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

Hopital Antoine Beclere

Status and phase: Unknown; Phase 4

Conditions: Tubal Pregnancy

Treatments: Procedure: Treatment of ectopic pregnancy

Study type: Interventional

Funder types: Other

Identifiers

NCT00137982

P030409/AOR03040

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 44 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)