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Patch vs. No Patch Fetoscopic Meningomyelocele Repair Study

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ClinicalTrials.gov Identifier: NCT03794011
Recruitment Status : Recruiting
First Posted : January 4, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Belfort, Baylor College of Medicine

Brief Summary:

The purpose of the study is to compare the maternal, fetal and neonatal outcomes of a cohort of 60 patients in whom a multilayer closure with a Durepair patch is performed with a prior cohort of patients in whom a standardized repair without patch (n = 32) was performed using the same minimally invasive fetoscopic repair technique.

The hypothesis is that there will be a thicker repair (as measured by MRI at 6 weeks post surgery) and less MMC repair dehiscence and/or CSF leak with the patch repair.


Condition or disease Intervention/treatment Phase
Neural Tube Defects Device: fetoscopy Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study to Compare 2 Minimally Invasive Fetal Neural Tube Defect Repair Techniques: Repair Using Durepair Patch vs. Repair Without Durepair Patch
Actual Study Start Date : December 18, 2018
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2025


Arm Intervention/treatment
Experimental: fetoscopic surgical repair
Single arm study. All patients will receive the fetoscopic repair.
Device: fetoscopy
The fetoscopic arm is described above. All patients will have a laparotomy, exteriorization of the uterus, and a fetoscopic repair of the fetal open neural tube defect including a the use of a Durepair patch.
Other Names:
  • Richard Wolf Medical Instruments, Corp.
  • Karl Storz Endoscopy-America, Inc.
  • Cook Medical, Inc.
  • Lexion Medical, LLC.
  • Terumo Pinnacle
  • Pare Surgical, Inc.
  • Medtronic Neurosurgery




Primary Outcome Measures :
  1. MMC Repair Dehiscence and/or CSF leak [ Time Frame: at birth ]
    Rate of MMC repair dehiscence and/or CSF leak in each group



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pregnant women - maternal age 18 years or older and capable of consenting for their own participation in this study.
  2. Singleton pregnancy.
  3. MMC with the upper boundary located between T1 and S1.
  4. Evidence of hindbrain herniation (confirmed on MRI to have an Arnold-Chiari type II malformation). An exception will be made for patients unable to have an MRI due to implants or any medical reasons. These patients will have the Arnold-Chiari type II malformation reviewed by ultrasonography.
  5. Absence of chromosomal abnormalities and associated anomalies
  6. Gestational age at the time of the procedure will be between 19 0/7 weeks and 25 6/7 weeks.
  7. Normal karyotype and/or normal chromosomal microarray (CMA) by invasive testing (amniocentesis or Chorionic Villus Sampling (CVS)). If there is a balanced translocation with normal CMA with no other anomalies the candidate can be included. Patients declining invasive testing will be excluded.
  8. The family has considered and declined the option of termination of the pregnancy at less than 24 weeks.
  9. The family meets psychosocial criteria (sufficient social support, ability to understand the requirements of the study).
  10. Parental/guardian permission (informed consent) for follow up of the child after birth.

Exclusion Criteria:

  1. Fetal anomaly unrelated to MMC.
  2. Severe kyphosis.
  3. Increased risk for preterm labor including short cervical length (<1.5 cm), history of incompetent cervix with or without cerclage, and previous preterm birth.
  4. Placental abnormalities (previa, abruption, accreta) known at time of enrollment.
  5. A pre-pregnancy body-mass index ≥40.
  6. Contraindications to surgery including previous hysterotomy (whether from a previous classical cesarean, uterine anomaly such as an arcuate or bicornuate uterus, major myomectomy resection, or previous fetal surgery) in active uterine segment.
  7. Technical limitations precluding fetoscopic surgery, such as uterine fibroids, fetal membrane separation, or uterine anomalies.
  8. Maternal-fetal Rh alloimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy.
  9. Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patients HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment.
  10. Maternal medical condition that is a contraindication to surgery or anesthesia.
  11. Low amniotic fluid volume (Amniotic Fluid Index less than 6 cm) if deemed to be due to fetal anomaly, poor placental perfusion or function, or membrane rupture. Low amniotic fluid volume that responds to maternal hydration is not an exclusion criterion.
  12. Patient does not have a support person (i.e. Spouse, partner, mother) available to support the patient for the duration of the pregnancy.
  13. Inability to comply with the travel and follow-up requirements of the trial.
  14. Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy.
  15. Patient scores as severely depressed on the Edinburgh Postnatal Depression Scale
  16. Maternal hypersensitivity to collagen.
  17. Umbilical Cord hypercoiling or velamentous cord insertion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794011


Contacts
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Contact: Michael A. Belfort, M.D., Ph.D. 832-826-7375 belfort@bcm.edu
Contact: Rebecca M Johnson, BA 832-826-7451 rj2@bcm.edu

Locations
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United States, California
Stanford University: Lucille Packard's Children's Hospital Recruiting
Stanford, California, United States, 94305
Contact: Yair Blumenfeld, MD    650-269-4665    yairb@stanford.edu   
Contact: Anna Girsen, PhD    650-725-0499    agirsen@stanford.edu   
Sub-Investigator: Yasser Y. El-Sayed, MD         
Sub-Investigator: Gerald Grant, MD         
Sub-Investigator: Karl G Sylvester, MD, FACS, FAAP         
Sub-Investigator: Susan Hintz, MD, MS         
United States, Texas
Texas Childrens Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Michael Belfort, M.D.    832-826-7375      
Contact: Rebecca Johnson, BA    832-826-7451      
Principal Investigator: Michael A Belfort, M.D.         
Sub-Investigator: William E Whitehead, M.D.         
Sub-Investigator: Alireza A Shamshirsaz, M.D.         
Sub-Investigator: Jimmy Espinoza, M.D.         
Sub-Investigator: Jonathan C Porter, M.D.         
Sub-Investigator: Duong D Tu, M.D.         
Sub-Investigator: Magdalena Sanz Cortes, M.D., PhD         
Sub-Investigator: Ahmed Nassr, M.D.         
Sub-Investigator: Howard Weiner, M.D.         
Sub-Investigator: Roopali Donepudi, M.D.         
Sub-Investigator: Mario Patino Velez, M.D.         
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Michael A. Belfort, M.D., Ph.D. Baylor College of Medicine

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Responsible Party: Michael Belfort, Professor and Chairman, Department of Obstetrics and Gynecology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03794011     History of Changes
Other Study ID Numbers: H-43359
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Michael Belfort, Baylor College of Medicine:
myelomeningocele
MMC
NTD
neural
defect
Spinal Bifida
Neural Tube Defect

Additional relevant MeSH terms:
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Neural Tube Defects
Spinal Dysraphism
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities