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.

Phase 1

• Conditions: Ectopic pregnancy; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy

• Registration Number: ACTRN12607000113459
• Lead Sponsor: Associate Professor George Condous

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-02-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 400

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is successful conservative (non-surgical) management of ectopic pregnancy. This is defined as successful resolution of the pregnancy measured by a decrease in serum hCG levels to less than 15 IU/L without the need for surgical intervention, whether after treatment with methotrexate or just expectant management.[Serum hCG measurements will be performed every week following implementation of the conservative management strategies. The weekly measurements will continue until the serum hCG levels are less than 15 IU/L; this could take as little as 14 days or as long as 65 days and depends on the starting serum hCG level.]