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?
Kings 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?
Kings College Hospital Early Pregnancy Unit (UK).
Who is the main contact?
Jackie Ross
Consultant Gynaecologist c/o Early Pregnancy Unit Kings College Hospital
Tel.: 02032991702
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Randomised double blind controlled trial of single dose methotrexate versus expectant management in women with tubal ectopic pregnancy
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
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
2017 results in https://www.ncbi.nlm.nih.gov/pubmed/27731538