NCT03171103

Brief Summary

prospective analytical study of all pregnant ladies with systemic lupus in Beni-suef localities

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2017

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

3 years

First QC Date

May 25, 2017

Last Update Submit

May 27, 2017

Conditions

Systemic Lupus ErythematosusPregnancy Complications

Outcome Measures

Primary Outcomes (1)

  • maternal outcome

    Number of patients who have abortion,preterm labor,preeclampsia,eclampsia,accidental hemorrhage,oligohydramnios

    3 years

Secondary Outcomes (1)

  • fetal outcome

    3 years

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

All pregnant ladies in Beni-suef localities diagnosed as systemic lupus

You may qualify if:

  • all pregnant ladies with settled diagnosis of systemic lupus
  • all pregnant ladies who first diagnosed as systemic lupus during current pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Banī Suwayf, Egypt

Location

MeSH Terms

Conditions

Lupus Erythematosus, SystemicPregnancy Complications

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant lecturer

Study Record Dates

First Submitted

May 25, 2017

First Posted

May 31, 2017

Study Start

May 1, 2017

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

May 31, 2017

Record last verified: 2017-05

Locations

EG(1)