Wellington, FLNCT03856034Now EnrollingIRB Ready

Neural Tube Defects Clinical Trial in Wellington, FL

Access cutting-edge neural tube defects treatment through this clinical trial at a research site in Wellington. Study-provided care at no cost to qualified participants.

Sponsored by USFetus

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Expert Care in Wellington

Access neural tube defects specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related neural tube defects treatment provided free

Apply for This Wellington Location

Check if you qualify for this neural tube defects clinical trial in Wellington, FL

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Wellington

    Convenient for FL 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 Wellington site if eligible
  4. 4Begin participation

About This Neural Tube Defects Study in Wellington

The purpose of this study is to evaluate the feasibility of a fetoscopic surgical technique for antenatal correction of fetal myelomeningocele. Two surgical approaches will be utilized. The percutaneous approach will be offered to participants with a posterior placenta. The laparotomy/uterine exteriorization approach will be offered to participants regardless of placental location.

Sponsor: USFetus

Who Can Participate

Inclusion Criteria

Myelomeningocele (including myeloschisis) at level T1 through S1 with hindbrain herniation. Lesion level and hindbrain herniation will be confirmed by MRI and ultrasonography.
Maternal age ≥18 years.
Gestational age of 19 to 27 6/7 weeks' gestation as determined by clinical information and evaluation of first ultrasound.
Balanced karyotype with written confirmation of culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is at 24 weeks or more.
Positive evaluation of social work consult indicating the patient is capable of consenting to the procedure and has the appropriate social support system to participate in the study.
Positive evaluation from pediatric neurology consult.
Willing to remain in the greater Wellington or Pasadena area (within a 30-minute car ride) for remainder of the pregnancy and deliver at Wellington Regional Medical Center or Huntington Memorial Hospital for postnatal management. The participants must be willing to return to our center for the 12, 24, 30, 48, and 60 months for follow-up evaluation.

Exclusion Criteria

Multiple gestation
Insulin-dependent pregestational diabetes
Presence of a fetal anomaly not related to myelomeningocele. A fetal echocardiogram will be conducted before surgery and if the finding is abnormal, the patient will be excluded.
Fetal kyphosis of 30 degrees or more, assessed by ultrasound or MRI.
Presence of uterine cervical cerclage or history of incompetent cervix.
Placenta previa or placental abruption.
Short cervix \< 25 mm measured by cervical ultrasound.
Obesity as defined by body mass index (BMI) of 35 or greater.
History of previous spontaneous singleton delivery prior to 37 weeks.
Maternal-fetal Rh isoimmunization, Kell sensitization or a history of neonatal alloimmune thrombocytopenia.
Maternal HIV or Hepatitis-B status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis B status is unknown, the patient must be tested and found to have negative results before she can be enrolled.
Known Hepatitis-C positivity. If the patient's Hepatitis C status is unknown, she does not need to be screened.
Uterine anomaly such as large (greater than 6 cm) fibroids, cervical fibroids or multiple fibroids or Mullerian duct abnormality.
Other maternal medical condition which is a contraindication to surgery or anesthesia.
Patient does not have a support person (e.g., husband, partner, parents).
Inability to comply with the travel and follow-up requirements of the study.
Patient does not meet psychosocial criteria as determined by the social worker evaluation.
Participation in another intervention study that influences maternal and fetal morbidity and mortality.
Maternal hypertension as determined by the investigator, which would increase the risk of preeclampsia or preterm delivery (including, but not limited to: uncontrolled hypertension, chronic hypertension with end organ damage and new onset hypertension in current pregnancy).
Bicornuate uterus or any other uterine malformation the PI decides is not safe for surgery.
Nickel allergy.
Maternal request to undergo open fetal surgery for the antenatal correction of open spina bifida at our institution primarily or after failed fetoscopic approach.
Known maternal hypersensitivity to bovine collagen or chondroitin materials.

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 Wellington?

Yes, this clinical trial (NCT03856034) has an active research site in Wellington, FL 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.

Neural Tube Defects Treatment Options in Wellington, FL

If you're searching for neural tube defects treatment options in Wellington, FL, this clinical trial (NCT03856034) 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 Wellington research site is actively enrolling participants for this clinical trial. You'll receive care from experienced neural tube defects 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 neural tube defects clinical trials near you to find additional studies recruiting in your area.

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Secure · Expert Care · Wellington, FL