NCT07148115

Pregnancies Before the Diagnosis of Systemic Lupus Erythematosus

Pregnancy Outcomes Prior to a Systemic Lupus Erythematosus Diagnosis

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: University of Algiers · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Pregnancy Complications
• SLE

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-12-31
• Completion: 2026-04-30
• First posted: 2025-08-29
• Last updated: 2025-12-31

Locations

2 sites across 1 country: Algeria