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Endometriosis and Risk of Obstetric Complications

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ClinicalTrials.gov Identifier: NCT03354793
Recruitment Status : Completed
First Posted : November 28, 2017
Last Update Posted : November 28, 2017
Sponsor:
Collaborator:
University of Milan
Information provided by (Responsible Party):
Endometriosis Treatment Italian Club

Brief 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

Condition or disease Intervention/treatment
Endometriosis Pregnancy Complications Other: Survey on first pregnancy after endometriosis diagnosis Other: Survey on first pregnancy

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.

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Study Type : Observational
Actual Enrollment : 844 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of Endometriosis on the Risk of Obstetric Complications in Spontaneous Pregnancy: a Multicentric Italian Study
Actual Study Start Date : January 15, 2016
Actual Primary Completion Date : October 4, 2017
Actual Study Completion Date : October 4, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

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




Primary Outcome Measures :
  1. Pre-term delivery [ Time Frame: 2 years ]
    comparison of rate of preterm delivery in the two groups


Secondary Outcome Measures :
  1. Placenta praevia [ Time Frame: 2 years ]
    comparison of rate of placenta praevia in the two groups


Other Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes 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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354793


Sponsors and Collaborators
Endometriosis Treatment Italian Club
University of Milan
Investigators
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Principal Investigator: Nicola Berlanda, MD Endometriosis Treatment Italian Club
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Responsible Party: Endometriosis Treatment Italian Club
ClinicalTrials.gov Identifier: NCT03354793    
Other Study ID Numbers: ETIC002
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometriosis
Pregnancy Complications
Genital Diseases, Female