Condition category
Pregnancy and Childbirth
Date applied
28/04/2006
Date assigned
28/04/2006
Last edited
23/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.metexstudy.nl/

Contact information

Type

Scientific

Primary contact

Dr P.J. Hajenius

ORCID ID

Contact details

Academic Medical Center
(AMC)
Department of Obstetrics and Gynaecology
H4-205
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5663693
metex@amc.uva.nl

Additional identifiers

EudraCT number

2006-003003-39

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Methotrexate versus expectant management in women with ectopic pregnancy

Acronym

METEX

Study hypothesis

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

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

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information can be found on the trial website at http://www.metexstudy.nl/ (Dutch only)

Condition

Ectopic pregnancy

Intervention

Systemic methotrexate in a single dose intramuscular regimen (1 mg/kg body weight) versus expectant management.

Intervention type

Drug

Phase

Not Applicable

Drug names

Methotrexate

Primary outcome measures

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 trial start date

01/06/2006

Overall trial end date

01/06/2009

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

72

Participant 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

Recruitment start date

01/06/2006

Recruitment end date

01/06/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Center (AMC) (The Netherlands)

Sponsor details

Department of Obstetrics and Gynaecology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

University/education

Website

http://www.amc.uva.nl/index.cfm?sid=1

Funders

Funder type

Research organisation

Funder name

ZonMw

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2008 protocol in http://www.ncbi.nlm.nih.gov/pubmed/18565217
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23081873
3. 2013 results (abstract) in http://humrep.oxfordjournals.org/content/28/suppl_1/i139.full
4. 2015 health-related quality of life results in: http://www.ncbi.nlm.nih.gov/pubmed/26125101

Publication citations

  1. Results

    van Mello NM, Mol F, Verhoeve HR, van Wely M, Adriaanse AH, Boss EA, Dijkman AB, Bayram N, Emanuel MH, Friederich J, van der Leeuw-Harmsen L, Lips JP, Van Kessel MA, Ankum WM, van der Veen F, Mol BW, Hajenius PJ, Methotrexate or expectant management in women with an ectopic pregnancy or pregnancy of unknown location and low serum hCG concentrations? A randomized comparison., Hum. Reprod., 2013, 28, 1, 60-67, doi: 10.1093/humrep/des373.

  2. van Mello NM, Mol F, Adriaanse AH, Boss EA, Dijkman AB, Doornbos JP, Emanuel MH, Friederich J, Leeuw-Harmsen Lv, Lips JP, van Santbrink EJ, Verhoeve HR, Visser H, Ankum WM, Veen Fv, Mol BW, Hajenius PJ, The METEX study: methotrexate versus expectant management in women with ectopic pregnancy: a randomised controlled trial., BMC Womens Health, 2008, 8, 10, doi: 10.1186/1472-6874-8-10.

  3. Results

    van Mello NM, Mol F, Hajenius PJ, Ankum WM, Mol BW, van der Veen F, van Wely M, Randomized comparison of health-related quality of life in women with ectopic pregnancy or pregnancy of unknown location treated with systemic methotrexate or expectant management, Eur J Obstet Gynecol Reprod Biol, 2015 , 192, 1-5, doi: 10.1016/j.ejogrb.2015.06.007.

Additional files

Editorial Notes

23/05/2016: Publication reference added.