Pregnancy Complications, SLE
Conditions
Keywords
Pregnancy, SLE, Obstetrical events
Brief 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?
Interventions
OTHERCollect 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.
Sponsors
University of Algiers
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | The patient will be assessed from the beginning of each pregnancy and in the three month after childbirth | * 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. |
Countries
Algeria
Contacts
Primary ContactWafia- Nadia Nibouche - Hattab, Professor in medicine
Outcome results
None listed