- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05821764
Investigation of the Passage of Antiviral Antibodies From Mother to Child (TransAc)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators aim to include 4050 patients and collect a maternal at delivery cord blood sample.
The aim of the investigators is to measure and compare ratio of transplacental transfer of maternal anti-virus antibodies according to the mode of acquisition of immunity (post-vaccination, or post-natural or mixed infection), gestational age at birth (< 32 Weeks of Gestation -WG-, 32-37 WG and > 37 WG) for several virus (Hepatitis B virus, Varicella zoster virus, Rubella virus, Measles, Influenza Virus, Mumps Virus, SARS-CoV-2, Cytomegalovirus, Herpes Simplex Virus 1 and 2, Respiratory Syncitial Virus, Parvovirus B19, HTLV). The investigators also aim to identify factors likely to influence negatively or positively transplacental transfer of maternal antibodies as maternal age, maternal ethnic origin, parity and gestation, sex of the newborn, maternal chronic or acute infection/disease occurring during pregnancy; Birth weight, vaccine boost carried out during pregnancy (etc.) will also be studied.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Christelle VAULOUP FELLOUS, Doctor
- Phone Number: +33 1.45.59.33.14
- Email: christelle.vauloup-fellous@aphp.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women over 18 years old ;
- Pregnant patient (single or multiple pregnancy) ;
- Gestational age at the time of inclusion > 22 Weeks of Gestation ;
- Patient affiliated or entitled to a french social security scheme ;
- Patient who expressed a non-objection to participate in the study.
Exclusion Criteria:
- Misunderstanding of the French language;
- Participation in another interventional trial of category 1. Participation in category 2 research, with minimal risks and constraints, will be left to the discretion of the investigator;
- Patient under curatorship or guardianship ;
- Patient's refusal to participate in the research.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
The cohort for the TransAc study
Pregnant women followed for their pregnancy in the 3 Gynecology-Obstetrics department participating in the study
|
Solicitation of parturients during a prenatal visit between 22 and 41 weeks of gestation or during their hospitalization in a high-risk pregnancy sector and at the latest on the day of their delivery. Blood sample :
Data collection :
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure the transplacental transfer ratio of maternal anti-virus antibodies according to the mode of acquisition of immunity, gestational age at birth of specific viruses
Time Frame: 15 months
|
This is a descriptive study that aim to measure the ratio of transplacental transfer of maternal anti-virus antibodies according to the mode of acquisition of immunity (post-vaccination, or post-natural or mixed infection), gestational age at birth (< 32 WA, 32-37 WA and > 37 WA) for the following virus : Hepatitis B virus, Varicella zoster virus, Rubella virus, Measles, Influenza Virus, Mumps Virus, SARS-CoV-2, Cytomegalovirus, Herpes Simplex Virus 1 and 2, Respiratory Syncitial Virus, Parvovirus B19, HTLV. Ratios will be expressed in absolute values : "antibody level in the newborn (units/ml) / antibody level in the mother (units/ml). |
15 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare transplacental transmission ratios of the different specific antibodies.
Time Frame: 15 months
|
Ratios will be expressed in absolute values : "antibody level in the newborn (units/ml) / antibody level in the mother (units/ml)
|
15 months
|
Identify factors likely to influence transplacental transfer of the maternal antibodies as maternal age, ethnic origin, parity and gestation, sex of the child, maternal chronic or acute infection/disease occurring during pregnancy
Time Frame: 15 months
|
Identify factors likely to influence negatively or positively transplacental transfer of the maternal antibodies as maternal age, maternal ethnic origin, parity and gestation, sex of the newborn, maternal chronic or acute infection/disease occurring during pregnancy,birth weight, vaccine boost carried out during pregnancy. Ratios will be expressed in absolute values : "antibody level in the newborn (units/ml) / antibody level in the mother (units/ml) |
15 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Christelle VAULOUP FELLOUS, Doctor, Paul Brousse Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pregnant Woman
-
Universidad de GranadaUnknownPregnant Woman With Single Pregnancy | Pregnant Woman With no Assisted ReproductionSpain
-
Centre Hospitalier Universitaire de BesanconRecruiting
-
Centre Hospitalier Universitaire de BesanconCompletedPregnant WomanFrance
-
Assistance Publique - Hôpitaux de ParisCompletedPregnant Woman With Twins After 22 Weeks 0 Days of GestationFrance
-
National Defense Medical Center, TaiwanRecruitingBreastfeeding | Pregnant Woman | Maternal CompetenceTaiwan
-
University of ColomboWithdrawnPregnant Woman With Premature Rupture of Amnion MembranesSri Lanka
-
Claude Bernard UniversityElsan; University of NancyEnrolling by invitation
-
Sultan Abdulhamid Han Training and Research Hospital...CompletedPelvic Girdle Pain | Pregnant Woman | Biomechanical and Viscoelastic Properties of Plantar FasciaTurkey
-
Comenius UniversityRecruiting
-
Istanbul University - Cerrahpasa (IUC)Not yet recruiting
Clinical Trials on Blood sample and data collection
-
GlaxoSmithKlineCompletedMalariaSenegal, Burkina Faso
-
GlaxoSmithKlineCompleted
-
University Hospital, Basel, SwitzerlandKantonsspital St. Gallen, St. Gallen, SwitzerlandRecruitingLeptospirosis | Tularemia | Hepatitis E Virus InfectionSwitzerland
-
H. Lee Moffitt Cancer Center and Research InstituteActive, not recruitingPancreatic Cancer | Cancer CachexiaUnited States
-
GlaxoSmithKlineFoundation of Tropical Medicine; Goncalo Moniz research center; Evandro Chagas...Terminated
-
Institut PasteurJanssen Biotech, Inc.Recruiting
-
H. Lee Moffitt Cancer Center and Research InstituteNational Cancer Institute (NCI); University of Miami; University of FloridaRecruitingPancreatic Cancer | Pancreatic CystUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteUnited States Department of DefenseActive, not recruitingPancreatic CancerUnited States
-
GlaxoSmithKlineCompleted
-
GlaxoSmithKlineCompletedRespiratory DisordersUnited Kingdom