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Clinical Trials/NCT03354793
NCT03354793
Completed
Not Applicable

Impact of Endometriosis on the Risk of Obstetric Complications in Spontaneous Pregnancy: a Multicentric Italian Study

Endometriosis Treatment Italian Club0 sites844 target enrollmentJanuary 15, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endometriosis
Sponsor
Endometriosis Treatment Italian Club
Enrollment
844
Primary Endpoint
Pre-term delivery
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The aim of this study is to compare the rate of obstetric complications at first spontaneous pregnancy among women with endometriosis, with the rate of obstetric complications at first spontaneous pregnancy among women without endometriosis

Detailed Description

All women followed up for a surgical or clinical/sonographic diagnosis of endometriosis in 11 italian referral Centres for the treatment of endometriosis, completed a questionnaire regarding their previous pregnancies. The same questionnaire was completed by women, attending a routine gynecologic visit, in whom surgery or clinical/sonographic evaluation excluded endometriosis.

Registry
clinicaltrials.gov
Start Date
January 15, 2016
End Date
October 4, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Endometriosis Treatment Italian Club
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 30 to 50 years old women with at least one previous spontaneous pregnancy \> 12 weeks with surgical or clinical/sonographic diagnosis of endometriosis or in whom surgical or clinical/sonographic evaluation ruled out endometriosis

Exclusion Criteria

  • Pregnancy achieved by assisted reproductive techniques
  • Pregnancy terminated before 12 gestational weeks
  • Twin pregnancy
  • Preexisting hypertension
  • Lupus like anti-coagulant
  • Non corrected uterine malformation
  • Recurrent abortion

Outcomes

Primary Outcomes

Pre-term delivery

Time Frame: 2 years

comparison of rate of preterm delivery in the two groups

Secondary Outcomes

  • Placenta praevia(2 years)

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