Pregnant WomanTransAcNCT05821764
Investigation of the Passage of Antiviral Antibodies From Mother to Child
An observational study of Pregnant Woman and Adult Patient, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Infections remain a major cause of neonatal morbidity and mortality worldwide. At birth, multiple microorganisms, to which they are particularly vulnerable given the immaturity and naïve nature of their immune system, may infect newborns. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnant Woman, Adult Patient
- What is being tested?
- Blood sample and data collection
- Type of treatment
- Vaccines
- How many people
- 4,050 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2023to 15 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women followed in the Gynecology-Obstetrics department for their pregnancy and/or at the time of their delivery
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Infections remain a major cause of neonatal morbidity and mortality worldwide. At birth, multiple microorganisms, to which they are particularly vulnerable given the immaturity and naïve nature of their immune system, may infect newborns. Passive immunity by transplacental transfer of maternal antibodies is therefore of major importance in the first weeks and months of life before their own vaccination or until this period of immunological vulnerability has passed. Some factors are known to affect transplacental passage of antibodies but these have generally been studied in small series and many other parameters have not yet been investigated. The transmission rate of antibodies, particularly neutralizing antibodies, remains little explored, as well as the difference in transfer between antibodies induced by vaccination and those induced by natural infection, or the influence of maternal factors such as multiple pregnancy, other infections and treatment of these infections. A better identification and understanding of the factors that can affect transplacental transfer of maternal antibodies is crucial for optimization of vaccination strategies and close monitoring of particularly vulnerable newborns.
Read the 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.
- Conditions
- Pregnant Woman, Adult Patient
- Being tested
- Blood sample and data collection
- Keywords
- Transfer, Placenta, Antibody, Virus
- Medical subject headings
- Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample and data collectionOther
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 :
- Maternal sample within 72 hours before or after delivery during a care-based venipuncture (additional 10 mL sample) ;
- The cord blood sample (10 mL) immediately after delivery.
Data collection :
- A data collection sheet for the attention of the investigator (doctor or midwife) ;
- Additional data relating to the history of vaccination and infection completed by the patients included during their stay in the maternity ward and before their discharge from the hospital (Delay between 0 and 6 days after inclusion).
| Study group | Role | What they receive |
|---|---|---|
| The cohort for the TransAc study | Pregnant women followed for their pregnancy in the 3 Gynecology-Obstetrics department participating in the study Receives: Other: Blood sample and data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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).
Measured: 15 months
Secondary outcomes (2)
Compare transplacental transmission ratios of the different specific antibodies.
Ratios will be expressed in absolute values : "antibody level in the newborn (units/ml) / antibody level in the mother (units/ml)
Measured: 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
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)
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start15 May 2023 (estimated)
- Primary completion15 May 2024 (estimated)
- Study completion15 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomanStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christelle VAULOUP FELLOUS, Doctor, Principal investigator, Paul Brousse Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821764
- Sponsor's protocol ID
- 2022-A01800-43
- Acronym
- TransAc
- Status last verified
- Apr 2023
- First submitted
- 7 Apr 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Passage of Antiviral Antibodies From Mother to Child
- ClinicalTrials.gov ID
- NCT05821764
- Acronym / sponsor ID
- TransAc / 2022-A01800-43
- Conditions
- Pregnant Woman, Adult Patient
- Keywords
- Transfer, Placenta, Antibody, Virus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,050 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 May 2023 (estimated)
- Primary completion
- 15 May 2024 (estimated)
- Study completion
- 15 Aug 2024 (estimated)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Infections remain a major cause of neonatal morbidity and mortality worldwide. At birth, multiple microorganisms, to which they are particularly vulnerable given the immaturity and naïve nature of their immune system, may infect newborns. Passive immunity by transplacental transfer of maternal antibodies is therefore of major importance in the first weeks and months of life before their own vaccination or until this period of immunological vulnerability has passed. Some factors are known to affect transplacental passage of antibodies but these have generally been studied in small series and many other parameters have not yet been investigated. The transmission rate of antibodies, particularly neutralizing antibodies, remains little explored, as well as the difference in transfer between antibodies induced by vaccination and those induced by natural infection, or the influence of maternal factors such as multiple pregnancy, other infections and treatment of these infections. A better identification and understanding of the factors that can affect transplacental transfer of maternal antibodies is crucial for optimization of vaccination strategies and close monitoring of particularly vulnerable newborns.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The cohort for the TransAc study | – | Other: Blood sample and data collectionPregnant women followed for their pregnancy in the 3 Gynecology-Obstetrics department participating in the study |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women followed in the Gynecology-Obstetrics department for their pregnancy and/or at the time of their delivery
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample and data collectionSolicitation 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 : * Maternal sample within 72 hours before or after delivery during a care-based venipuncture (additional 10 mL sample) ; * The cord blood sample (10 mL) immediately after delivery. Data collection : * A data collection sheet for the attention of the investigator (doctor or midwife) ; * Additional data relating to the history of vaccination and infection completed by the patients included during their stay in the maternity ward and before their discharge from the hospital (Delay between 0 and 6 days after inclusion). | Other | The cohort for the TransAc study |
Primary outcome
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).
2 secondary outcomes
Compare transplacental transmission ratios of the different specific antibodies.
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christelle VAULOUP FELLOUS, Doctor principal investigator
Paul Brousse Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant Woman and Adult Patient, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christelle VAULOUP FELLOUS, Doctor (+33 1.45.59.33.14, christelle.vauloup-fellous@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.