Falls Church, VANCT03298334Now EnrollingIRB Ready

Cesarean Delivery Affecting Newborn Clinical Trial in Falls Church, VA

Access cutting-edge cesarean delivery affecting newborn treatment through this clinical trial at a research site in Falls Church. Study-provided care at no cost to qualified participants.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

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Expert Care in Falls Church

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related cesarean delivery affecting newborn treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Falls Church

    Convenient for VA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Falls Church site if eligible
  4. 4Begin participation

About This Cesarean Delivery Affecting Newborn Study in Falls Church

Neonates delivered by scheduled Cesarean Section will be randomized to receive vaginal seeding (exposing the infant to Mother's vaginal flora) or sham. Infants will be followed for three years to examine health outcomes including microbiome development, immune development, metabolic outcomes, and any adverse events.

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Who Can Participate

Inclusion Criteria

for Mother:
Scheduled for cesarean delivery at ≥ 37 weeks
Pregnant with single fetus, in good general health, age 18 years or older
Negative maternal testing for infections transmitted through vaginal and/or other body fluids performed as standard of care tests in early pregnancy
Negative testing for Group B strep at 35-37 weeks gestation
Vaginal pH ≤ 4.5 indicative of Lactobacillus-dominated vaginal microbiota
No maternal or fetal complications that may inhibit the ability to perform microbiome restoration per protocol
English or Spanish speaking
Negative maternal testing for Gonorrhea, Chlamydia, Hepatitis B, Hepatitis C, Syphilis, and HIV at 35 weeks gestation or later
Women aged 18-29 years must have a normal Pap test within 3 years
Women aged 30-65 years must have a normal Pap test and an HPV test (co-testing) within 5 years or FDA-approved primary hrHPV testing alone within 5 years or a normal Pap test alone within 3 years
Negative maternal testing for SARS-CoV-2 for the delivery admission performed as standard of care test at the Inova Health System. Inclusion Criteria for Infant:
Infant condition after delivery requires no more than standard neonatal resuscitation\
or is otherwise medically unable to receive the full VMT procedure \[\*\] Standard neonatal resuscitation may include: tactile stimulation, bulb suction, oxygen without positive pressure, or drying

Exclusion Criteria

for Mother:
Delivery at a hospital other than Inova Health System
Cesarean delivery scheduled for active infection that would have interfered with vaginal delivery such as genital herpetic lesions
Rupture of membranes prior to scheduled cesarean delivery
Bacterial vaginosis within 30 days of cesarean delivery
Symptomatic urinary tract infection within 30 days of cesarean delivery
Antibiotic therapy within 30 days of cesarean delivery (exclusive of medication use for prophylaxis at the time of surgery)
Symptoms on admission suggesting Chorioamnionitis, e.g. maternal fever, fundal tenderness
Symptoms on delivery admission of possible vaginal infection such as genital herpetic lesions
History of genital HSV
History positive testing for Group B strep infection
History of a child with a diagnosis of Group B strep sepsis
Pregnancy a result of donor egg or surrogacy
Preexisting history of Type I or Type II Diabetes
Maternal history of documented genital HPV infection, positive HPV testing or genital warts on physician examination
Positive maternal testing for SARS-CoV-2 within 30 days of delivery or symptoms on admission suggesting potential Covid-19 infection

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Falls Church?

Yes, this clinical trial (NCT03298334) has an active research site in Falls Church, VA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Cesarean Delivery Affecting Newborn Treatment Options in Falls Church, VA

If you're searching for cesarean delivery affecting newborn treatment options in Falls Church, VA, this clinical trial (NCT03298334) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Falls Church research site is actively enrolling participants for this clinical trial. You'll receive care from experienced cesarean delivery affecting newborn specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all cesarean delivery affecting newborn clinical trials near you to find additional studies recruiting in your area.

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