Endometriosis and Risk of Miscarriage

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

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis; Miscarriage
• Intervention / Treatment: Other: Survey on first pregnancy after endometriosis diagnosis; Other: Survey on first pregnancy

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 844

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All continous women attending endometriosis clinics or undergoing a routine gynecological examination matching the inclusion criteria

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
endometriosis; Survey on first pregnancy after endometriosis diagnosis	Other: Survey on first pregnancy after endometriosis diagnosis; rate of miscarriage was noted
non endometriosis; Survey on first pregnancy	Other: Survey on first pregnancy; rate of miscarriage was noted

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of miscarriage	comparison of rate of miscarriage in the two groups	2 years

Collaborators and Investigators

• Sponsor: Endometriosis Treatment Italian Club
• Collaborators: University of Milan

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 15, 2016
• Primary Completion (ACTUAL): October 4, 2017
• Study Completion (ACTUAL): October 4, 2017

Study Registration Dates

• First Submitted: November 21, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (ACTUAL): November 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 28, 2017
• Last Update Submitted That Met QC Criteria: November 27, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Endometriosis; Abortion, Spontaneous
• Other Study ID Numbers: ETIC001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No