An observational study in Pregnancy Complications and SLE, sponsored by University of Algiers. Recruiting at 2 sites in Algeria. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-12-31.
Sponsored by University of Algiers · Observational
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.
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:
411 studies on the registry are indexed under Pregnancy Complications; 113 are open to participants now.
This study's planned enrollment of 50 is below the median of 400 across 198 observational studies indexed under Pregnancy Complications.
Browse Pregnancy Complications studies →University of Algiers is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
LES was previously diagnosed prior to any conception.
Patients that have had pregnancies history before the diagnosis of LES
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.
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 childbirth
Not enrolling at this site.
Plan to share: Yes — All collected IPD
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
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.
Data sharing details ↗ · drive.google.com
No publications or documents are linked to this record.
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University of Algiers