Endometriosis and Risk of Obstetric Complications

November 27, 2017 updated by: Endometriosis Treatment Italian Club

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

844

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All continuous 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 > 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
endometriosis
Survey on first pregnancy after endometriosis diagnosis
Other: Survey on first pregnancy after endometriosis diagnosis
Obstetric complications were noted
non endometriosis
Survey on first pregnancy
Other: Survey on first pregnancy
Obstetric complications were noted

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-term delivery
Time Frame: 2 years
comparison of rate of preterm delivery in the two groups
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Placenta praevia
Time Frame: 2 years
comparison of rate of placenta praevia in the two groups
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra uterine Growth Restriction
Time Frame: 2 years
comparison of rate of IUGR fetuses in the two groups
2 years
HELLP syndrome
Time Frame: 2 years
comparison of rate of HELLP syndrome in the two groups
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endometriosis Treatment Italian Club

Collaborators

University of Milan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • ETIC002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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