Clinical trial NCT05176041: SLE Therapy Changes in Pregnancy and Relation to Pregnancy Outcome
Official title: Therapeutic Alterations of Systemic Lupus Erythematosus (SLE) Patients in Pregnancy and Feto-maternal Outcomes; Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Growth Retardation
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 156
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with SLE

Brief summary: to review the changes to SLE medications during pregnancy including adherence and non-adherence to the medications and correlate these to the pregnancy outcome and post-partum course of the disease.

Detailed description: This was a retrospective study of pregnancies in SLE patients. These patients had confirmed SLE diagnosis according to the American College of Rheumatology (ACR) criteria (5). The diagnosis of SLE was confirmed by consultant rheumatologist. These patients were followed up by consultant rheumatologist and obstetrician. The pregnancies' data were curated using the patients' medical files and notes, both paper-based and electronic, antenatal records, rheumatology and hematology clinic notes in addition to delivery and postpartum records. These data were collected including ID numbers, ages, duration of the SLE, their SLE medications before the pregnancy (names, doses and frequency) and whether the SLE was active or not in the 6 months prior to the pregnancy using systemic lupus erythematosus disease activity index (SLEDAI) score. the investigators studied Hydroxychloroquine (HCQ), prednisolone and anti-coagulants (low-dose acetylsalicylic acid; 100 mg orally once daily and low molecular weight heparins (LMWH) Enoxaparin 40 mg subcutaneously once daily) as these were the most commonly used medications. The use of these medications in the different pregnancy periods were noted and analyzed (BPG, before pregnancy; DPG, during pregnancy; PG, pregnancy; PP, post-partum). Changes in these medications were also recorded. The data was then analyzed to find out the rates of changes and discontinuation. The postpartum period was also studied similarly. The investigators correlated these alterations to the following feto-maternal outcomes; miscarriage, preterm delivery, intra-uterine growth restriction (IUGR) and intra-uterine fetal death (IUFD). The 6 months-pre-conceptual SLEDAI score was recorded and investigated in relation to the above mentioned feto-maternal outcomes and postpartum relapse. We divided the pregnancies into 2 groups; Group A, inactive SLE and SLEDAI score of 0-3; Group b, active SLE and SLEDAI score of 4-24.

Eligibility criteria: Inclusion Criteria:

* confirmed SLE
* completed data

Exclusion Criteria:

* doubtful diagnosis of SLE
* those with missing data
* those with medications other than prednisolone, HCQ and anticoagulants
* those with multifetal pregnancies
* those patients with confirmed other medical diseases including diabetes mellitus, hypertension, thyroid disorders, anti-phospholipid antibody syndrome (APAS), cardiac disease
* those with confirmed deep vein thrombosis (DVT) or pulmonary embolism (PE)
* those with associated hematological diseases including SLE-associated thrombocytopenia.

Primary outcomes:
measure: fetal growth restriction
timeFrame: 8 months
measure: development of pre-eclampsia
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The University of Jordan
name: Naser Al-Husban, A. Professor
role: PRINCIPAL_INVESTIGATOR
References: