I picked this article because it compares the traditional treatment of an ectopic pregnancy (methotrexate) to observational management, as long the Beta-HCG level is less than or equal to 1,500, which is right around what my patient had. This article stresses that methotrexate is not a benign drug, and too much money and time is spent on the work-up and treatment of an ectopic pregnancy, when that might not be necessary.
This study is also a multicenter placebo-controlled randomized control trial, where they were very clear with there inclusion criteria and randomization was computer generated, leaving little room for bias.
In order to be a part of the study, there needed to be an absence of both an embryonic heartbeat and hemoperitoneum on the US scan, as well as a B-HCG of less than 1500.
The study was done in the UK, published in 2016, had a total of 80 participants: 42 patients were prescribed 50 mg of methotrexate IM and 38 were prescribed Saline IM. Patients were assigned a pharmacy (computer generated), and were administered the medication / placebo by a medical professional (either doctor or nurse) that was independent from the study.
All women were given the medication within 24 hours of their initial visit (which was labeled as day 1) and then they had to follow up on days 4 and 7 for a repeat HCG test, as well as liver and renal function test.
The treatment was classified as unsuccessful if B-HCG levels had increased by more than 15% on two consecutive visits, thus they were offered surgical intervention. If women also started to experience abdominal pain with evidence of hemoperitoneum on US, surgery was also offered.
Once the B-HCG level started to drop greater than 15%, weekly blood draws were arranged every week until HCG level were less than 20. If patients did not reach this 15% goal, blood test were arranged every 2 days to make sure the HCG level was not rising.
Primary outcome was measured as a B-HCG level of less than 20 and resolution of clinical symptoms.
The success rate for women on methotrexate was 83% versus the placebo which was 76%, and this difference was not statistically significant. The failure rate was significantly higher for those women that presented with a baseline HCG level of 1000-1500, with a success rate of 66% with methotrexate and 33% with observational. The higher the level of HCG, the greater risk of failure of both the medication and the observation study.
The final conclusion was made to be that methotrexate was not a superior method of treatment in women with ectopic pregnant with an HCG level of 1500 or less.
Jurkovic_et_al-2017-Ultrasound_in_Obstetrics_&_Gynecology
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