ultrasonographic evaluation. A second dose of misoprostol was administered if the abortion was not complete. Patients with continuing pregnancy, excessive bleeding, or retained pregnancy tissue 5 weeks later received an aspiration curettage. MAIN OUTCOME MEASURES: Effectiveness of the procedure (ie, a complete medical abortion without surgical intervention), adverse effects, acceptability of the procedure based on patient questionnaires, reasons for surgical intervention, and adverse outcomes, compared among the study groups. RESULTS: Of the 2255 women completing follow-up, complete medical abortion rates were 98% (95% confidence interval [CI], 97%-99%) among those using misoprostol after 1 day, 98% (95% CI, 97%-99%) for those using misoprostol after 2 days, and 96% (95% CI, 95%-97%) among those using misoprostol after 3 days. Fifty-five subjects aborted before taking misoprostol, 9 had early surgery, and 103 did not take misoprostol on their assigned day. No blood transfusions were required. Cramping and nausea were the most common adverse effects reported, with similar percentages of patients in all 3 groups reporting such effects. Thirteen unexpected or serious adverse events occurred: 6 in those using misoprostol after 1 day; 4 in those using it after 2 days; and 3 in those using it after 3 days. Nearly all women (>90%) found the procedure to be acceptable. CONCLUSIONS: Our results suggest that vaginal misoprostol, 800 microg, can be used from 1 to 3 days after mifepristone, 200 mg, for early medical abortion, and need not be administered strictly 48 hours after mifepristone. JAMA. 2000;284:1948-1953.
Asunto(s)
Abortivos/administración & dosificación , Aborto Inducido/métodos , Mifepristona/uso terapéutico , Misoprostol/administración & dosificación , Abortivos/uso terapéutico , Administración Intravaginal , Adulto , Esquema de Medicación , Quimioterapia Combinada , Femenino , Humanos , Misoprostol/uso terapéutico , Embarazo , Estudios Prospectivos , Factores de TiempoRESUMEN
The clinical assessment of patients who request early medical abortion includes confirmation of the diagnosis of pregnancy and estimation of gestational age. Accurate gestational dating is essential, because the efficacies of medical abortion regimens decline as pregnancy advances. Whereas medical abortion researchers in the United States have relied on routine ultrasonography for gestational dating, abortion providers experienced with mifepristone and prostaglandin regimens outside the United States have reported high efficacy and safety primarily with clinical dating parameters. Diligent follow-up of patients allows clinicians to confirm that complete abortion has occurred without complications. In cases of uncertain outcome or suspected ectopic pregnancy, transvaginal ultrasonography and beta-human chorionic gonadotropin assays can assist in prompt diagnosis and management. As medical abortion with mifepristone and misoprostol becomes more prevalent in the United States, studies will be needed to further evaluate the effects of these modalities on medical abortion outcomes.
Asunto(s)
Abortivos/uso terapéutico , Aborto Inducido/métodos , Gonadotropina Coriónica/análisis , Pruebas de Embarazo , Ultrasonografía Prenatal , Femenino , Humanos , Mola Hidatiforme/terapia , Embarazo , Embarazo Ectópico/terapia , Neoplasias Uterinas/terapiaRESUMEN
We compared the published results of the 1994-1995 Population Council (PC) trial to those from the 1996-1997 Abortion Rights Mobilization (ARM) trial to determine whether 200 mg mifepristone with 800 micrograms vaginal misoprostol is more effective and has fewer side effects than 600 mg mifepristone with 400 micrograms oral misoprostol. The complete medical abortion rate was lower in the PC trial than the ARM trial: 92% compared with 97% up to 49 days LMP (p < 0.05) and 83% versus 96% from 50 to 56 days LMP (p < 0.05). Nausea and vomiting were reported more frequently in the PC trial. The overall acceptability of the procedure was lower in the PC trial (88%) than in the ARM trial (94%), (p < 0.05). Mifepristone can be reduced from 600 to 200 mg when followed by vaginal misoprostol without loss of efficacy. Vaginal misoprostol extends the efficacy to 56 days LMP and is associated with less nausea and vomiting. Home use of misoprostol is safe and acceptable to women and decreases the number of required visits from three to two in most cases.
Asunto(s)
Abortivos no Esteroideos/administración & dosificación , Abortivos Esteroideos/administración & dosificación , Aborto Inducido/métodos , Mifepristona/administración & dosificación , Misoprostol/administración & dosificación , Abortivos no Esteroideos/efectos adversos , Abortivos no Esteroideos/farmacología , Abortivos Esteroideos/efectos adversos , Abortivos Esteroideos/farmacología , Administración Intravaginal , Administración Oral , Adolescente , Adulto , Ensayos Clínicos como Asunto , Femenino , Humanos , Persona de Mediana Edad , Mifepristona/efectos adversos , Mifepristona/farmacología , Misoprostol/efectos adversos , Misoprostol/farmacología , Náusea/inducido químicamente , Visita a Consultorio Médico , Embarazo , Vómitos/inducido químicamenteRESUMEN
The aim of this study was to develop a profile of urban American women who chose Norplant(R), determine factors associated with retention and early termination of implants, and to determine reasons for early removal. A total of 197 adult black and Hispanic women who had Norplant inserted were followed prospectively for up to 5 years. Interval and cumulative termination rates were calculated. Data were stratified by race and analyzed to include lost-to-follow-up (LTFU) subjects. Multivariate survival analysis was used to determine variables independently associated with termination. Cumulative continuation rates were 68% after year 1 and 13% after year 4. Significant predictors of retention included black race and lower parity. Probability of early termination increased with higher parity and Hispanic race. For black subjects, recent use of hormonal contraception was a predictor of retention. Menstrual changes and weight concerns were common reasons for removal. The Norplant 1-year continuation rate is lower than previously reported, but is higher than reported for oral contraceptives and Depo-Provera(R). Future studies should stratify by age, race, and parity, and use standardized terminology to report intervals of use.
Asunto(s)
Anticoncepción/métodos , Anticonceptivos Femeninos/uso terapéutico , Levonorgestrel/uso terapéutico , Grupos Minoritarios , Congéneres de la Progesterona/uso terapéutico , Adulto , Negro o Afroamericano , Estudios de Cohortes , Anticonceptivos Femeninos/administración & dosificación , Anticonceptivos Femeninos/efectos adversos , Escolaridad , Femenino , Número de Embarazos , Hispánicos o Latinos , Humanos , Levonorgestrel/administración & dosificación , Levonorgestrel/efectos adversos , Trastornos de la Menstruación/inducido químicamente , Paridad , Congéneres de la Progesterona/administración & dosificación , Congéneres de la Progesterona/efectos adversos , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Análisis de Supervivencia , Estados Unidos , Población Urbana , Aumento de Peso , Población BlancaRESUMEN
The aim of this study was to compare the effectiveness, side effects, and acceptability of one-third the standard dose of mifepristone, i.e., 200 mg, and vaginal misoprostol 800 microg to induce abortion in subjects < or =56 days pregnant with subjects 57-63 days pregnant. A prospective multicenter trial enrolled healthy women > or =18 years, < or =63 days pregnant, and wanting an abortion. Women received mifepristone 200 mg orally, followed by misoprostol 800 microg vaginally, and returned 1-4 days later for ultrasound evaluation. A second dose of misoprostol was administered, if necessary. Surgical intervention was indicated for continuing pregnancy, excessive bleeding, or persistent products of conception 5 weeks later. Of 1137 subjects, 829 were in the < or =56 days pregnant group and 308 in the 57-63 days pregnant group. In all, 34 subjects had surgical intervention and 16 were lost to follow-up. Complete medical abortions occurred in 97% of subjects < or =56 days pregnant and 96% in the 57-63 days pregnant group. In all, 88% of subjects in the < or =56 days pregnant and 92% in the 57-63 days pregnant group bled within 4 h of using vaginal misoprostol. Comparing subjects < or =56 days pregnant with 57-63 days pregnant, there was less diarrhea (20% vs 29%, p = 0.002) and vomiting (33% vs 44%, p = 0.001), although side effects were acceptable to 82% of subjects in both groups. One subject in the < or =56 day group required a transfusion for delayed excessive bleeding. Although bleeding (p = 0.01) and pain (p = 0.02) were less acceptable in the 57-63 day group, 91% of subjects in both groups reported that the overall procedure was acceptable. In summary, low-dose mifepristone 200 mg and home administration of vaginal misoprostol 800 microg at 48 h were highly effective and acceptable to women < or =63 days pregnant, thereby expanding the number of women who can access a medical abortion.
PIP: The aim of this study was to compare the effectiveness, side effects, and acceptability of one-third the standard dose of mifepristone, i.e. 200 mg, and vaginal misoprostol 800 mcg to induce abortion in subjects 56 or fewer days pregnant with subjects 57-63 days pregnant. A prospective multicenter trial enrolled healthy women aged 18 years or older, 63 or fewer days pregnant, and wanting an abortion. Women received mifepristone 200 mg orally, followed by misoprostol 800 mcg vaginally, and returned 1-4 days later for ultrasound evaluation. A second dose of misoprostol was administered, if necessary. Surgical intervention was indicated for continuing pregnancy, excessive bleeding, or persistent products of conception 5 weeks later. Of 1137 subjects, 829 were in the 56 days or fewer pregnant group and 308 in the 57-63 days pregnant group. In all, 34 subjects had surgical intervention and 16 were lost to follow-up. Complete medical abortions occurred in 97% of subjects 56 or fewer days pregnant and 96% in the 57-63 days pregnant group. In all, 88% of subjects in the 56 days or fewer pregnant and 92% in the 57-63 days pregnant group bled within 4 hours of using vaginal misoprostol. Comparing subjects 56 or fewer days pregnant with 57-63 days pregnant, there was less diarrhea (20% vs. 29%, p = 0.0002) and vomiting (33% vs. 44%, p = 0.001), although side effects were acceptable to 82% of subjects in both groups. 1 subject in the 56 or fewer days group required a transfusion for delayed excessive bleeding. Although bleeding (p = 0.01) and pain (p = 0.02) were less acceptable in the 57-63 days group. 91% of subjects in both groups reported that the overall procedure was acceptable. In summary, low-dose mifepristone 200 mg and home administration of vaginal misoprostol 800 mcg at 48 hours were highly effective and acceptable to women 63 or fewer days pregnant, thereby expanding the number of women who can access a medical abortion.
Asunto(s)
Abortivos/administración & dosificación , Aborto Inducido/métodos , Mifepristona/administración & dosificación , Misoprostol/administración & dosificación , Administración Intravaginal , Adolescente , Adulto , Femenino , Edad Gestacional , Humanos , Persona de Mediana Edad , Mifepristona/efectos adversos , Misoprostol/efectos adversos , Satisfacción del Paciente , Embarazo , Primer Trimestre del Embarazo , Estudios Prospectivos , Encuestas y Cuestionarios , Resultado del TratamientoRESUMEN
Previous studies of medical abortion with mifepristone and a prostaglandin have reported percentages of subjects who experience cramping and/or bleeding relative to prostaglandin use. This is the first analysis of cramping and bleeding onset patterns in subjects treated with low-dose (200 mg) mifepristone and 800 microg vaginal misoprostol at 24, 48, or 72 h after mifepristone. We analyzed the cramping and bleeding onset patterns in subjects up to 8 weeks pregnant who used 800 microg vaginal misoprostol at 24, 48, or 72 h after 200 mg of oral mifepristone. We collected data from subjects' symptom diaries and divided symptom onset into 3 categories: before misoprostol use, 0--12 h following misoprostol, and more than 12 h after misoprostol. Of the 2,302 subjects, cramping and bleeding onset data were available for 2,030 (88%) and 2,123 (92%), respectively. Across all groups, 230 (11%) experienced cramping and 445 (21%) experienced bleeding before misoprostol use. There was a significantly higher percentage of subjects who experienced early cramping and/or early bleeding between the three treatment groups, and this was related to the interval between mifepristone and misoprostol. In the 12 h following misoprostol administration, cramping and bleeding patterns were similar in the three groups. The longer subjects waited to insert misoprostol, the more likely they were to experience early cramping and/or bleeding. After misoprostol insertion, cramping and bleeding patterns are similar regardless of treatment group. Patients and providers cannot rely on symptom onset to predict treatment success.
Asunto(s)
Abortivos Esteroideos/efectos adversos , Aborto Inducido/efectos adversos , Dismenorrea/inducido químicamente , Mifepristona/efectos adversos , Hemorragia Uterina/inducido químicamente , Abortivos no Esteroideos/administración & dosificación , Abortivos no Esteroideos/efectos adversos , Abortivos Esteroideos/administración & dosificación , Aborto Inducido/métodos , Adulto , Esquema de Medicación , Femenino , Humanos , Mifepristona/administración & dosificación , Misoprostol/administración & dosificación , Misoprostol/efectos adversos , Embarazo , Estadísticas no Paramétricas , Factores de TiempoRESUMEN
The objective of this study was to identify predictors of narcotic analgesic use during medical abortion. Two-thousand-seven-hundred-forty-seven women with pregnancies of 63 days gestational age or less received 200 mg mifepristone followed by at-home use of 800 microg vaginal misoprostol in two consecutive clinical trials in the United States, and also reported their use of analgesics. Overall, 79% of these subjects used narcotic analgesics. Women in the 2nd of the two studies were randomized to use misoprostol 24, 48, or 72 h after mifepristone. Those who were randomized to 24 h were more likely to use narcotic analgesics than those who were randomized to 48 or 72 h. In both studies, the use of narcotic analgesia during medical abortion was less prevalent among parous women and Asian women, and among those with a gestational age of 56 days or less. The clinic providing care for the patient was the most important determinant of narcotic analgesia use, even though the analgesia was used at home. Use of narcotic analgesics in these women undergoing medical abortion at home was more prevalent than use reported in previous studies where women underwent medical abortion in a clinical setting.
Asunto(s)
Abortivos no Esteroideos , Abortivos Esteroideos , Aborto Inducido/métodos , Analgésicos Opioides/administración & dosificación , Mifepristona , Misoprostol , Aborto Inducido/efectos adversos , Adolescente , Adulto , Femenino , Edad Gestacional , Número de Embarazos , Humanos , Paridad , Embarazo , Análisis de Regresión , Factores de TiempoRESUMEN
The objectives of this study were to determine the effectiveness, side effects, and acceptability of one-third the standard 600 mg dose of mifepristone (200 mg) to induce abortion. A prospective trial at seven sites enrolled women > or = 18 years, up to 8 weeks pregnant, and wanting an abortion. The women received 200 mg mifepristone orally, self-administered 800 micrograms misoprostol vaginally at home 48 h later, and returned 1-4 days later for ultrasound evaluation. Surgical intervention was indicated for continuing pregnancy, excessive bleeding, persistent products of conception 5 weeks later, or other serious medical conditions. Of the 933 subjects, 906 (97%) had complete medical abortions, 22 had surgical intervention, two were protocol failures, and three were lost to follow up. Of the 746 subjects who had no or minimal bleeding before misoprostol, 80% bled within 4 h and 98% within 24 h of using misoprostol. By day 7, 95% of women had a complete abortion. Side effects were aceptable in 85% of subjects, and 94% found the procedure acceptable. Low-dose mifepristone followed by vaginal misoprostol was highly effective as an abortifacient.
PIP: The effectiveness, side effects, and acceptability of 200 mg of mifepristone (one-third the standard dose) to induce medical abortion were investigated in a trial conducted at 7 centers in the US. 933 women with pregnancies up to 8 weeks' gestation were enrolled. They were given a 200-mg oral dose of mifepristone to be followed 48 hours later by home administration of 800 mcg of vaginal misoprostol and instructed to return 1-4 days later for ultrasound evaluation. 906 women (97%) experienced complete medical abortion, 22 required surgical abortion, 2 were protocol failures, and 3 were lost to follow-up. The most common indication for surgery was persistent or severe bleeding. Of the 746 women who had little or no bleeding before misoprostol administration, 593 (80%) bled within 4 hours and 731 (98%) within 24 hours of misoprostol. By day 7, 95% of women had experienced a complete abortion. The mean duration of bleeding was 17.4 days. 73% of subjects used an oral narcotic for pain. The most common mifepristone-related side effects were nausea and cramping; misoprostol-related side effects included cramping, fever, and chills. 74% found the pain related to the procedure acceptable and 85% rated its side effects as tolerable. Overall, 94% of subjects rated the medical abortion regimen as acceptable. These findings indicate that low-dose mifepristone is highly effective and acceptable as a self-administered abortifacient. The advantages of a lower dose of mifepristone include reduced manufacturing costs and less exposure to potential side effects.
Asunto(s)
Abortivos no Esteroideos/administración & dosificación , Abortivos Esteroideos/administración & dosificación , Aborto Inducido/métodos , Mifepristona/administración & dosificación , Misoprostol/administración & dosificación , Abortivos no Esteroideos/efectos adversos , Abortivos Esteroideos/efectos adversos , Aborto Inducido/efectos adversos , Administración Intravaginal , Administración Oral , Adolescente , Adulto , Quimioterapia Combinada , Femenino , Edad Gestacional , Humanos , Mifepristona/efectos adversos , Misoprostol/efectos adversos , Embarazo , Resultado del Embarazo , Estudios Prospectivos , Autoadministración , Ultrasonografía , Estados Unidos , United States Food and Drug Administration , Útero/diagnóstico por imagenRESUMEN
OBJECTIVE: To evaluate the safety and efficacy of oral methotrexate and vaginal misoprostol for medical abortion. METHODS: A prospective multicenter trial involved 300 women up to 49 days' gestation seeking elective abortion. Subjects received methotrexate 50 mg orally followed 5-6 days later by misoprostol 800 micrograms vaginally. The misoprostol dose was repeated if abortion did not occur. RESULTS: Complete abortion occurred in 273 of 299 women (91.3%; 95% confidence interval [CI] 87.5, 94.2%); one woman was lost to follow-up. Abortion occurred within 8 days of the methotrexate in 233 women (77.9%; 95% CI 72.8, 82.5%); the remaining 13.4% of women who aborted did so after a delay of 23.5 +/- 9.8 days (median 23 days, range 10-45). Vaginal bleeding lasted an average of 15 and 11 days in immediate and delayed-success abortions, respectively. Complete abortion rates decreased linearly with increasing body surface area. After methotrexate and misoprostol administration, nausea was reported in 37% and 33%, vomiting in 11% and 18%, diarrhea in 12% and 18%, and subjective fever or chills in 15% and 31% of subjects, respectively. CONCLUSION: Oral methotrexate followed by vaginal misoprostol is effective for abortion and represents an acceptable alternative to intramuscular methotrexate in regimens for medical abortion.
Asunto(s)
Abortivos no Esteroideos/administración & dosificación , Aborto Inducido , Metotrexato/administración & dosificación , Misoprostol/administración & dosificación , Abortivos no Esteroideos/efectos adversos , Administración Intravaginal , Administración Oral , Adulto , Intervalos de Confianza , Quimioterapia Combinada , Femenino , Estudios de Seguimiento , Humanos , Metotrexato/efectos adversos , Misoprostol/efectos adversos , Análisis Multivariante , Estudios Prospectivos , Análisis de RegresiónRESUMEN
BACKGROUND: There have been no US studies published on the effectiveness, safety, time to bleeding, and acceptability of misoprostol administered by vagina at home and repeated, if needed, after mifepristone was administered for abortion in women up to 8 weeks pregnant. METHODS: A prospective trial was conducted with women up to 8 weeks pregnant wanting an abortion. After receiving mifepristone 600 mg orally, subjects self-administered vaginal misoprostol 800 micrograms at home 2 days later. Subjects returned within 7 days, and if the gestational sac was still present on ultrasound, a repeat dose of misoprostol was administered in the office. Subjects completed a daily symptom log and a questionnaire on the acceptability of the procedures. RESULTS: Of the 166 subjects, 163 (98%) had a complete medical abortion. Three subjects presented with persistent bleeding and an incomplete abortion from 27 to 35 days after taking mifepristone and required surgical intervention. Vaginal spotting or bleeding occurred in 104 (62%) subjects before taking misoprostol, and 18 (11%) did not use misoprostol. Bleeding occurred on average 3.5 hours (SD, 3.2) after taking misoprostol. Six (4%) subjects required a second dose of misoprostol. Gastrointestinal side effects were common, mild, and brief. One hundred fifty-nine (96%) subjects agreed that the procedure went well, and 146 (90%) agreed that home administration of misoprostol was acceptable. CONCLUSIONS: Two days after taking mifepristone, misoprostol administered by vagina was found to be safe, highly effective, and acceptable to women. Since only 6 subjects needed a second dose of misoprostol, conclusions about repeat doses are not possible. This procedure is a promising alternative to surgical abortion.
Asunto(s)
Abortivos no Esteroideos , Abortivos Esteroideos , Aborto Inducido , Mifepristona , Misoprostol , Abortivos no Esteroideos/administración & dosificación , Abortivos no Esteroideos/efectos adversos , Abortivos Esteroideos/efectos adversos , Administración Intravaginal , Adolescente , Adulto , Femenino , Humanos , Mifepristona/efectos adversos , Misoprostol/administración & dosificación , Misoprostol/efectos adversos , Satisfacción del Paciente , Embarazo , Estudios Prospectivos , Autoadministración , Estados Unidos , Hemorragia Uterina/inducido químicamenteRESUMEN
OBJECTIVE: To determine whether methotrexate as a single agent for induced abortion in pregnancies up to 5 weeks is as effective, has fewer side effects and is as acceptable to subjects as the combination of methotrexate and misoprostol. STUDY DESIGN: Women with no greater than a 5-week gestation were compared with a historical control group of consecutive women presenting for a medical abortion matched for gestational age. Subjects received intramuscular methotrexate on day 1. The study group received no misoprostol until day 21, when it was offered if the abortion had not yet occurred. The control group self-administered one or more doses of misoprostol within the first week after methotrexate. A complete abortion was defined by either negative transvaginal ultrasound or negative urine pregnancy test. All subjects completed a daily symptom log and satisfaction questionnaire. The analysis consisted of a comparison of the study group and control group for completion and timing of the abortion, symptoms and subject satisfaction. RESULTS: There were 40 study subjects and 53 controls. All subjects had a medical abortion without surgery. Ten (25%) of the 40 study subjects reached study day 21 without bleeding: 4 used misoprostol and 6 chose to wait for the abortion to occur spontaneously. One of the 10 subjects had persistent embryonic cardiac activity at 21 days and aborted after misoprostol. The mean number of days to bleeding was 15.5 days (SD 7.8 days) for the study group as compared with 8.1 days (SD 11.3) (P = .0003) for the control group. There was no significant difference in the number of days of bleeding, gastrointestinal side effects or reported subject satisfaction. CONCLUSION: While methotrexate as a single agent was effective in inducing abortion in early pregnancy, 15% of the study subjects finally used misoprostol, the abortion took significantly longer, and side effects were not less common as compared with those in subjects who received the combination of methotrexate and misoprostol.
Asunto(s)
Abortivos no Esteroideos/farmacología , Aborto Inducido/métodos , Metotrexato/farmacología , Abortivos no Esteroideos/administración & dosificación , Abortivos no Esteroideos/efectos adversos , Adolescente , Adulto , Quimioterapia Combinada , Etnicidad , Femenino , Humanos , Metotrexato/administración & dosificación , Metotrexato/efectos adversos , Persona de Mediana Edad , Misoprostol/administración & dosificación , Selección de Paciente , Proyectos Piloto , Embarazo , Primer Trimestre del Embarazo , Estudios ProspectivosRESUMEN
OBJECTIVES: This study examined the effectiveness of an abortion by methotrexate and misoprostol, including side effects, subjects' satisfaction, and optimal treatment strategies. METHODS: The study evaluated a prospective ongoing trial of women with an 8-week gestation or less wanting an abortion. Subjects received intramuscular methotrexate (50 mg per m2 of body surface area) on day 1. Subjects self-administered misoprostol 800 micrograms orally or as a vaginal suppository or vaginal tablets either on day 3 to 4 or day 5 to 7. Repeat misoprostol 800 micrograms doses were used vaginally if there was no significant bleeding and the gestation was less than 12 weeks. Subjects with continuing pregnancies had a surgical abortion. Subjects completed a daily symptom log and a satisfaction questionnaire. A successful medical abortion was defined by vaginal bleeding without surgical intervention and either a negative urine pregnancy test or a negative transvaginal ultrasound. RESULTS: Of the 282 subjects, 274 (97%) had a medical abortion. Eight (3%) subjects required surgical intervention--four for continued pregnancies and four for excessive bleeding. One hundred and sixty-two (57%) subjects required only one dose of misoprostol and started bleeding, on average, 6.2 hours later. One hundred and twelve subjects (40%) required an average of 2.5 misoprostol doses and started bleeding, on average, 12.4 days after initial methotrexate injection. Misoprostol was more effective vaginally than orally. Gastrointestinal side effects were common, mild, and brief. Eighty-eight percent of the subjects agreed that the procedure went well. Subjects monitored with ultrasound completed the study sooner than those followed by beta-hCG levels. CONCLUSION: Methotrexate and misoprostol were effective in inducing an abortion up to 8 weeks' gestation. The procedure is a promising alternative to surgical abortion.
Asunto(s)
Abortivos no Esteroideos , Aborto Inducido/métodos , Inmunosupresores , Metotrexato , Misoprostol , Aborto Legal , Adolescente , Adulto , Esquema de Medicación , Quimioterapia Combinada , Femenino , Humanos , Satisfacción del Paciente , Embarazo , Primer Trimestre del Embarazo , Estudios Prospectivos , Resultado del TratamientoRESUMEN
OBJECTIVE: To describe the use of methotrexate and misoprostol to induce abortion in pregnancies up to 8 weeks when uterine or cervical anomalies make suction curettage difficult or impossible. METHODS: Four consecutive women, 8 weeks pregnant or less and with failed suction curettage, were given methotrexate 50 mg per square meter intramuscularly followed by a misoprostol 800-microgram suppository 72 hours later. A repeat dose of a misoprostol 800-microgram vaginal suppository was administered on day 4 if there was no bleeding, and an additional dose was given if the repeat beta-hCG titer had not decreased by at least 50%. Subjects were followed-up with serum or urine hCG assays. Complete abortion was defined by vaginal bleeding and a negative urine pregnancy test. Subjects completed a daily symptom log and a satisfaction questionnaire when the abortion was complete. RESULTS: The four women referred after failed suction curettage had the following anatomic problems: a uterus bicornis bicollis, a bicornuate uterus, uterine leiomyomas, and cervical stenosis resulting from previous laser surgery. All subjects had a complete abortion from methotrexate and misoprostol. Mild gastrointestinal side effects were reported by all four subjects: nausea (two subjects), vomiting (two), and diarrhea (two). The satisfaction questionnaire revealed that all subjects agreed with the statements that "Overall, the procedure went well" and "I would recommend this procedure over a surgical abortion." CONCLUSION: Methotrexate and misoprostol can induce an abortion when uterine or cervical anomalies make suction curettage difficult or impossible.