NCT02509377

Fetal Myelomeningocele Repair With Maternal BMI Between 35.0 and 40.0

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: St. Louis University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Inclusion and exclusion criteria for fetal repair of MMC was established by the Management of Myelomeningocele Study (MOMS Trial) and these criteria are the standard of care throughout the United States. These criteria state exclusion for hypertension and diabetes which are known co-morbidities for obesity. Investigators plan to expand one exclusion criteria for open fetal repair surgery. Currently, an exclusion factor is a maternal BMI of 35.0 and greater.Investigators will maintain all other inclusion and exclusion criteria (including excluding for hypertension and diabetes) with the exception of expanding the BMI to include mothers with a BMI of 35.0 to 40.0. Co-morbidities of the research group will be compared to the comorbidities of the mothers published in the MOMS trial.

Detailed description

The MOMS trial proved prenatal repair of myelomeningocele was an advantage over postnatal repair for the fetus/neonate/child and is the standard of care for maternal/fetal dyads who meet the inclusion exclusion criteria. Investigators plan to maintain all inclusion exclusion criteria for open fetal repair surgery of myelomeningocele with one exception, the expansion of the maternal BMI to 40.0. This population of mothers with a BMI of 35.0 to 40.0 have not been studied. The morbidities of these mothers will be compared to morbidities of mothers with a BMI less than or equal to 34.9 currently in the scientific literature.

Conditions

• Myelomeningocele
• Pregnancy

Interventions

Type	Name	Description
PROCEDURE	Open Fetal Repair of Myelomeningocele	Open Fetal Repair of Myelomeningocele when mothers BMI is elevated

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2015-07-28
• Last updated: 2018-06-28

Locations

1 site across 1 country: United States