New study tracks RSV in pregnant women and their babies
NCT ID NCT05443607
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study follows 300 pregnant women who had respiratory infections to see if RSV can pass from mother to baby before birth. Researchers will test blood from mothers and umbilical cords for RSV antibodies and viruses. Babies will be tracked for up to 4 years to monitor respiratory health and growth.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could reveal how RSV is transmitted during pregnancy and inform future prevention strategies for newborns.
- What could go wrong
- This is an observational study, not a treatment trial. It cannot prove cause and effect, and results may not apply to all populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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300 people
The number who actually took part.
- Started
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May 2020
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Pregnant women who plan to deliver at Tulane Lakeside Hospital and Clinic and Ochsner Baptist Medical Center will be considered for inclusion in the study. Pregnant women and their infants who fulfill all inclusion criteria are eligible for participation.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 18 years or older; 2. 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 3. 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. 4. History negative for Human Immunodeficiency Virus (HIV) 5. No use of immunosuppressive medications/therapies. 6. Singleton gestation; 7. Willing to allow for follow up of the child via their medical record from the time of delivery to 4 years of age. 8. 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. 9. English or Spanish proficiency Exclusion Criteria: 1. Under 18 years of age at the time of consent. 2. Gestational age less than 12.0 weeks at the time of consent. 3. 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. 4. Positive medical history for HIV. 5. Current use of immunosuppressive therapies/drugs. 6. Newborn has been diagnosed with congenital abnormality or chronic disease at birth. 7. Unwilling or unable to provide written informed consent. 8. Mother was not pregnant during the RSV season or no positive SARS-CoV-2 test during pregnancy. 9. Subject is unwilling to allow for follow up of the child via medical records from the time of delivery to 4 years of age; 10. Multiple birth; 11. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Ochsner Baptist Hospital
New Orleans, Louisiana, 70115, United States
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Tulane University Lakeside Hospital
Metairie, Louisiana, 70001, United States
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