Extended Criteria for Fetal Myelomeningocele Repair

Investigators have extended the Management of Myelomeningocele Study (MOMs) inclusion criteria and are now offering Myelomeningocele (MMC) in utero surgical repair to pregnant women who are affected by one of the following 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.

Prenatal clinical and outcome information will be collected; safety and efficacy will be evaluated.

What is the purpose of this study?
The purpose of the study is to expand the requirements of in utero repair of Myelomeningocele (MMC), commonly known as spina bifida, to include women with other possible risk factors such as increased BMI, structural abnormality, diabetes etc.

Where is this study being conducted?
Currently The University of Texas Health Science Center at Houston is the only site in the United States taking part in this international clinical trial.

Who is the sponsor of the study?
Dr. KuoJen Tsao at The University of Texas Health Science Center Houston is the clinical trial sponsor.

Why should I participate in this study?
Your participation in the clinical trial may help investigators evaluate possible risks and benefits associated with fetal surgery in pregnant women affected by spina bifida and have other factors that would have otherwise precluded in-utero repair of spina bifida.

What happens to me if I participate in the study?
If you decide to take part in the study you will be undergo in utero repair of spina bifida. After the surgery you will be closely monitored and have weekly ultrasound exams for at least four weeks.

Is compensation available for participation?
At this time there is no compensation for participation in the study.

Who can I contact for more information about this study?
Please contact The Fetal Center at (832)325-7288 and ask to speak with a Fetal Center nurse coordinator or Senior Research Scientist, Jeannine Garnett.