Pregnancies Before the Diagnosis of Systemic Lupus Erythematosus

NCT07148115 | Recruiting

• 1 other identifier: LES/PRG/24
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pregnancy Complications; SLE

Keywords

Pregnancy; SLE; Obstetrical events

Outcome Measures

Primary Outcomes (1)

• 1. Primary outcome: Prevalence of obstetrical events before the diagnosis of SLE. Secondary outcome: 1. Assess the severity of the disease at the time of LES diagnosis. 2. Compare the outcomes of pregnancies before and after the LES

  * Evaluate the number of pregnancies for each woman before and after the diagnosis of lupus. * Assess obstetric events for each pregnancy (spontaneous abortion, prematurity, fetal death, pre-eclampsia, HELLP syndrome, or other pregnancy-related events). * Assess the presence of systemic signs during pregnancy or the postpartum period. * Collect data on the baby's status, including weight, height, and any morbid conditions (dermatological, cardiac, respiratory, etc.). * Note the timeframe between the last pregnancy or delivery and the SLE diagnosis.

  The patient will be assessed from the beginning of each pregnancy and in the three month after childbirth

Study Arms (1)

Femelle patients at procreation age with diagnosis of LES

Patients that have had pregnancies history before the diagnosis of LES

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

Interventions

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

Femelle patients at procreation age with diagnosis of LES

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Only biological femelle sex and cis-gender people that have experienced pregnancy are eligible to participate to the study
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Eligible patients for the study are selected from all women diagnosed with lupus erythematosus in the Department of Internal Medicine at the Ain-Taya Teaching Hospital from 2000 to 2025. Patients are recruited from primary care, emergency units, or the gynecology and obstetrics department. These patients are being followed up in the Department of Internal Medicine at Ain-Taya Hospital.

You may qualify if:

• 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.

You may not qualify if:

• LES was previously diagnosed prior to any conception.

Sponsors & Collaborators

• University of Algiers: lead

Study Sites (2)

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

Aïn Taya, Algiers Province, 16019, Algeria

ACTIVE NOT RECRUITING

Ain-Taya's Public Hospital

Algiers, 16019, Algeria

RECRUITING

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Wafia-Nadia Nibouche-Hattab, Professor of medicine

  University of Algiers. Faculty of medicine

  STUDY DIRECTOR

Central Study Contacts

Wafia- Nadia Nibouche - Hattab, Professor in medicine

CONTACT

+213-771-810-932; wani16000@yahoo.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 29, 2025
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: April 30, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: One month after the end of the study, presumely in March 2026 until Avril 2026
• Access Criteria: the reviewers board of journal if manuscript is accepted. they will be able to access all data collected and statistical study.

Locations

AL (2)