A study to assess the safety of using 100 mg methotrexate for the treatment of an unruptured ectopic pregnancy
| ISRCTN | ISRCTN75251780 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75251780 |
| ClinicalTrials.gov (NCT) | Nil Known |
| Clinical Trials Information System (CTIS) | 2020-004592-40 |
| Integrated Research Application System (IRAS) | 285725 |
| Protocol serial number | Nil Known |
| Sponsor | Accord (United Kingdom) |
| Funder | Nordic Pharma Group |
- Submission date
- 23/10/2025
- Registration date
- 28/11/2025
- Last edited
- 28/11/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
We will explore the feasibility of giving women who have a stable, ectopic pregnancy (a pregnancy that has implanted in the Fallopian tube and not the uterus) a single dose of methotrexate of 100 mg/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 60 and 120 mg). 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.
Who can participate?
Women aged between 18-45 years who have a stable ectopic pregnancy
What does the study involve?
Participants are given a standard one-off dose of methotrexate of 100 mg/ml. All of the women recruited to the study would normally have received less than 100 mg 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 (published historical data).
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
The study will be carried out at the Pregnancy Support Centre within the Royal Infirmary of Edinburgh, NHS Lothian (UK)
When is the study starting and how long is it expected to run for?
November 2020 to June 2023
Who is funding the study?
Nordic Pharma Group
Who is the main contact?
Ann Doust, ann.doust@ed.ac.uk
Contact information
Public
IRR South, CRH, 4 Little France Drive
Edinburgh
EH16 4UU
United Kingdom
 ORCID ID |
0000-0001-8726-7186 |
|---|---|
| Phone | +44 (0)7810643488 |
| ann.doust@ed.ac.uk |
Scientific
IRR South, CRH, 4 Little France Drive
Edinburgh
EH16 4UU
United Kingdom
| ORCID ID |
0000-0002-7170-5740 |
|---|---|
| Phone | +44 (0)131 651 8321 |
| w.c.duncan@ed.ac.uk |
Principal investigator
IRR South, CRH, 4 Little France Drive
Edinburgh
EH16 4UU
United Kingdom
| ORCID ID |
0000-0002-9656-493X |
|---|---|
| Phone | +44 (0)131 651 8321 |
| andrew.horne@ed.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-site open-label exploratory study |
| Secondary study design | Non randomised study |
| Participant information sheet | 48267_PIS_V3_18Jun21.pdf |
| Scientific title | OSPREY: 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 |
| Study acronym | OSPREY |
| Study objectives | To explore the safety of 100 mg/ml dose of MTX in patients who routinely would receive 85 mg or lower based on their body surface area. |
| Ethics approval(s) |
Approved 20/11/2020, Health & Social Care Research Ethics Committee A (HSC REC A) (Office for Research Ethics Committees Northern Ireland (ORECNI) Customer Care & Performance Directorate Lissue Industrial Estate West 5 Rathdown Walk Moira Road, Lisburn, BT28 2RF, United Kingdom; +44 (0)28 95361407; RECA@hscni.net), ref: 20/NI/0136 |
| Health condition(s) or problem(s) studied | Ectopic pregnancy |
| Intervention | 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. |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Methotrexate |
| Primary outcome measure(s) |
Safety endpoint: |
| Key secondary outcome measure(s) |
1. Time to resolution of ectopic pregnancy (number of days from treatment with methotrexate until serum hCG) |
| Completion date | 30/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Female |
| Target sample size at registration | 10 |
| Total final enrolment | 10 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 26/07/2021 |
| Date of final enrolment | 31/05/2023 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
2-4 Waterloo Place
Edinburgh
EH1 3EG
Scotland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 3 | 18/06/2021 | 28/10/2025 | No | Yes |
| Protocol file | version 2 | 17/06/2021 | 28/10/2025 | No | No |
Additional files
- 48267_PIS_V3_18Jun21.pdf
- Participant information sheet
- 48267_PROTOCOL_V2_17Jun2021.pdf
- Protocol file
Editorial Notes
23/10/2025: Study's existence confirmed by the Health & Social Care Research Ethics Committee A (HSC REC A).
