ACTRN12607000113459
Not yet recruiting
Phase 1
A randomised phase III study to evaluate the effects of methotrexate in the treatment of women with an ectopic pregnancy to prevent the need for surgical intervention.
Associate Professor George Condous0 sites400 target enrollmentFebruary 8, 2007
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Ectopic pregnancy
- Sponsor
- Associate Professor George Condous
- Enrollment
- 400
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pre\-menopausal women • Asymptomatic• Haemodynamically stable• Serum human chorionic gonadotrophin level (hCG) less than 3000 IU/L• No haemoperitoneum• Absence of fetal cardiac activity on TVS• No contraindication to the use of methotrexate• Normal liver and renal function.
Exclusion Criteria
- •In pain• Haemodynamically unstable• Serum hCG \> 3000 IU/L• Haemoperitoneum on TVS• Fetal cardiac activity on TVS• Co\-existing intrauterine pregnancy• Contraindication to the use of methotrexate• Abnormal liver or kidney function• Unable to attend for follow up clinic visits• Learning difficulties, patients under the age of 18 and other vulnerable groups, e.g. mental illness, dementia due to issues regarding informed consent.
Outcomes
Primary Outcomes
Not specified
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