Clinical Trial: Extended Criteria For Fetal Myelomeningocele Repair

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Extended Criteria For Fetal Myelomeningocele Repair: A Pilot Study

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


Detailed Summary:

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.


Sponsor: The University of Texas Health Science Center, Houston

Current Primary Outcome: 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


Original Primary Outcome: Complications associated with Obesity in Pregnancy and Surgery [ Time Frame: At the time of fetal repair surgery to 40 weeks gestation ]

Determine if there is an increased risk in mothers with a BMI of 35-40 who've undergone open fetal repair for myelomeningocele.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: The University of Texas Health Science Center, Houston

Dates:
Date Received: January 19, 2016
Date Started: December 2015
Date Completion: January 2025
Last Updated: May 2, 2017
Last Verified: May 2017