Effectiveness of expectant management versus methotrexate in tubal ectopic pregnancy: a double-blind randomized trial

Silva, Priscila Matthiesen; Júnior, Edward Araujo; Cecchino, Gustavo Nardini; Elito, Júlio; Camano, Luiz

doi:10.1007/s00404-014-3513-0

Cited by 27 publications

(35 citation statements)

References 15 publications

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“…However, all women had plateauing serum β‐hCG levels, which many clinicians feel compelled to treat. The study by Silva et al . differs from the other studies as they included only women with ectopic pregnancy and falling serum β‐hCG levels.…”

Section: Discussionmentioning

confidence: 96%

“…In the study by Korhonen et al ,. women in the treatment arm were prescribed a very low dose of oral methotrexate while the systemic parenteral route was used in the other two trials. In two out of these three trials, the researchers included only ectopic pregnancies presenting with serum β‐hCG levels of < 2000 IU/L.…”

Section: Discussionmentioning

confidence: 99%

“…Two studies included only women with a tubal ectopic pregnancy that was positively identified on ultrasound. In the study by Van Mello et al ,.…”

Section: Discussionmentioning

confidence: 99%

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Single-dose systemic methotrexatevsexpectant management for treatment of tubal ectopic pregnancy: a placebo-controlled randomized trial

Memtsa

Sawyer

Donaldson

et al. 2017

Ultrasound Obstet Gynecol

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Section: Discussionmentioning

confidence: 96%

Section: Discussionmentioning

confidence: 99%

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Single-dose systemic methotrexatevsexpectant management for treatment of tubal ectopic pregnancy: a placebo-controlled randomized trial

Memtsa

Sawyer

Donaldson

et al. 2017

Ultrasound Obstet Gynecol

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“…Mientras menor valor de β-hCG de las pacientes seleccionadas para tratamiento médico, mejor será el porcentaje de éxito (93.75% en nuestro estudio con β-hCG < 1500). Se debe tener en consideración que estudios recientes muestran que con valores de β-hCG menor a 2000 mUI/ml no habría diferencia significativa entre terapia médica y manejo expectante (16,18).…”

Section: Discussionunclassified

“…La dosis única de metotrexato no ha mostrado diferencias en tasas de éxito respecto a la dosis múltiple, pero sí se asocia a menor frecuencia de efectos adversos y una menor necesidad de controles (13)(14)(15)(16)(17).…”

Section: Introductionunclassified

Tratamiento médico del embarazo ectópico no complicado; experiencia del hospital regional de talca

Q²,

et al. 2017

Rev. chil. obstet. ginecol.

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Tratamiento médico del embarazo ectópico no complicado; experiencia del hospital regional de talca 46 RESUMENEl tratamiento médico del embarazo ectópico (EE) no complicado es una alternativa para el manejo de esta patología. Existen distintos criterios para su uso y las tasas de éxito publicadas son variadas.Realizamos una revisión de 34 casos de pacientes con diagnóstico de EE no complicado en el Hospital Regional de Talca, reportándose una tasa de éxito con dosis única de metotrexato de 65%. Un 20,5% de las pacientes requirieron una dosis adicional de metotrexato. La tasa total de éxito con tratamiento médico alcanzó un 73.5%.El manejo médico es una alternativa efectiva a la cirugía en pacientes bien seleccionadas. Se debe evaluar de manera local los criterios de inclusión para el tratamiento médico del EE no complicado.PALABRAS CLAVES: Embarazo ectópico, tratamiento médico, metotrexato. ABSTRACTMedical treatment of non complicated ectopic pregnancy is an alternative for the management of this pathology. There are different criteria for it's use, and published success rates are heterogeneous.We reviewed 34 cases of patients with diagnosis of no complicated ectopic pregnancy in Hospital Regional de Talca, and we reported a success rate of 65% with a single dose of methotrexate. 20,5% of patients needed an additional dose of medication. The global success rate of medical treatment was 73,5%.No surgical management is an effective alternative for well-selected patients. The criteria for medical treatment of no complicated EE must be evaluated locally.

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Effect of an Active vs Expectant Management Strategy on Successful Resolution of Pregnancy Among Patients With a Persisting Pregnancy of Unknown Location

Barnhart

Hansen

Stephenson

et al. 2021

JAMA

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IMPORTANCEWomen with an early nonviable pregnancy of unknown location are at high risk of ectopic pregnancy and its inherent morbidity and mortality. Successful and timely resolution of the gestation, while minimizing unscheduled interventions, are important priorities.OBJECTIVE To determine if active management is more effective in achieving pregnancy resolution than expectant management and whether the use of empirical methotrexate is noninferior to uterine evacuation followed by methotrexate if needed. DESIGN, SETTING, AND PARTICIPANTS This multicenter randomized clinical trial recruited 255 hemodynamically stable women with a diagnosed persisting pregnancy of unknown location between July 25, 2014, and June 4, 2019, in 12 medical centers in the United States (final follow up, August 19, 2019).INTERVENTIONS Eligible patients were randomized in a 1:1:1 ratio to expectant management (n = 86), active management with uterine evacuation followed by methotrexate if needed (n = 87), or active management with empirical methotrexate using a 2-dose protocol (n = 82). MAIN OUTCOMES AND MEASURESThe primary outcome was successful resolution of the pregnancy without change from initial strategy. The primary hypothesis tested for superiority of the active groups combined vs expectant management, and a secondary hypothesis tested for noninferiority of empirical methotrexate compared with uterine evacuation with methotrexate as needed using a noninferiority margin of −12%. RESULTS Among 255 patients who were randomized (median age, 31 years; interquartile range, 27-36 years), 253 (99.2%) completed the trial. Ninety-nine patients (39%) declined their randomized allocation (26.7% declined expectant management, 48.3% declined uterine evacuation, and 41.5% declined empirical methotrexate) and crossed over to a different group. Compared with patients randomized to receive expectant management (n = 86), women randomized to receive active management (n = 169) were significantly more likely to experience successful pregnancy resolution without change in their initial management strategy (51.5% vs 36.0%; difference, 15.4% [95% CI, 2.8% to 28.1%]; rate ratio, 1.43 [95% CI, 1.04 to 1.96]). Among active management strategies, empirical methotrexate was noninferior to uterine evacuation followed by methotrexate if needed with regard to successful pregnancy resolution without change in management strategy (54.9% vs 48.3%; difference, 6.6% [1-sided 97.5% CI, −8.4% to ϱ]). The most common adverse event was vaginal bleeding for all of the 3 management groups (44.2%-52.9%).CONCLUSIONS AND RELEVANCE Among patients with a persisting pregnancy of unknown location, patients randomized to receive active management, compared with those randomized to receive expectant management, more frequently achieved successful pregnancy resolution without change from the initial management strategy. The substantial crossover between groups should be considered when interpreting the results.

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Effectiveness of expectant management versus methotrexate in tubal ectopic pregnancy: a double-blind randomized trial

Abstract: This study showed no statistically significant difference between the treatment with methotrexate and placebo, with similar success rates and similar time interval for β-hCG to become undetectable.

Cited by 27 publications

References 15 publications

Single-dose systemic methotrexatevsexpectant management for treatment of tubal ectopic pregnancy: a placebo-controlled randomized trial

Single-dose systemic methotrexatevsexpectant management for treatment of tubal ectopic pregnancy: a placebo-controlled randomized trial

Tratamiento médico del embarazo ectópico no complicado; experiencia del hospital regional de talca

Effect of an Active vs Expectant Management Strategy on Successful Resolution of Pregnancy Among Patients With a Persisting Pregnancy of Unknown Location

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