NCT05443607Active, not recruiting
Transplacental Transmission of RSV (TTRSV)
A Prospective Cohort Study Evaluating the Transplacental Transmission of Respiratory Syncytial Virus (RSV) in Pregnant Women and Their Offspring
Source: ClinicalTrials.gov · Last updated 20 May 2026
Brief summary (registry, in English)
Aim 1: To study transplacental transmission of Respiratory Syncytial Virus (RSV) and how this is moderated by other maternal infections during pregnancy Aim 2: To test maternal blood for presence of RSV-specific immunoglobulins and how this is moderated by other maternal infections during pregnancy Aim 3: To test cord blood (fetal blood) for presence of RSV-specific immunoglobulins and other common viral pathogens Aim 4: To perform further tests (Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR), Droplet Digital Polymerase Chain Reaction (ddPCR) and immunoprobing) to confirm the presence of RSV and other common viral pathogens Aim 5: To follow these newborn infants up to 4 years of age to look for redisposition to respiratory diseases and growth parameters
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 300 (actual)
- First submitted
- 29 Jun 2022
- Start date
- May 2020
- Primary completion date
- Aug 2027
- Lead sponsor
- Tulane University
- Diseases
- Asthma
- NCT number
- NCT05443607
What you commit to
- Study type: Observational
- Participants enrolled: 300
- From May 2020 to the primary completion date, Aug 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of immunosuppressive therapies/drugs.
Other illness
- Does not report at least 2 of the following signs and symptoms of respiratory infection during pregnancy, including but not limited to: fever, nasal congestion/discharge, cough, and sore throat.
- Positive medical history for HIV.
- Newborn has been diagnosed with congenital abnormality or chronic disease at birth.
Age
- Under 18 years of age at the time of consent.
- Gestational age less than 12.0 weeks at the time of consent.
- Subject is unwilling to allow for follow up of the child via medical records from the time of delivery to 4 years of age;
Other
- Unwilling or unable to provide written informed consent.
- Mother was not pregnant during the RSV season or no positive SARS-CoV-2 test during pregnancy.
- Multiple birth;
- Lacks English or Spanish proficiency
- Infants will be excluded from the study in the event of a Serious Adverse Event such as fetal or acute neonatal death (in the delivery room) if the mother does not provide clinical consent for an autopsy.
Who the study is looking for
- Aged 18 years or older;
- Reported 2 or more signs and symptoms of respiratory infection during pregnancy, including but not limited to: fever, nasal congestion/discharge, cough, and sore throat and/or a positive SARS-CoV-2 test
- Deliveries at full term or near term (minimum 34 weeks gestation) in Labor and Delivery (L\&D) facilities at Tulane Lakeside Hospital and Clinic or Ochsner Baptist Medical Center who were pregnant during RSV season.
- History negative for Human Immunodeficiency Virus (HIV)
- No use of immunosuppressive medications/therapies.
- Singleton gestation;
- Willing to allow for follow up of the child via their medical record from the time of delivery to 4 years of age.
- Clearly understands the study procedures and visit schedule, alternative treatments, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
- English or Spanish proficiency
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tulane University Lakeside Hospital Coordinator of this site? Confirm its status | Metairie | United States | Unknown status |
| Ochsner Baptist Hospital Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.