OSPREY
Research type
Research Study
Full title
An open label exploratory study to assess the safety of using 100mg of methotrexate as a standard dose treatment for women with unruptured ectopic pregnancy (OSPREY)
IRAS ID
285725
Contact name
Andrew Horne
Contact email
Sponsor organisation
University of Edinburgh
Eudract number
2020-004592-40
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
We will explore the feasibility of giving women who have a stable, tubal ectopic pregnancy (a pregnancy that has implanted in the Fallopian tube and not the uterus) a single dose of methotrexate of 100mg/ml. Methotrexate is a drug used to treat ectopic pregnancies and is usual standard care when a patient presents in a stable condition. The dose is calculated depending on the patient's body surface area (calculated using height and weight). The differing doses then have to be prepared in pharmacies (these range between 60mgs and 120mg). This adds to waiting times and burden on patients. The aim of this study is to find out whether we can safely give all women a standard dose. We will recruit women who have a stable ectopic pregnancy and give then a standard one-off dose of methotrexate of 100mg/ml. All of the women recruited to the study would normally have received less than 100mgs of methotrexate had they received standard care. We will follow them up as per usual clinical care (no extra visits) until the pregnancy resolves. We will look at side effects experienced by these women and compare these to side effects experienced by the women who are given a slightly lower dose (historical data).
REC name
HSC REC A
REC reference
20/NI/0136
Date of REC Opinion
20 Nov 2020
REC opinion
Further Information Favourable Opinion