NCT02934295

Brief Summary

The aim of the research is to study humoral and cellular immunity in pregnant women for who the level of rubella virus antibodies is weakly positive, equivocal or negative with the usual laboratory technique.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
192

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

2 active sites

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

February 1, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2016

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

2.2 years

First QC Date

October 13, 2016

Last Update Submit

January 31, 2017

Conditions

Pregnancy

Keywords

Rubeola

Outcome Measures

Primary Outcomes (1)

  • Level of Anti-Rubella Antibody, E1

    8 months

Study Arms (1)

Pregnant women

EXPERIMENTAL
Biological: Determination of Anti-Rubella Antibody, E1

Interventions

Determination of Anti-Rubella Antibody, E1BIOLOGICAL
Pregnant women

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women over 18
  • Rubella serology negative, ambiguous or weakly positive during a first prenatal consultation and for which the second determination of the immunity anti rubella is necessary after 18 weeks of pregnancy
  • Accepting the rubella vaccination after the childbirth;
  • Accepting a blood test, during a postnatal consultation, 6 in 8 weeks after vaccination, to verify their immunity towards the virus of the rubella.
  • Affiliated to a social security scheme
  • Having given a written consent

You may not qualify if:

  • Rubella contracted since the first serology realized during the first prenatal consultation
  • Autoimmune pathologies
  • Intolerance / allergy known about a previous vaccination whatever it is
  • Immunosuppression (HIV, transplants)
  • Injection of multivalent immunoglobulins (except anti-D)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Antoine-Béclère

Clamart, 92140, France

Location

Hôpital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Measles

Interventions

methyl N-acetylsibirosaminide

Condition Hierarchy (Ancestors)

Morbillivirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Olivier Picone

    Hôpital Foch

    PRINCIPAL INVESTIGATOR

  • Christelle VAULOUP-FELLOUS, MD

    Hôpital Brousse

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2016

First Posted

October 14, 2016

Study Start

February 1, 2012

Primary Completion

May 1, 2014

Study Completion

October 1, 2014

Last Updated

February 1, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)