Methotrexate versus expectant management in women with ectopic pregnancy
| ISRCTN | ISRCTN48210491 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48210491 |
| EudraCT/CTIS number | 2006-003003-39 |
| Secondary identifying numbers | N/A |
- Submission date
- 28/04/2006
- Registration date
- 28/04/2006
- Last edited
- 23/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr P.J. Hajenius
Scientific
Scientific
Academic Medical Center, (AMC)
Department of Obstetrics and Gynaecology, H4-205
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 5663693 |
|---|---|
| metex@amc.uva.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information can be found on the trial website at http://www.metexstudy.nl/ (Dutch only) |
| Scientific title | Methotrexate versus expectant management in women with ectopic pregnancy |
| Study acronym | METEX |
| Study objectives | To study whether in women with suspected ectopic pregnancy with low but plateauing serum human Chorionic Gonadotropin (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. |
| Ethics approval(s) | 1. Medical ethical committee (METC) of the Academic Medical Centre, Amsterdam, ref: 06/075 2. Central Committee on Research involving Human Subjects (CCMO), ref: NL11168.018.06, EudraCT number: 2006-003003-39 |
| Health condition(s) or problem(s) studied | Ectopic pregnancy |
| Intervention | Systemic methotrexate in a single dose intramuscular regimen (1 mg/kg body weight) versus expectant management. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Methotrexate |
| Primary outcome measure | An uneventful decline of serum hCG to an undetectable level by primary treatment, i.e., single dose systemic methotrexate or expectant management. |
| Secondary outcome measures | 1. Number of (re)interventions (additional methotrexate injections or surgical procedures for persistent trophoblast and/or clinical signs) 2. Treatment complications 3. Future fertility 4. Health related quality of life 5. Financial costs 6. Patients preferences |
| Overall study start date | 01/06/2006 |
| Completion date | 01/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 72 |
| Key inclusion criteria | 1. All haemodynamically stable patients 2. greater than 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 less than 1500 IU/l or with a Pregnancy of Unknown Location (PUL) and a plateauing serum hCG concentration less than 2000 IU/l (persisting PUL) |
| Key exclusion criteria | 1. Patients with a viable ectopic pregnancy 2. Signs of tubal rupture or active intra-abdominal bleeding 3. Abnormalities in liver or renal function or in full blood count |
| Date of first enrolment | 01/06/2006 |
| Date of final enrolment | 01/06/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Center (AMC) (The Netherlands)
University/education
University/education
Department of Obstetrics and Gynaecology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Website | http://www.amc.uva.nl/index.cfm?sid=1 |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Research organisation
ZonMw
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 19/06/2008 | Yes | No | |
| Results article | results | 01/01/2013 | Yes | No | |
| Abstract results | results (abstract) | 01/06/2013 | No | No | |
| Results article | health-related quality of life results | 01/09/2015 | Yes | No |
Editorial Notes
23/05/2016: Publication reference added.
