Pregnancies Before the Diagnosis of Systemic Lupus Erythematosus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Collect data on all pregnancies before and after diagnosis of SLE..
- Who it may be relevant to
- Registry conditions: Pregnancy Complications, SLE. Basic parameters: 18 years — 55 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Algeria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pregnancy Outcomes Prior to a Systemic Lupus Erythematosus Diagnosis
Overview
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?
Interventions
- 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 wi
Primary outcome measures
- 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 [Time frame: The patient will be assessed from the beginning of each pregnancy and in the three month after childbirth]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Algeria · 2 centers
- Department of internal medicine, Ain-Taya's teaching Public hospital — Aïn Taya
- Ain-Taya's Public Hospital — Algiers
Identifiers
NCT: NCT07148115 · LES/PRG/24