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Fetoscopic Meningomyelocele Repair Study (fMMC)

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ClinicalTrials.gov Identifier: NCT02230072
Recruitment Status : Recruiting
First Posted : September 3, 2014
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Belfort, Baylor College of Medicine

Brief Summary:

The purpose of the study is to evaluate the maternal and fetal outcomes of a new technique for the fetoscopic repair of fetal MMC at Texas Children's Hospital Pavilion for Women.

The investigators hypothesis is that this minimally invasive technique is feasible, and that this approach will have the same efficacy as open fetal surgery for MMC, but with significantly less maternal-fetal risk. Both mother and baby will benefit from the surgery. The fetus will have a repaired MMC defect, and the mother will not have a uterine incision (hysterotomy). A hysterotomy increases the risk of uterine rupture and requires that all subsequent deliveries are by cesarean section. There may also be a decreased risk of Pre-term Premature Rupture Of Membranes (PPROM) and prematurity when compared with the current open operation. Finally, a vaginal delivery is possible following the fetoscopic fetal surgery if the baby is shown to have a skin covered repair.


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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Minimally Invasive Fetal Neural Tube Defect Repair Study
Study Start Date : July 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2021


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.
Other Names:
  • Karl Storz, Tuttlingen, Germany
  • Richard Wolf Medical Instruments, Corp.
  • Karl Storz Endoscopy-America, Inc.
  • Cook Medical, Inc.
  • Lexion Medical, LLC.
  • Terumo Pinnacle




Primary Outcome Measures :
  1. Feasibility [ Time Frame: Time of procedure ]
    Whether the minimally invasive technique can be technically performed in human patients (success of primary skin closure) in a safe and effective manner.


Secondary Outcome Measures :
  1. Reversal of the Chiari II malformation with complete closure of the spinal defect. [ Time Frame: at birth ]
    Whether the minimally invasive technique results in an acceptable fetal outcome as defined by reversal of the Chiari II malformation, a reduced need for ventriculoperitoneal shunting or other procedures to avoid or treat hydrocephalus, and complete closure of the spinal defect with protection of the placode. In addition the procedure will be assessed as to whether it prevents loss of neurological level during intra-uterine life.



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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),
  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 CVS). If there is a balanced translocation with normal MCA with no other anomalies the candidate can be included. Patients declining invasive testing will be excluded.
  8. Family has considered and declined the option of termination of the pregnancy at less than 24 weeks,
  9. Family meets psychosocial criteria (sufficient social support, ability to understand requirements of the study), and
  10. Parental/guardian permission (informed consent) for follow up of 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 ≥35,
  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, and uterine anomalies,
  8. Maternal-fetal Rh isoimmunization, 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 patient's 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 6cm) 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 (e.g. 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, and
  15. Patient scores as severely depressed on the BDI-II questionnaire; a score of 29 or above.

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): NCT02230072


Contacts
Contact: Michael A. Belfort, M.D., Ph.D. 832-826-7375 belfort@bcm.edu
Contact: Wyoniquea D. Rahming, MBA 832-826-7345 rahming@bcm.edu

Locations
United States, California
Stanford University: Lucille Packard's Childrens 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      
Principal Investigator: Michael A Belfort, M.D.         
Sub-Investigator: William E. Whitehead, M.D.         
Sub-Investigator: Alireza A. Shamshirsaz, M.D.         
Sub-Investigator: Ahmed Nassr, M.D.         
Sub-Investigator: Duong D. Tu, M.D.         
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Michael A. Belfort, M.D. Baylor College of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Belfort, Professor and Chairman, Department of Obstetrics and Gynecology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02230072     History of Changes
Other Study ID Numbers: H-34680
First Posted: September 3, 2014    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018

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
Spina bifida
Neural Tube Defect

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