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OpenTrials
Completed

NCT Number: NCT03354793

Endometriosis and Risk of Obstetric Complications

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

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Pregnancy Complications Urogenital Diseases

Age range

30 year–50 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey on first pregnancy after endometriosis diagnosis

Other

Obstetric complications were noted

Survey on first pregnancy

Other

Obstetric complications were noted

Primary outcomes

  1. Pre-term delivery

    Time frame: 2 years

    comparison of rate of preterm delivery in the two groups

Secondary outcomes

  1. Placenta praevia

    Time frame: 2 years

    comparison of rate of placenta praevia in the two groups

Other outcomes

  1. Intra uterine Growth Restriction

    Time frame: 2 years

    comparison of rate of IUGR fetuses in the two groups

  2. HELLP syndrome

    Time frame: 2 years

    comparison of rate of HELLP syndrome in the two groups

Sponsors and collaborators

Lead sponsor

Endometriosis Treatment Italian Club

Other

Collaborators

  • University of Milan

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 28, 2017
Registry last updated
Nov 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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