ectopic pregnancy Pregnancy of unknown location (PUL) low and plateauing serum hCG methotrexate expectant management
Conditions
Interventions
Systemic methotrexate in a single dose intramuscular regimen (1 mg/kg body weight) versus expectant management.
Sponsors
Academic Medical Center, University of Amsterdam
Obstetrics and Gynaecology (H4-205)
Meibergdreef 9
1105 AZ AMSTERDAM
THE NETHERLANDS
tel: +31 20 5663693
fax: +31 20 6963489
Eligibility
Inclusion criteria
Inclusion criteria: All hemodynamically stable patients > 18 years with either a suspected ectopic pregnancy (a visible ectopic pregnancy or an ectopic mass on Trans Vaginal 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
Exclusion criteria: Patients with a viable ectopic pregnancy, signs of tubal rupture or active intra abdominal bleeding, abnormalities in liver or renal function or in full blood count.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is an uneventful decline of serum hCG to an undetectable level by primary treatment, i.e. single dose systemic methotrexate or expectant management. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are number of (re)interventions (additional methotrexate injections or surgical procedures for persistent trophoblast and/or clinical signs), treatment complications, future fertility, health related quality of life, financial costs, and patients preferences. | — |
Contacts
Public ContactP.J. Hajenius
Academic Medical Center, (AMC), Department of Obstetrics and Gynaecology, H4-205, P.O. Box 22660
Outcome results
None listed