Condition category
Pregnancy and Childbirth
Date applied
15/08/2005
Date assigned
21/11/2005
Last edited
05/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
It is not known whether methotrexate is needed to treat ectopic pregnancies (when a fertilised egg implants itself outside of the womb) with relatively low hormone levels. This study aims to see whether patients need methotrexate or whether these ectopic pregnancies get better without any treatment.

Who can participate?
Women with mild symptoms, an ectopic pregnancy seen on ultrasound scan (without a heartbeat or internal bleeding) and a blood test showing human chorionic gonadotropin (hCG) hormone levels less than 1500 IU/l.

What does the study involve?
Participants will be randomly allocated to have an injection of either methotrexate or water (you will not know which you get and neither will your doctor), then will have their blood levels of hCG monitored to see if the ectopic pregnancy gets better.

What are the possible benefits and risks of participating?
The results of this study will help us to work out what is the best treatment strategy. The risks are the treatment may not work, whether you get the methotrexate or not, and this will means having an operation to remove the ectopic pregnancy.

Where is the study run from?
King’s College Hospital and University College Hospital, London (UK).

When is the study starting and how long is it expected to run for?
The study started in August 2005 and is expected to run until September 2014.

Who is funding the study?
King’s College Hospital Early Pregnancy Unit (UK).

Who is the main contact?
Jackie Ross
Consultant Gynaecologist c/o Early Pregnancy Unit King’s College Hospital
Tel.: 02032991702

Trial website

Contact information

Type

Scientific

Primary contact

Ms Jackie Ross

ORCID ID

Contact details

Early Pregnancy and Gynaecology Assessment Unit
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

To assess the efficacy of methotrexate for the non-surgical management of tubal ectopic pregnancies.

On 06/07/2010, the anticipated end date was changed from 01/09/2007 to 01/09/2010. The trial has also been expanded to include University College Hospital and Leicester Royal Infirmary.

On 13/09/2013, the anticipated end date was changed from 01/09/2010 to 01/09/2014 and the target number of participants was changed from "50 women in each group gives 90% power to detect a difference" to "35 women in each group gives 80% power to detect a difference."

As of 05/06/2014 the study has completed recruitment and is in the data analysis phase.

Ethics approval

Approved by the local research ethics committee in May 2005

Study design

Multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Tubal ectopic pregnancy

Intervention

Women who fulfill the inclusion criteria and have normal blood results will be randomised to methotrexate treatment or placebo. Those having methotrexate will be given a single dose 50 mg/m^2. Women randomised to placebo will be given an injection of 1 ml of normal saline intra-muscularly. All women will be managed on an outpatient basis and attend for a serum hCG measurement in 96 hours. Provided patients are clinically stable they will attend for another blood test 72 hours later. The treatment failure will be defined as a rise in serum hCG greater than 15% on two consecutive measurements.

Intervention type

Drug

Phase

Not Specified

Drug names

Methotrexate

Primary outcome measures

The percentage of women successfully treated.

Secondary outcome measures

1. Complications such as tubal rupture, pain and the need for emergency surgery
2. Length of time followed up (i.e. time for beta-hCG to fall to below 20 IU/l)

Overall trial start date

15/08/2005

Overall trial end date

01/09/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Certain ultrasound diagnosis of tubal ectopic pregnancy
2. Clinically stable patient with no evidence of haematoperitoneum on ultrasound scan
3. Non-viable pregnancy
4. No history of liver or renal disease
5. Normal red and white cell count, renal and liver function tests
6. Inital serum human Chorionic Gonadotropin (hCG) less than 1500 IU/l
7. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

35 women in each group gives 80% power to detect a difference

Participant exclusion criteria

1. Haemodynamic instability
2. Severe pain
3. History renal/liver/pulmonary disease
4. Blood dyscrasia
5. Haematoperitoneum
6. Foetal heart present
7. Written informed consent declined

Recruitment start date

15/08/2005

Recruitment end date

01/09/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Early Pregnancy and Gynaecology Assessment Unit
London
SE5 9RS
United Kingdom

Sponsor information

Organisation

King's College Hospital NHS Trust (UK)

Sponsor details

Denmark HIll
London
SE5 9RS
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Hospital/treatment centre

Funder name

King's College Hospital NHS Trust (UK) - Early Pregnancy and Gynaecology Assessment Unit

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes