Endometriosis and Obstetric Outcomes

NCT ID: NCT04664660

Last Updated: 2020-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-10

Study Completion Date

2021-03-01

Brief Summary

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The purpose of this study is to assess if endometriosis can be considered a risk factor for adverse obstetric and delivery outcomes

Detailed Description

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This is a retrospective, observational, case-control study. Pregnancy, delivery and neonatal outcomes will be analyzed in two groups of patients (case and control group): women with diagnosis of endometriosis histologically confirmed and women without endometriosis. Women with endometriosis will be matched to controls by age. A database with general medical and gynecological history, pregnancy course, delivery mode and newborn conditions will be analyzed.

Conditions

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Endometriosis Obstetric Complication

Keywords

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Endometriosis Obstetric outcome Delivery outcome Neonatal outcome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with previous histologic diagnosis of endometriosis

Retrospective analysis of obstetrics outcomes

Intervention Type OTHER

Retrospective analysis of clinical records including general medical and gynecological history, pregnancy course, delivery mode and newborn conditions.

Patient without endometriosis

Retrospective analysis of obstetrics outcomes

Intervention Type OTHER

Retrospective analysis of clinical records including general medical and gynecological history, pregnancy course, delivery mode and newborn conditions.

Interventions

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Retrospective analysis of obstetrics outcomes

Retrospective analysis of clinical records including general medical and gynecological history, pregnancy course, delivery mode and newborn conditions.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pregnant women who delivered at Azienda Ospedaliero Universitaria Policlinico di Modena from 2000 to 2020
* Histologic diagnosis of endometriosis before pregnancy for case group
* Age matched healthy patients for control group

Exclusion Criteria

* Clinical records not available
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero-Universitaria di Modena

OTHER

Sponsor Role lead

Responsible Party

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Carlo Alboni, MD, PhD

Dr. Carlo Alboni MD, PhD Head of Minimally Invasive and Robotic Gynecologic Surgery Unit University Hospital of Modena - Italy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Carlo Alboni

Modena, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Carlo Alboni

Role: CONTACT

Phone: 0594224387

Email: [email protected]

Facility Contacts

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Carlo Alboni, MD, PhD

Role: primary

Other Identifiers

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EndoPreg01

Identifier Type: -

Identifier Source: org_study_id