No registrations found.
ID
Source
Brief title
Health condition
ectopic pregnancy
Pregnancy of unknown location (PUL)
low and plateauing serum hCG
methotrexate
expectant management
Sponsors and support
Obstetrics and Gynaecology (H4-205)
Meibergdreef 9
1105 AZ AMSTERDAM
THE NETHERLANDS
tel: +31 20 5663693
fax: +31 20 6963489
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
The incidence of ectopic pregnancy is approximately 1-2 % of all pregnancies. An early diagnosis is possible by transvaginal sonography in combination with serum human chorionic gonadotrophin (hCG) measurements. Women with low but plateauing serum hCG concentrations have thus far been offered medical treatment with methotrexate. Systemtic methotrexate has been shown to be effective treatment for tubal pregnancy compared with surgery in several randomised trials. Methotrexate was cost effective in women with serum hCG < 2.000 IU/L but had a more negative impact on patients health related quality of life. Side effects include stomatitis, conjunctivitis, gastritis-enteritis, impaired liver function, bone marrow depression, and photosensitivity. Methotrexate has been shown to be safe with virtually no adverse effects reported on reproductive outcome. However, there is no evidence on the effects of treatment in this particular subgroup of women with low but plateauing serum hCG concentrations, which represents about 10% of women presenting with suspected ectopic pregnancy. Expectant management has been practiced based on the acknowledgement that the natural course of many early ectopic pregnancies is a self limiting process, ultimately resulting in tubal abortion or reabsorption. The objective is whether in women with suspected ectopic pregnancy with low but plateauing serum hCG concentrations additional treatment with systemic methotrexate in a single dose intramuscular regimen is superior over expectant management in terms of tubal rupture, future pregnancy, health related quality of life and costs.
Study objective
To study whether in women with suspected ectopic pregnancy with low but plateauing serum hCG concentrations additional treatment with systemic methotrexate in a single dose intramuscular regimen is superior over expectant management in terms of tubal rupture, future pregnancy, health related quality of life and costs.
Intervention
Systemic methotrexate in a single dose intramuscular regimen (1 mg/kg body weight) versus expectant management.
P.O. Box 22660
P.J. Hajenius
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5663693 or +31 (0)20 5663654
p.hajenius@amc.uva.nl or metex@amc.uva.nl
P.O. Box 22660
P.J. Hajenius
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5663693 or +31 (0)20 5663654
p.hajenius@amc.uva.nl or metex@amc.uva.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL555 |
| NTR-old | NTR611 |
| Other | : N/A |
| ISRCTN | ISRCTN48210491 |