Endometriosis and Risk of Miscarriage

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03354780
• Other study ID #: ETIC001
• 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 miscarriage at first spontaneous pregnancy among women with endometriosis with the rate of miscarriage at first spontaneous pregnancy among women without endometriosis.

Description:

All women followed up for a surgical or 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 vaginal examination and pelvic ultrasonography excluded endometriosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 844
• Est. completion date: October 4, 2017
• Est. primary completion date: October 4, 2017
• Accepts healthy volunteers: No
• 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

• 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 technology

• Biochemical pregnancy

• Non corrected uterine malformation, poliabortivity, lupus like anticoagulant

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Endometriosis
• Miscarriage

Intervention

Other:
• Survey on first pregnancy after endometriosis diagnosis
rate of miscarriage was noted
• Survey on first pregnancy
rate of miscarriage was 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
Primary	Rate of miscarriage	comparison of rate of miscarriage in the two groups	2 years