Methotrexate Treatment for Ectopic Pregnancy
Condition: Ectopic Pregnancy
MeSH terms: Pregnancy, Ectopic; Cardiac Complexes, Premature
Study type: Interventional
Phase: Phase 3

Summary: 
      Ectopic pregnancy is an important cause of maternal morbidity and occasionally mortality.
      Deaths associated with ectopic pregnancy have declined, though approximately 75% of deaths in
      the first trimester and 9-13% of all pregnancy-related deaths are associated ectopic
      pregnancy. The main stays of management for ectopic pregnancy were surgery and medical
      treatment. Medical management with systemic methotrexate administration avoids the inherent
      morbidity of anesthesia and surgery is cost-effective, and also offers success rates
      comparable to surgical management, with no loss in future potential fertility.

      However, although medical management using methotrexate is used commonly, there is no solid
      consensus regarding dose protocol. Currently, there are three methotrexate protocols for the
      treatment of an ectopic pregnancy, "multi-dose", "single-dose", or "two-dose". Among them,
      the multi-dose protocol includes the administration of 4 methotrexate doses alternating with
      leucovorin (rescue regimen). As a result of the multiple dosing of methotrexate, side effects
      are more common. In contrast, the advantages of the single-dose protocol include elimination
      of a rescue regimen, lower incidence of adverse effects, and better compliance. However, the
      single-dose protocol was found to be associated with a considerably lower success rate as
      compared with the multi-dose protocol (88% versus 93%) in a recent meta-analysis. The
      two-dose protocol, which it balances efficacy and safety/convenience, was described as a
      cross between the multi-dose and single-dose protocols.

      However, there were a few studies comparing between single-dose and two-dose protocol. The
      purpose of this prospective randomized trial was to compared the success rates of single-dose
      and two-dose methotrexate protocol for the treatment of tubal ectopic pregnancy.
    


Intervention name(s): Single-dose Methotrexate; Two-dose methotrexate protocol
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment