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Open Myelomeningocele Repair With High Maternal BMI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03044821
Recruitment Status : Terminated (We now offer the repair as standard of care up to BMI of 40.)
First Posted : February 7, 2017
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Belfort, Baylor College of Medicine

Brief Summary:

Spina bifida is a neurological abnormality characterized by an opening in the skin and exposure of the spinal cord on the back of the baby at the time of birth. The complete closure and separation of the spinal cord from the skin occurs in the first month of pregnancy.

This form of spina bifida is associated with leg weakness, sensation loss, and bowel and bladder incontinence. The majority of patients (>80%) also develop increased fluid in the brain, called hydrocephalus, and require additional surgery to treat this problem. Standard treatment of myelomeningocele (MMC) involves closing the opening in the back within the first 3 days of life. The surgery releases the spinal cord from the skin and brings the skin edges together to prevent infection and injury to the exposed nerves. Of note, this type of surgery does not improve function.

The investigators want to study the open in-utero fetal surgery technique in patients who are candidates for the standard open fetal repair technique but have a pre-pregnancy BMI of 35.0-40.0. The latter is a reason for exclusion for open fetal repair in most centers in the United States.


Condition or disease Intervention/treatment Phase
Neural Tube Defect Procedure: Open-Uterus Fetal Repair Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Fetal Myelomeningocele Repair With Maternal BMI Between 35.0 And 40.0
Actual Study Start Date : July 18, 2018
Actual Primary Completion Date : July 16, 2019
Actual Study Completion Date : July 16, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Open-Uterus Fetal Repair
Single arm study. All patients will receive the open-uterus fetal repair.
Procedure: Open-Uterus Fetal Repair
Single arm study. All patients will receive the open-uterus fetal repair.




Primary Outcome Measures :
  1. Complications associated with obesity during Surgery. [ Time Frame: At the time of fetal repair surgery. ]
    Determine if there is an increased risk for mothers with a BMI of 35-40 during an open in-utero surgical repair for myelomeningocele.

  2. Complications associated with obesity during pregnancy. [ Time Frame: During the post-surgical course of pregnancy. ]
    Determine if there is an increased risk for mothers with a BMI of 35-40 after having undergone an open in-utero surgical repair for myelomeningocele.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 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).
  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, uterine anomalies incompatible with fetoscopy.
  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 (ie. 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 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): NCT03044821


Locations
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United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Michael Belfort, MD, PhD 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: NCT03044821    
Other Study ID Numbers: H-38734
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Belfort, Baylor College of Medicine:
Neural Tube Defect
Additional relevant MeSH terms:
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Meningomyelocele
Spina Bifida Cystica
Neural Tube Defects
Spinal Dysraphism
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities