Evaluation of Therapeutic Strategies for Treatment of Ectopic Pregnancies (EP) and Evaluation of Subsequent Fertility

Tubal Pregnancy Clinical Trial

Official title: Prospective Study, Randomized Controlled Trial Between Medical Treatment by Methotrexate Versus Conservative Surgical Treatment (Group 1) and Conservative Versus Radical Surgical Treatment (Group 2) to Evaluate Subsequent Fertility

Status Recruiting

Clinical Trial Summary

Three protocols are used to treat ectopic pregnancies: medical treatment by methotrexate, conservative surgery or radical surgery. There are no data about subsequent fertility except in a cohort study. The investigators propose to evaluate the true subsequent fertility with a follow-up of 2 years, in a randomized controlled trial.

Clinical Trial Description

The first group includes non active ectopic pregnancies defined by score or algorithm. In this case, we propose a randomized controlled trial between medical and conservative surgery. In all others clinical situations, we proposed surgery treatment. In a randomized controlled trial we compare conservative versus radical treatment. The patients are followed-up during 2 years with phone contact every 6 months. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy, Ectopic
• Tubal Pregnancy

• NCT number: NCT00137982
• Study type: Interventional
• Source: Hopital Antoine Beclere
• Contact: Fernandez Hervé, PhD MD
• Phone: +33 1 45 37 44 69
• Email: herve.fernandez@abc.aphp.fr
• Status: Recruiting
• Phase: Phase 4
• Start date: August 2004
• Completion date: July 2008