Endometriosis and Risk of Obstetric Complications

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03354793
• Other study ID #: ETIC002
• Status: Completed
• Phase: N/A
• First received: November 21, 2017
• Last updated: November 27, 2017
• Start date: January 15, 2016
• Est. completion date: October 4, 2017

Study information

• Verified date: November 2017
• Source: Endometriosis Treatment Italian Club
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 844
• Est. completion date: October 4, 2017
• Est. primary completion date: October 4, 2017
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis
• Pregnancy Complications

Intervention

Other:
• Survey on first pregnancy after endometriosis diagnosis
Obstetric complications were noted
• Survey on first pregnancy
Obstetric complications were noted

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Endometriosis Treatment Italian Club	University of Milan

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intra uterine Growth Restriction	comparison of rate of IUGR fetuses in the two groups	2 years
Other	HELLP syndrome	comparison of rate of HELLP syndrome in the two groups	2 years
Primary	Pre-term delivery	comparison of rate of preterm delivery in the two groups	2 years
Secondary	Placenta praevia	comparison of rate of placenta praevia in the two groups	2 years