Comparison of single and multiple dose methotrexate therapy for unruptured tubal ectopic pregnancy: a prospective randomized study.
OBJECTIVE
To compare the success rates of single and multiple dose methotrexate protocols for the treatment of unruptured tubal ectopic pregnancy.


METHODS
Prospective randomized controlled trial.


METHODS
Maternity and teaching hospital in Turkey.


METHODS
One hundred twenty women treated with methotrexate therapy for unruptured tubal ectopic pregnancy.


METHODS
Sixty-two women received a single dose and 58 received a multiple dose methotrexate regimen.


METHODS
Success rate of methotrexate therapy (women successfully treated with one injection and women who completed four doses).


RESULTS
In the single dose group, treatment was considered successful in 50 women (80.6%), whereas in the multiple dose group, 52 women (89.7%) responded to treatment (p = 0.21; OR 0.90, 95%CI 0.77-1.05). The average number of days required for human chorionic gonadotropin (hCG) levels to fall below 5 mU/mL was longer in the single dose (22.3 +/- 7.6) compared with the multiple dose group (18.3 +/- 10.7) (p = 0.03). In the single dose group fewer or 17 women (24.7%) experienced side-effects compared to 28 (48.3%) of those who had multiple doses (p = 0.02, OR 0.57, 95%CI 0.35-0.92).


CONCLUSIONS
A multiple dose methotrexate regimen for the treatment of unruptured tubal ectopic pregnancy is not more effective than a single dose one. In addition, multiple doses may cause more side-effects, but the time for hCG levels to fall below 5 mU/mL is shorter.
Guvendag Guven
Emine Seda
ES
Department of Obstetrics and Gynecology, Rize University, School of Medicine, Rize, Turkey. emineseda@yahoo.com
Dilbaz
Serdar
S
Dilbaz
Berna
B
Aykan Yildirim
Burcu
B
Akdag
Derya
D
Haberal
Ali
A
D000020:Abortifacient Agents, Nonsteroidal / Q000008:administration & dosage* / Q000009:adverse effects; D000293:Adolescent; D000328:Adult; D016009:Chi-Square Distribution; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005865:Gestational Age; D006801:Humans; D008727:Methotrexate / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D016017:Odds Ratio; D010298:Parity; D011247:Pregnancy; D011256:Pregnancy Outcome; D011274:Pregnancy, Tubal / Q000000981:diagnostic imaging / Q000188:drug therapy*; D011446:Prospective Studies; D018570:Risk Assessment; D018709:Statistics, Nonparametric; D016896:Treatment Outcome; D014463:Ultrasonography; D055815:Young Adult
D000020:Abortifacient Agents, Nonsteroidal; D008727:Methotrexate