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Pregnancies Before the Diagnosis of Systemic Lupus Erythematosus

NCT ID: NCT07148115

Last Updated: 2025-12-31

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

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-04-30

Brief Summary

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This is an observational, monocentric, retrospective cohort study. Its primary objective is to examine maternal and foetal outcomes in pregnancies that occurred before the diagnosis of systemic lupus erythematosus (SLE) in a group of female participants who were subsequently diagnosed with the condition.

Detailed Description

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The investigators aim to study obstetrical and systemic signs in participants' pregnancies prior to an SLE diagnosis. Information will be collected from medical records and by asking participants questions during medical visits. The diagnosis of SLE is made using the ACR 1997 criteria. It is also based on renal histological findings.

The study must answer three questions:

1. Are systemic signs of SLE present before or during pregnancy?
2. What were the fetal and maternal outcomes after or during each pregnancy? What is/was the severity of SLE after diagnosis?

Conditions

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Pregnancy Complications SLE

Keywords

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Pregnancy SLE Obstetrical events

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Femelle patients at procreation age with diagnosis of LES

Patients that have had pregnancies history before the diagnosis of LES

Collect data on all pregnancies before and after diagnosis of SLE.

Intervention Type OTHER

For participants who are still alive, data are collected from interviews with patients using a prepared questionnaire that asks about all pregnancies and obstetrical events prior to the diagnosis of SLE.

For deceased patients, data are taken from the medical records of obstetrical events.

Data will be collected on anthropometric, biological, immunological, and histological features before and after the diagnosis of SLE, if available.

The activity and severity of the disease after diagnosis will be assessed using the recommended tools.

Interventions

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Collect data on all pregnancies before and after diagnosis of SLE.

For participants who are still alive, data are collected from interviews with patients using a prepared questionnaire that asks about all pregnancies and obstetrical events prior to the diagnosis of SLE.

For deceased patients, data are taken from the medical records of obstetrical events.

Data will be collected on anthropometric, biological, immunological, and histological features before and after the diagnosis of SLE, if available.

The activity and severity of the disease after diagnosis will be assessed using the recommended tools.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women of childbearing age with a history of at least one pregnancy
* Pregnancy occurred before the diagnosis of LES.
* LES was diagnosed after at least one pregnancy.
* The subject is classified as having LES according to the 1997 ACR or EULAR 2019 criteria.

Exclusion Criteria

LES was previously diagnosed prior to any conception.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Algiers

OTHER

Sponsor Role lead

Responsible Party

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W.N. Nibouche-Hattab

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wafia-Nadia Nibouche-Hattab, Professor of medicine

Role: STUDY_DIRECTOR

University of Algiers. Faculty of medicine

Locations

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Department of internal medicine, Ain-Taya's teaching Public hospital

Aïn Taya, Algiers Province, Algeria

Site Status ACTIVE_NOT_RECRUITING

Ain-Taya's Public Hospital

Algiers, , Algeria

Site Status RECRUITING

Countries

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Algeria

Central Contacts

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Wafia- Nadia Nibouche - Hattab, Professor in medicine

Role: CONTACT

Phone: +213-771-810-932

Email: [email protected]

Facility Contacts

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Wafia Nadia WN Nibouche-Hattab, MD

Role: primary

Other Identifiers

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LES/PRG/24

Identifier Type: -

Identifier Source: org_study_id