OBJECTIVE: To assess whether success rate differs in single-dose versus multiple-dose administration of methotrexate (MTX) in medical management of unruptured ectopic pregnancies. DESIGN: Prospective randomized clinical trial. SETTING:Tertiary university hospital. PATIENT(S): The study population included 108 patients presenting with unruptured ectopic pregnancies who fulfilled the criteria for medical management. INTERVENTION(S): A single dose (study group) or multiple doses (control group) of MTX were administered IM. MAIN OUTCOME MEASURE(S): Success rate of medical management in each group. RESULT(S): Of the 54 patients on the single-dose protocol, treatment was considered successful in 48 patients (88.9%). Of the 54 patients on the multiple-dose protocol, 50 participants responded to the treatment (92.6%). The difference between success rates in the two groups was not statistically significant (P=.7; odds ratio 0.64; 95% confidence interval 0.17-2.4). In the single-dose and multiple-dose groups, 15 (27.8%) and 20 (37%) patients, respectively, had complications (P=.3). CONCLUSION(S): The results of our study showed that single-dose treatment with MTX could be as successful as multiple doses. The incidence of complications did not differ between the two groups. It appears that single-dose treatment could be the first line of treatment in selected patients.
RCT Entities:
OBJECTIVE: To assess whether success rate differs in single-dose versus multiple-dose administration of methotrexate (MTX) in medical management of unruptured ectopic pregnancies. DESIGN: Prospective randomized clinical trial. SETTING: Tertiary university hospital. PATIENT(S): The study population included 108 patients presenting with unruptured ectopic pregnancies who fulfilled the criteria for medical management. INTERVENTION(S): A single dose (study group) or multiple doses (control group) of MTX were administered IM. MAIN OUTCOME MEASURE(S): Success rate of medical management in each group. RESULT(S): Of the 54 patients on the single-dose protocol, treatment was considered successful in 48 patients (88.9%). Of the 54 patients on the multiple-dose protocol, 50 participants responded to the treatment (92.6%). The difference between success rates in the two groups was not statistically significant (P=.7; odds ratio 0.64; 95% confidence interval 0.17-2.4). In the single-dose and multiple-dose groups, 15 (27.8%) and 20 (37%) patients, respectively, had complications (P=.3). CONCLUSION(S): The results of our study showed that single-dose treatment with MTX could be as successful as multiple doses. The incidence of complications did not differ between the two groups. It appears that single-dose treatment could be the first line of treatment in selected patients.
Authors: Jennifer Y Hsu; Ling Chen; Arielle R Gumer; Ana I Tergas; June Y Hou; William M Burke; Cande V Ananth; Dawn L Hershman; Jason D Wright Journal: Am J Obstet Gynecol Date: 2017-03-10 Impact factor: 8.661