The METEX Study: methotrexate versus expectant management in women with ectopic pregnancy
Phase 4
- Conditions
- Ectopic PregnancyTubal Pregnancy10010273
- Registration Number
- NL-OMON30421
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 72
Inclusion Criteria
All hemodynamically stable patients >= 18 years with either an ectopic pregnancy (a visible ectopic pregnancy or an ectopic mass on transvaginal sonography) and a plateauing serum hCG concentration < 1,500 IU/L or with a Pregnancy of Unknown Location (PUL) and a plateauing serum hCG concentration < 2,000 IU/L (persisting PUL).
Exclusion Criteria
Patients with a viable ectopic pregnancy, signs of tubal rupture and/or active intra abdominal bleeding or abnormalities in liver or renal function or in full blood count.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measure is an uneventful decline of serum hCG to an<br /><br>undetectable level. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes are number of (re)interventions (additional methotrexate<br /><br>and/or surgery), treatment complications, health related quality of life,<br /><br>future fertility, and financial costs. The analysis will be performed according<br /><br>to the intention to treat principle. Moreover, patients* preferences will be<br /><br>assessed.</p><br>