MedDataX Logo

Endometriosis and Risk of Obstetric Complications

NCT ID: NCT03354793

Last Updated: 2017-11-28

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

844 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-15

Study Completion Date

2017-10-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometriosis Pregnancy Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

endometriosis

Survey on first pregnancy after endometriosis diagnosis

Survey on first pregnancy after endometriosis diagnosis

Intervention Type OTHER

Obstetric complications were noted

non endometriosis

Survey on first pregnancy

Survey on first pregnancy

Intervention Type OTHER

Obstetric complications were noted

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Survey on first pregnancy after endometriosis diagnosis

Obstetric complications were noted

Intervention Type OTHER

Survey on first pregnancy

Obstetric complications were noted

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Milan

OTHER

Sponsor Role collaborator

Endometriosis Treatment Italian Club

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nicola Berlanda, MD

Role: PRINCIPAL_INVESTIGATOR

Endometriosis Treatment Italian Club

References

Explore related publications, articles, or registry entries linked to this study.

Berlanda N, Alio W, Angioni S, Bergamini V, Bonin C, Boracchi P, Candiani M, Centini G, D'Alterio MN, Del Forno S, Donati A, Dridi D, Incandela D, Lazzeri L, Maiorana A, Mattei A, Ottolina J, Orenti A, Perandini A, Perelli F, Piacenti I, Pino I, Porpora MG, Scaramuzzino S, Seracchioli R, Solima E, Somigliana E, Venturella R, Vercellini P, Vigano P, Vignali M, Zullo F, Zupi E; Endometriosis Treatment Italian Club (ETIC). Impact of endometriosis on obstetric outcome after natural conception: a multicenter Italian study. Arch Gynecol Obstet. 2022 Jan;305(1):149-157. doi: 10.1007/s00404-021-06243-z. Epub 2021 Oct 8.

Reference Type DERIVED
PMID: 34623489 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ETIC002

Identifier Type: -

Identifier Source: org_study_id