NCT05176041

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 4, 2022

Completed
Last Updated

January 4, 2022

Status Verified

December 1, 2021

Enrollment Period

4.2 years

First QC Date

December 5, 2021

Last Update Submit

December 28, 2021

Conditions

Fetal Growth Retardation

Outcome Measures

Primary Outcomes (2)

  • fetal growth restriction

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

    8 months

  • development of pre-eclampsia

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

    6 months

Interventions

Naser Al-HusbanOTHER

observation

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women with SLE

You may qualify if:

  • confirmed SLE
  • completed data

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Naser Al-Husban, A. Professor

    The University of Jordan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 5, 2021

First Posted

January 4, 2022

Study Start

September 1, 2016

Primary Completion

November 1, 2020

Study Completion

January 1, 2021

Last Updated

January 4, 2022

Record last verified: 2021-12