Exploratory study of a single dose of methotrexate for the treatment of stable tubal ectopic pregnancy

An open label exploratory study to assess the safety of using 100mg of methotrexate as a standard dose treatment for women with unruptured tubal ectopic pregnancy (OSPREY) - OSPREY

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004592-40-GB

Enrollment

Registered

2020-09-29

Start date

2020-11-20

Completion date

Unknown

Last updated

2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ectopic Pregnancy MedDRA version: 20.0 Level: PT Classification code 10014166 Term: Ectopic pregnancy System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions

Interventions

Trade Name: Methotrexate Product Name: Methotrexate Pharmaceutical Form: Injection INN or Proposed INN: Methotrexate CAS Number: 59-05-2 Concentration unit: mg/ml milligram(s)/millilitre Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Clinical decision made for treatment with MTX - Women aged between 18-45 - Serum hCG>15 IU/l - Diagnosis of a mass (=3.5 cm) outside the normal uterine cavity - Body surface area = 1.75 m2 but >= 1.25 m2 - Haemoglobin between 100 and 165g/l within 3 days of treatment - Clinically stable - Able to understand all information and provide written informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: - Clinically significant abnormal haematological/renal/liver indices noted on pre-treatment blood test (within 3 days of treatment) - Significant abdominal pain - Pregnancy of unknown location - Evidence of intrauterine pregnancy - 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 - EP mass on USS of greater than 3.5cm (mean dimensions) - Currently breastfeeding and unwilling to stop

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: To assess outcomes of the 100 mg/ml dose of MTX in patients who routinely would receive 85 mg or lower based on their body surface area. To explore the acceptability of use of 100mg/ml dose of MTX in the management of EP using a high concentration formulation (100 mg/mL) in a pre-filled syringe. ;Primary end point(s): Adverse events Haematological, renal and liver function;Timepoint(s) of evaluation of this end point: This will be assessed on day 4,7,11 and then weekly until the blood pregnancy levels (hCG) return to pre-pregnancy levels. These dates may change according to individual clinical care.	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: To assess outcomes of the 100 mg/ml dose of MTX in patients who routinely would receive 85 mg or lower based on their body surface area. To explore the acceptability of use of 100mg/ml dose of MTX in the management of EP using a high concentration formulation (100 mg/mL) in a pre-filled syringe. ;Primary end point(s): Adverse events Haematological, renal and liver function;Timepoint(s) of evaluation of this end point: This will be assessed on day 4,7,11 and then weekly until the blood pregnancy levels (hCG) return to pre-pregnancy levels. These dates may change according to individual clinical care.

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Secondary

Measure	Time frame
Secondary end point(s): Evidence of rupture Need for surgery Need for a second dose of methotrexate;Timepoint(s) of evaluation of this end point: This will be assessed on day 4,7,11 and then weekly until the blood pregnancy levels (hCG) return to pre-pregnancy levels.	—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026