Methotrexate Treatment for Ectopic Pregnancy
Ectopic Pregnancy
About this trial
This is an interventional treatment trial for Ectopic Pregnancy
Eligibility Criteria
Inclusion Criteria:
- tubal pregnancy
- tubal pregnancy except interstitial pregnancy
- a pretreatment β-hCG level <15000 mIU/mL
- a gestational sac with a largest diameter <4 cm
- hemodynamically stable status
- agreement to methotrexate treatment and follow up
Exclusion Criteria:
- heterotrophic pregnancy
- a presence of embryonic cardiac motion
- clinically or sonographically suspected tubal rupture
- laboratory tests showing possible deleterious effects of methotrexate treatment on organ functions
Sites / Locations
- CHA Gangnam Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Single-dose methotrexate protocol
Two-dose methotrexate protocol
Participants in the "single-dose protocol" group received intramuscular methotrexate at single dose of 50 mg/m2 on day 0 (the initial day of treatment). The β-hCG levels were then measured on day 4 and 7. If there was at least 15% β-hCG drop between day 4 and 7, the treatment was deemed successful and the participants were then followed with weekly β-hCG measurements until the results was negative. If a 15% drop on day 4 and 7 did not occur, a second dose was administrated on day 7 and β-hCG levels were then measured on day 11 and 14. Participants were referred for surgical treatment if β-hCG levels fell <15% between day 11 and 14.
Participants in the "two-dose protocol" group received intramuscular methotrexate twice at dose of 50 mg/m2 on day 0 and 4. A third dose of methotrexate was given on day 7 if β-hCG levels did not fall 15% between day 4 and 7 after two-dosing. A fourth dose was administered on day 11 if β-hCG levels fell <15% between day 7 and 11. Then, a final β-hCG level was checked on day 14. If a 15% drop was not seen, the medical treatment was deemed refractory and the patients were referred for surgical treatment.