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Extended Criteria For Fetal Myelomeningocele Repair

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ClinicalTrials.gov Identifier: NCT02664207
Recruitment Status : Recruiting
First Posted : January 26, 2016
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
KuoJen Tsao, The University of Texas Health Science Center, Houston

Brief Summary:

The purpose of this study is to offer pre-natal Myelomeningocele (MMC) repair surgery to pregnant women with one of the former surgery exclusion factors

  • A BMI of 35-40 kg/m2
  • Diabetes; patients will require good glycemic control
  • History a previous preterm birth, as long as it was followed by a full term birth
  • Structural abnormality in the fetus; abnormality must be minor, not increasing the risk of prematurity. For example cleft lip and palate, minor ventricular septal defect, pyelectasis.
  • Maternal Rh alloimmunization. Must have a low level of anti-red blood cell antibody that is not associated with fetal disease, specifically anti-E < 1:4 or anti-M. Or alloimmunization with negative fetal red blood cell antigen status determined by amniocentesis.

We will be extending the Management of Myelomeningocele Study (MOMs) criteria by including these factors. Prenatal clinical and outcome information will be collected; safety and efficacy will be evaluated


Condition or disease Intervention/treatment Phase
Obesity Myelomeningocele Pregnancy Diabetes Mellitus in Pregnancy Fetal Anomaly Procedure: Open Fetal Repair of Myelomeningocele Not Applicable

Detailed Description:

The purpose of this study is to extend the MOMs requirements for pre-natal MMC repair surgery and evaluate safety and efficacy. This will be accomplished through prenatal and post-operative observation and data collection.

The data collected will be documented and collected from prenatal ultrasounds, operative, and delivery reports. We will share our preliminary data with NAFTNet in order to prompt a multicenter trial; this collaboration will help propagate further research and answer clinical questions regarding this extension in surgery criteria.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extended Criteria For Fetal Myelomeningocele Repair: A Pilot Study
Study Start Date : December 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fetal Surgery in Women with ex

Fetal myelomeningocele repair surgery will be offered to pregnant women meeting the criteria for surgery (as set by the MOMS trial) with the exception of the following:

  • a BMI greater than 35 (but less than or equal to 40 kg/m2)
  • (minor) Fetal structural abnormality
  • (well-controlled) Diabetes
  • Previous preterm delivery (followed by a full term delivery)
  • Maternal red cell alloimmunization (must NOT be associated with fetal disease, OR fetus must have negative red cell antigen status as determined by amniocentesis).

Intervention: Open Fetal Repair of Myelomeningocele

Procedure: Open Fetal Repair of Myelomeningocele
Fetal repair of myelomeningocele in women with additional medical factors that would have excluded them from this treatment under the MOMs trial inclusion/exclusion criteria




Primary Outcome Measures :
  1. Post-operative complications [ Time Frame: At the time of fetal repair surgery to 40 weeks gestation ]
    Determine if there is an increased risk in women in this group



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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any woman with a prenatal diagnoses of myelomeningocele.
  • Pre-pregnancy BMI of 35-40 kg/m2.
  • Diabetes; patients will require good glycemic control
  • History a previous preterm birth, as long as it was followed by a full term birth
  • Structural abnormality in the fetus; abnormality must be minor, not increasing the risk of prematurity. For example cleft lip and palate, minor ventricular septal defect, pyelectasis.
  • Maternal Rh alloimmunization. Must have a low level of anti-red blood cell antibody that is not associated with fetal disease, specifically anti-E < 1:4 or anti-M. Or alloimmunization with negative fetal red blood cell antigen status determined by amniocentesis.
  • same MOMs Trial inclusion criteria with the exception of the above.

Exclusion Criteria:

  • poor glycemic control (i.e., HbA1c ≥ 8%) in spite a medical antidiabetic therapy in accordance with good clinical practice (GCP)
  • presence of significant co-morbidities or complications (such as dyslipidemia, uncontrolled arterial hypertension, impaired renal function, neuropathy, retinopathy, CVD)
  • severe diabetes complications or associated medical conditions (such as blindness, endstage renal failure, liver cirrhosis, malignancy, chronic congestive heart failure)
  • recent (within preceding 12 months) myocardial infarction, stroke or TIA
  • unstable angina pectoris
  • same MOMs Trial exclusion criteria (with the exception of extended inclusion criteria)

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): NCT02664207


Contacts
Contact: Kuojen Tsao, MD 713-500-7327 KuoJen.Tsao@uth.tmc.edu
Contact: Yisel Morales, B.S. 713-486-6560 yisel.morales@uth.tmc.edu

Locations
United States, Texas
Children's Memorial Hermann Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Kuojen Tsao, MD    713-500-7327    KuoJen.Tsao@uth.tmc.edu   
Contact: Yisel Morales, B.S.    713-486-6560    yisel.morales@uth.tmc.edu   
The Fetal Center at UTHealth Recruiting
Houston, Texas, United States, 77030
Contact: Kuojen Tsao, MD    713-500-7327    KuoJen.Tsao@uth.tmc.edu   
Contact: Yisel Morales, B.S.    713-486-6560    yisel.morales@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Kuojen Tsao, MD The University of Texas Health Science Center at Houston - UTHealth.

Additional Information:
Publications:
Responsible Party: KuoJen Tsao, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02664207     History of Changes
Other Study ID Numbers: HSC-MS-15-0795
First Posted: January 26, 2016    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by KuoJen Tsao, The University of Texas Health Science Center, Houston:
Myelomeningocele repair
Open Neural Tube Defect
BMI of 35-40 kg/m2,
Open Fetal Surgery
Elevated body mass index

Additional relevant MeSH terms:
Meningomyelocele
Spina Bifida Cystica
Diabetes Mellitus
Congenital Abnormalities
Pregnancy in Diabetics
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Spinal Dysraphism
Pregnancy Complications