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

Phase 4

• Conditions: Tubal Pregnancy

• Registration Number: NCT00137982
• Lead Sponsor: Hopital Antoine Beclere

Brief 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.

Detailed 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 Timeline

• Study Start: 2004-08
• Status Verified: 2005-08
• Study First Submitted: 2005-08-29
• Study First Submitted QC: 2005-08-29
• Study First Posted: 2005-08-30
• Last Update Submitted: 2006-09-07
• Last Update Posted: 2006-09-08
• Study Completion: 2008-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

• Diagnosis by ultra sound of ectopic pregnancy (EP)
• Patients aged > 18 years old
• Desire of future pregnancy

Exclusion Criteria

• EP by failure of contraception
• EP associated with in vitro fertilization (IVF)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Subsequent fertility with 2 years follow-up

Secondary Outcome Measures

Name	Time	Method
Complications of treatments
Time of hospitalisation
Decrease curve of beta-hCG after treatment
Success rate in each group

Trial Locations

Locations (18)

CMCO; 🇫🇷 Schiltigheim, France

Roubaix Hospital; 🇫🇷 Roubaix, France

Charles Nicolle Hospital; 🇫🇷 Rouen, France

Angers Hospital; 🇫🇷 Angers, France

Créteil Hospital; 🇫🇷 Créteil, France

Franco-Britannique Hospital; 🇫🇷 Levallois-Perret, France

Jeanne de Flandre Hospital; 🇫🇷 Lille, France

Maternité Régionale de Nancy; 🇫🇷 Nancy, France

Nantes Hospital; 🇫🇷 Nantes, France

Poissy Saint-Germain-en-Laye Hospital; 🇫🇷 Poissy, France

Lariboisière Hospital; 🇫🇷 Paris, France

Antoine Beclere Hospital; 🇫🇷 Clamart, France

Assistance Publique Hôpitaux de Marseille ; Hôpital Nord; 🇫🇷 Marseille, France

Versailles Hospital ; Hôpital André Mignot; 🇫🇷 Versailles, France

Assistance Publique Hôpitaux de Marseille ; Maternité de la Conception; 🇫🇷 Marseille, France

Hôtel Dieu; 🇫🇷 Lyon, France

Cochin Hospital; 🇫🇷 Paris, France

Tours Hospital; 🇫🇷 Tours, France