NCT00199628

Brief Summary

Problems of compatibility between a mother and her child are frequent. The most well-known case can be illustrated by the fetomaternal blood group incompatibility (rhesus factor) which can induce severe anemia of the fetus. The investigators recently proved that incompatibility between mother and child can concern an organ leading to a tissular alloimmunization. For example, neonatal membranous glomerulonephritis (a kidney disease) can result from this mechanism. The purpose of this network is to detect and study neonatal diseases induced by tissular fetomaternal alloimmunization. The detection of these diseases will be performed by the mother's serum analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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, 2005

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

January 15, 2019

Status Verified

September 1, 2005

Enrollment Period

7.9 years

First QC Date

September 14, 2005

Last Update Submit

January 11, 2019

Conditions

Glomerulonephritis, MembranousNeonatal Diseases and AbnormalitiesHemochromatosis

Keywords

fetomaternal tissular alloimmunizationMothers having a child suffering from:neonatal membranous glomerulonephritisunexplained neonatal tubular defectunexplained thrombotic microangiopathyneonatal hemochromatosis

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant woman
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

pregnant woman

You may qualify if:

  • Mothers having a child suffering from:
  • Neonatal membranous glomerulonephritis
  • Unexplained neonatal tubular defect
  • Unexplained thrombotic microangiopathy
  • Neonatal hemochromatosis

You may not qualify if:

  • Any cause explaining the child's disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Limoges University Hospital

Limoges, 87042, France

Location

MeSH Terms

Conditions

Glomerulonephritis, MembranousCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHemochromatosisNeonatal hemochromatosis

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System DiseasesMetal Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornIron OverloadIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Vincent Guigonis, MD

    Department of Pediatrics, Limoges University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 20, 2005

Study Start

September 1, 2005

Primary Completion

August 1, 2013

Study Completion

August 1, 2014

Last Updated

January 15, 2019

Record last verified: 2005-09

Locations

FR(1)