Randomised double blind control trial of single dose methotrexate versus expectant management in women with tubal ectopic pregnancy - N/A

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-003753-56-GB

Enrollment

Registered

2009-04-07

Start date

2005-05-31

Completion date

Unknown

Last updated

2018-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tubal ectopic pregnancy

Interventions

Trade Name: Methotrexate Product Name: Methotrexate Product Code: N/A Pharmaceutical Form: Injection* INN or Proposed INN: METHOTREXATE CAS Number: 59052 Concentration unit: mg/l milligram(s)/litre Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Haemodynamic stability, non-viable fetus, normal renal and liver function and a normal full blood count, beta-hCG less than 1500, written informed consent obtained. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Haemodynamically unstable, viable fetus, abnormal blood tests, beta-hCG more than 1500, informed consent declined.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of methotrexate as compared to placebo in the non-surgical management of tubal ectopic pregnancies;Secondary Objective: There will be no secondary efficacy parameters to be assessed in this study.;Primary end point(s): Beta-hCG of less than 20iu/L without the need for additional intervention	—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026