Pregnancies Before the Diagnosis of Systemic Lupus Erythematosus

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 55 years
• Women only
• No healthy volunteers
• Adult

Study 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 locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Pregnancy Outcomes Prior to a Systemic Lupus Erythematosus Diagnosis

Conditions

Pregnancy Complications, SLE

Being tested

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

Keywords

Pregnancy, SLE, Obstetrical events

Medical subject headings

Pregnancy Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.

   Measured: The patient will be assessed from the beginning of each pregnancy and in the three month after childbirth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted29 Aug 2025
2. Study start1 Jan 2025
3. Primary completion31 Dec 2025 (estimated)
4. Study completion30 Apr 2026 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.