Pregnancies Before the Diagnosis of Systemic Lupus Erythematosus

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.

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Key information

Conditions

Pregnancy Complications Female Urogenital Diseases and Pregnancy Complications SLE Urogenital Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of internal medicine, Ain-Taya's teaching Public hospital, Aïn Taya, Algiers Province, Algeria

About this study

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:

Are systemic signs of SLE present before or during pregnancy?
What were the fetal and maternal outcomes after or during each pregnancy? What is/was the severity of SLE after diagnosis?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

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.

Primary outcomes

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
- 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Wafia- Nadia Nibouche - Hattab, Professor in medicine

CONTACT

[email protected]

+213-771-810-932

Sponsors and collaborators

Lead sponsor

University of Algiers

Other

Registry information

Official study title

Pregnancy Outcomes Prior to a Systemic Lupus Erythematosus Diagnosis

Acronym: PREDILUP

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Aug 29, 2025
Registry last updated: Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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