Randomised double blind control trial of single dose methotrexate versus expectant management in women with tubal ectopic pregnancy - N/A
Phase 1
- Conditions
- Tubal ectopic pregnancy
- Registration Number
- EUCTR2004-003753-56-GB
- Lead Sponsor
- King's College Hospital NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 70
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
Haemodynamically unstable, viable fetus, abnormal blood tests, beta-hCG more than 1500, informed consent declined.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method