Is methotrexate better than placebo in the treatment of early ectopic pregnancies?

Phase 3

Recruiting

• Conditions: Ectopic pregnancy; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy

• Registration Number: ACTRN12618001128280
• Lead Sponsor: epean Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-10
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 76

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified