Endometriosis and Risk of Obstetric Complications

Completed

• Conditions: Endometriosis; Pregnancy Complications
• Interventions: Other: Survey on first pregnancy; Other: Survey on first pregnancy after endometriosis diagnosis

• Registration Number: NCT03354793
• Lead Sponsor: Endometriosis Treatment Italian Club

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.

Study Timeline

• Study Start: 2016-01-15
• Primary Completion: 2017-10-04
• Study Completion: 2017-10-04
• Status Verified: 2017-11
• Study First Submitted: 2017-11-21
• Study First Submitted QC: 2017-11-27
• Last Update Submitted: 2017-11-27
• Study First Posted: 2017-11-28
• Last Update Posted: 2017-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 844

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non endometriosis	Survey on first pregnancy	Survey on first pregnancy
endometriosis	Survey on first pregnancy after endometriosis diagnosis	Survey on first pregnancy after endometriosis diagnosis

Primary Outcome Measures

Name	Time	Method
Pre-term delivery	2 years	comparison of rate of preterm delivery in the two groups

Secondary Outcome Measures

Name	Time	Method
Placenta praevia	2 years	comparison of rate of placenta praevia in the two groups