Pregnancies Before the Diagnosis of Systemic Lupus Erythematosus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-55
SponsorUniversity of Algiers
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Collect data on all pregnancies before and after diagnosis of SLE.
Other interventionFor 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Femelle patients at procreation age with diagnosis of LES1 intervention
Trial outcomes
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.
Time frame
The patient will be assessed from the beginning of each pregnancy and in the three month after childbirthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov