Ectopic pregnancy Pregnancy and Childbirth
Conditions
Interventions
Osprey is a single-site open-label exploratory study of the safety and outcomes of using a pre-prepared single dose of 100 mg/ml MTX given via an IM injection in women with a stable EP.
Sponsors
Accord (United Kingdom)
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Clinical decision made for treatment with MTX 2. Women aged between 18-45 years 3. Serum hCG >15 IU/l 4. Diagnosis of an ectopic pregnancy/pregnancy of unknown location 5. Body surface area =1.75 m2 but =1.25 m2 6. Haemoglobin between 100 and 165g/l within 3 days of treatment 7. Clinically stable e.g. no abdominal guarding or rigidity on examination and no evidence significant of intra-abdominal bleeding on USS 8. Able to understand all information and provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Clinically significant abnormal haematological/renal/liver indices noted on pre-treatment blood test (within 3 days of treatment) 2. Significant abdominal pain 3. Evidence of intrauterine pregnancy 4. Evidence of significant intra-abdominal bleed on USS defined by echogenic free fluid above the uterine fundus or surrounding ovary within 1 day of treatment 5. EP mass on USS of greater than 3.5 cm (mean dimensions) which is deemed not suitable for treatment with MTX 6. Currently breastfeeding and unwilling to stop
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety endpoint: 1. Incidence of related adverse events measured from baseline until resolution of ectopic pregnancy 2. Changes to blood haemotological, renal and liver function tests measured at baseline, day 4 and day 7 post treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to resolution of ectopic pregnancy (number of days from treatment with methotrexate until serum hCG) 2. Treatment failure (requirement for second injection of methotrexate or requirement for surgical intervention) Timelines for both measures were variable across participants | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactAnn Doust
Outcome results
None listed