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Methotrexate versus Expectant management in women with ectopic pregnancy.


- candidate number1983
- NTR NumberNTR611
- ISRCTNISRCTN48210491
- Date ISRCTN created28-apr-2006
- date ISRCTN requested25-apr-2006
- Date Registered NTR19-feb-2006
- Secondary IDsN/A 
- Public TitleMethotrexate versus Expectant management in women with ectopic pregnancy.
- Scientific TitleMethotrexate versus Expectant management in women with ectopic pregnancy.
- ACRONYMMETEX study
- hypothesisTo 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.
- Healt Condition(s) or Problem(s) studiedEctopic pregnancy, Pregnancy of unknown location (PUL), Low serum Humane Chorion Gonadotropine (HCG)
- Inclusion criteriaAll 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 criteriaPatients 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jun-2006
- planned closingdate1-jun-2009
- Target number of participants72
- InterventionsSystemic methotrexate in a single dose intramuscular regimen (1 mg/kg body weight) versus expectant management.
- Primary outcomeThe 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 outcomeSecondary 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.
- Timepoints
- Trial web sitehttp://www.studies-obsgyn.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. PhD. P.J. Hajenius
- CONTACT for SCIENTIFIC QUERIESMD. PhD. P.J. Hajenius
- Sponsor/Initiator Academic Medical Center (AMC), Department of Obstetrics and Gynaecology
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD19-feb-2006 - 6-sep-2006


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