Comparison of success rates in the medical management of ectopic pregnancy with single-dose and multiple-dose administration of methotrexate: a prospective, randomized clinical trial
- PMID: 16650421
- DOI: 10.1016/j.fertnstert.2005.11.055
Comparison of success rates in the medical management of ectopic pregnancy with single-dose and multiple-dose administration of methotrexate: a prospective, randomized clinical trial
Abstract
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.
Comment in
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Statistical power to detect differences.Fertil Steril. 2007 Jun;87(6):1499; author reply 1499-500. doi: 10.1016/j.fertnstert.2007.01.141. Fertil Steril. 2007. PMID: 17544659 No abstract available.
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Designing bioequivalence studies--how much of a difference is acceptable?Fertil Steril. 2007 Sep;88(3):755; author reply 755-6. doi: 10.1016/j.fertnstert.2006.12.002. Epub 2007 Aug 6. Fertil Steril. 2007. PMID: 17678907 No abstract available.
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