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Completed

NCT Number: NCT05176041

SLE Therapy Changes in Pregnancy and Relation to Pregnancy Outcome

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Naser Al-Husban

Other

observation

Primary outcomes

  1. fetal growth restriction

    Time frame: 8 months

    the effects of changes in SLE medications in pregnancy periods on final new born weight in grams.

  2. development of pre-eclampsia

    Time frame: 6 months

    SLE medication change and its effects on risk of pre-eclampsia

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study title

Therapeutic Alterations of Systemic Lupus Erythematosus (SLE) Patients in Pregnancy and Feto-maternal Outcomes; Retrospective Cohort Study

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Jan 4, 2022
Registry last updated
Jan 4, 2022

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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