Randomised double blind controlled trial of single dose methotrexate versus expectant management in women with tubal ectopic pregnancy

Not Applicable

Completed

• Conditions: Tubal ectopic pregnancy; Pregnancy and Childbirth; Ectopic pregnancy

• Registration Number: ISRCTN95698259
• Lead Sponsor: King's College Hospital NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-21
• Last Update Posted: 18 April 2017

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

1. Certain ultrasound diagnosis of tubal ectopic pregnancy
2. Clinically stable patient with no evidence of haematoperitoneum on ultrasound scan
3. Non-viable pregnancy
4. No history of liver or renal disease
5. Normal red and white cell count, renal and liver function tests
6. Inital serum human Chorionic Gonadotropin (hCG) less than 1500 IU/l
7. Written informed consent

Exclusion Criteria

1. Haemodynamic instability
2. Severe pain
3. History renal/liver/pulmonary disease
4. Blood dyscrasia
5. Haematoperitoneum
6. Foetal heart present
7. Written informed consent declined

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of women successfully treated.

Secondary Outcome Measures

Name	Time	Method
1. Complications such as tubal rupture, pain and the need for emergency surgery<br>2. Length of time followed up (i.e. time for beta-hCG to fall to below 20 IU/l)