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

Sponsor

Hopital Antoine Beclere (Other)

Overall Status

Unknown status

CT.gov ID

NCT00137982

Collaborator

(none)

600

Enrollment

Locations

Duration (Months)

33.3

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tubal Pregnancy	Procedure: Treatment of ectopic pregnancy	Phase 4

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Aug 1, 2004

Study Completion Date :

Jul 1, 2008

Outcome Measures

Primary Outcome Measures

Subsequent fertility with 2 years follow-up []

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 44 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Angers Hospital	Angers	France	49033
2	Antoine Beclere Hospital	Clamart	France	92140
3	Créteil Hospital	Créteil	France	94000
4	Franco-Britannique Hospital	Levallois-Perret	France	92300
5	Jeanne de Flandre Hospital	Lille	France	59037
6	Hôtel Dieu	Lyon	France	69288
7	Assistance Publique Hôpitaux de Marseille ; Maternité de la Conception	Marseille	France	13005
8	Assistance Publique Hôpitaux de Marseille ; Hôpital Nord	Marseille	France	13326
9	Maternité Régionale de Nancy	Nancy	France	54042
10	Nantes Hospital	Nantes	France	44093
11	Lariboisière Hospital	Paris	France	75010
12	Cochin Hospital	Paris	France	75679
13	Poissy Saint-Germain-en-Laye Hospital	Poissy	France	78303
14	Roubaix Hospital	Roubaix	France	59100
15	Charles Nicolle Hospital	Rouen	France	76031
16	CMCO	Schiltigheim	France	67303
17	Tours Hospital	Tours	France	37000
18	Versailles Hospital ; Hôpital André Mignot	Versailles	France	78157