Methotrexate versus expectant management in women with ectopic pregnancy (METEX study) - METEX study
- Conditions
- Women with an ectopic pregnancy with low but plateauing serum hCG concentrations.
- Registration Number
- EUCTR2006-003003-39-NL
- Lead Sponsor
- Academic Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 72
All hemodynamically stable patients = 18 years with either an ectopic pregnancy (a visible ectopic pregnancy or an ectopic mass on TVS) and a plateauing serum hCG concentration < 1,500 IU/L or with a PUL and a plateauing serum hCG concentration < 2,000 IU/L (persisting PUL) will be eligible for the trial. The difference in serum hCG cut-off levels for these two entities is based on our earlier work.
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
Patients with a viable ectopic pregnancy, signs of tubal rupture or active intra abdominal bleeding, and/or abnormalities in liver or renal function or in full blood count will not be included.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method