Extended Criteria For Fetal Myelomeningocele Repair

Last updated: May 6, 2024
Sponsor: The University of Texas Health Science Center, Houston
Overall Status: Completed

Phase

N/A

Condition

Birth Defects

Diabetes Prevention

Obesity

Treatment

Open Fetal Repair of Myelomeningocele

Clinical Study ID

NCT02664207
HSC-MS-15-0795
  • Ages 16-45
  • Female

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Any woman with a prenatal diagnoses of myelomeningocele.
  • Pre-pregnancy BMI of 35-45 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 therisk of prematurity. For example cleft lip and palate, minor ventricular septaldefect, pyelectasis.
  • Maternal Rh alloimmunization. Must have a low level of anti-red blood cell antibodythat is not associated with fetal disease, specifically anti-E < 1:4 or anti-M. Oralloimmunization with negative fetal red blood cell antigen status determined byamniocentesis.
  • same MOMs Trial inclusion criteria with the exception of the above.

Exclusion

Exclusion Criteria:

  • poor glycemic control (i.e., HbA1c ≥ 8%) in spite a medical antidiabetic therapy inaccordance 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)

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: Open Fetal Repair of Myelomeningocele
Phase:
Study Start date:
January 26, 2016
Estimated Completion Date:
December 31, 2023

Study 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.

Connect with a study center

  • Children's Memorial Hermann Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • The Fetal Center at UTHealth

    Houston, Texas 77030
    United States

    Site Not Available

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