Extended Criteria For Fetal Myelomeningocele Repair

  • STATUS
    Recruiting
  • End date
    Jan 26, 2028
  • participants needed
    40
  • sponsor
    The University of Texas Health Science Center, Houston
Updated on 26 May 2022
diabetes
premature birth
prematurity
prenatal
repair of myelomeningocele
cleft lip
amniocentesis

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

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.

Details
Condition Obesity, Myelomeningocele, Pregnancy, Diabetes Mellitus in Pregnancy, Fetal Anomaly
Treatment Open Fetal Repair of Myelomeningocele
Clinical Study IdentifierNCT02664207
SponsorThe University of Texas Health Science Center, Houston
Last Modified on26 May 2022

Eligibility

Yes No Not Sure

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 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)
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