Pregnancies Before the Diagnosis of Systemic Lupus Erythematosus (PREDILUP)

University of Algiers

Status: Enrolling

Conditions: Pregnancy Complications; SLE

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

Study type: Observational

Funder types: Other

Identifiers

NCT07148115

LES/PRG/24

Details and patient eligibility

About

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.

Full 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?

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Femelle patients at procreation age with diagnosis of LES

Description:

Patients that have had pregnancies history before the diagnosis of LES

Treatment:

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