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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2005 by Hopital Antoine Beclere.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Hopital Antoine Beclere
ClinicalTrials.gov Identifier:
NCT00137982
First received: August 29, 2005
Last updated: September 7, 2006
Last verified: August 2005
  Purpose
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 Intervention Phase
Tubal Pregnancy
Procedure: Treatment of ectopic pregnancy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hopital Antoine Beclere:

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

Estimated Enrollment: 600
Study Start Date: August 2004
Estimated Study Completion Date: July 2008
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.
  Eligibility

Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137982

Locations
France
Angers Hospital
Angers, France, 49033
Antoine Beclere Hospital
Clamart, France, 92140
Créteil Hospital
Créteil, France, 94000
Franco-Britannique Hospital
Levallois-Perret, France, 92300
Jeanne de Flandre Hospital
Lille, France, 59037
Hôtel Dieu
Lyon, France, 69288
Assistance Publique Hôpitaux de Marseille ; Maternité de la Conception
Marseille, France, 13005
Assistance Publique Hôpitaux de Marseille ; Hôpital Nord
Marseille, France, 13326
Maternité Régionale de Nancy
Nancy, France, 54042
Nantes Hospital
Nantes, France, 44093
Lariboisière Hospital
Paris, France, 75010
Cochin Hospital
Paris, France, 75679
Poissy Saint-Germain-en-Laye Hospital
Poissy, France, 78303
Roubaix Hospital
Roubaix, France, 59100
Charles Nicolle Hospital
Rouen, France, 76031
CMCO
Schiltigheim, France, 67303
Tours Hospital
Tours, France, 37000
Versailles Hospital ; Hôpital André Mignot
Versailles, France, 78157
Sponsors and Collaborators
Hopital Antoine Beclere
Investigators
Study Chair: Fernandez Hervé, PhD MD Hopital Antoine Beclere
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00137982     History of Changes
Other Study ID Numbers: P030409/AOR03040 
Study First Received: August 29, 2005
Last Updated: September 7, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hopital Antoine Beclere:
Ectopic pregnancy
Surgical treatment
Medical treatment
Fertility

Additional relevant MeSH terms:
Pregnancy, Ectopic
Pregnancy, Tubal
Pregnancy Complications

ClinicalTrials.gov processed this record on December 09, 2016