None listed
Conditions
Brief summary
Tubal ectopic pregnancies (EPs) are diagnosed earlier in their natural history due to transvaginal ultrasound (TVS) technology. There is no evidence that methotrexate (MTX) is necessary for all these early EPs, as many may resolve spontaneously in the absence of any treatment. Two recent randomised controlled trials demonstrate the safety of expectant management for patients with early EPs. In these studies, patients were randomised and treated with MTX or placebo on the day of diagnosis. By monitoring them expectantly without therapy for 48 hours following diagnosis, it is possible to identify patients with declining hCG levels, representing a subset of patients with spontaneous resolution of the EP. As such, the aim of this study is to verify if MTX is more effective than the placebo in patients with tubal EP and rising/plateauing serum hCG (< 1500 IU/L) levels at a 48-hour mark following definitive diagnosis. Our goal is to study treatment with systemic MTX in a single dose intramuscular regimen in patients with EP and increasing/plateauing serum hCG concentrations, with regards to treatment success, complications and length of follow-up. The primary hypothesis is that single-dose MTX is more effective than a placebo in patients with an early tubal EPs and rising or plateauing hCG.
Interventions
To study treatment with systemic methotrexate (MTX) in a single dose intramuscular regimen (50mg/m^2 based on patient body surface area) in patients with ectopic pregnancy (EP) and increasing/plateauing serum hCG concentrations, with regards to treatment success, complications and length of follow-up. The primary hypothesis is that single-dose MTX is more effective than a placebo in patients with an early tubal EPs and rising or plateauing hCG. Since the intervention is administered by a clinica
To study treatment with systemic methotrexate (MTX) in a single dose intramuscular regimen (50mg/m^2 based on patient body surface area) in patients with ectopic pregnancy (EP) and increasing/plateauing serum hCG concentrations, with regards to treatment success, complications and length of follow-up. The primary hypothesis is that single-dose MTX is more effective than a placebo in patients with an early tubal EPs and rising or plateauing hCG. Since the intervention is administered by a clinically-trained nurse, there are no concerns with intervention adherence. In the traditional single dose MTX protocols, additional doses may be required if the EP is not resolving. In this study, multiple doses of MTX or placebo may be administered, which is one of the secondary outcomes.
Sponsors
Nepean Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
13 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Haemodynamically stable patients, with a visible tubal EP on transvaginal ultrasound (an ectopic gestational sac with or without the embryo, or an ectopic mass) and serum hCG concentrations rising after 48 hours observation and below 1500 IU/L are eligible for the trial. This hCG cut-off level is based on previous uncontrolled and controlled studies on single dose MTX. We have adopted inclusion criteria widely used in studies on MTX17. Using these criteria, we estimate approximately 24% of all EPs will be eligible for entry in the trial. Patients of all ages will be considered eligible.
Exclusion criteria
Patients with declining hCG, a viable EP (embryonic cardiac activity on ultrasound), severe abdominal pain and/or peritonism, haemodynamic instability, evidence of significant haemoperitoneum on scan (> 300ml, blood above the uterine fundus and/or in the Morison's pouch) or contraindications to MTX (leukopaenia, thrombocytopaenia, or elevated serum liver enzymes or creatinine) are not included.
Outcome results
None listed