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ISRCTN
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ISRCTN95698259
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ClinicalTrials.gov identifier
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Public title
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Randomised double blind controlled trial of single dose methotrexate versus expectant management in women with tubal ectopic pregnancy
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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To assess the efficacy of methotrexate for the non-surgical management of tubal ectopic pregnancies.
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Ethics approval
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Approved by the local research ethics committee in May 2005
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Study design
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Multicentre andomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Tubal ectopic pregnancy
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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15/08/2005
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Anticipated end date
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01/09/2010
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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50 women in each group gives 90% power to detect a difference
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Interventions
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Please note that as of 06/07/10 the duration of this trial has been extended from 01/09/07 to 01/009/10. The trial has also been expanded to include University College Hospital and Leicester Royal Infirmary.
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.
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Primary outcome measure(s)
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The percentage of women successfully treated.
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Secondary outcome measure(s)
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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)
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Sources of funding
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King's College Hospital NHS Trust (UK) - Early Pregnancy and Gynaecology Assessment Unit
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Trial website
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Publications
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Contact name
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Ms
Jackie
Ross
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Address
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Early Pregnancy and Gynaecology Assessment Unit
King's College Hospital
Denmark Hill
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City/town
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London
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Zip/Postcode
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SE5 9RS
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Country
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United Kingdom
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Sponsor
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King's College Hospital NHS Trust (UK)
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Address
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Denmark HIll
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City/town
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London
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Zip/Postcode
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SE5 9RS
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Country
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United Kingdom
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Date applied
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15/08/2005
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Last edited
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07/07/2010
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Date ISRCTN assigned
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21/11/2005
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