MOMSto40BMI: Fetal Myelomeningocele Repair With Maternal BMI Between 35.0 and 40.0

Sponsor

St. Louis University (Other)

Overall Status

Terminated

CT.gov ID

NCT02509377

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Myelomeningocele Pregnancy	Procedure: Open Fetal Repair of Myelomeningocele	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Fetal Myelomeningocele Repair With Maternal BMI Between 35.0 and 40.0

Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

May 1, 2017

Actual Study Completion Date :

May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BMI 35.0 to 40.0 Mothers who meet all inclusion exclusion criteria for open fetal repair of myelomeningocele except BMI. These mothers have a BMI between 35.0 and 40.0	Procedure: Open Fetal Repair of Myelomeningocele Open Fetal Repair of Myelomeningocele when mothers BMI is elevated

Arm

Intervention/Treatment

Experimental: BMI 35.0 to 40.0

Mothers who meet all inclusion exclusion criteria for open fetal repair of myelomeningocele except BMI. These mothers have a BMI between 35.0 and 40.0

Procedure: Open Fetal Repair of Myelomeningocele

Open Fetal Repair of Myelomeningocele when mothers BMI is elevated

Outcome Measures

Primary Outcome Measures

Co-morbidities in mothers having fetal MMC repair [up to 40 weeks]
Measure the co-morbidity of mothers with a BMI of 35.0 to 40.0. Compare to published data in the MOMS trial.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Maternal BMI 35.0 to 40.0
No maternal documented co-morbidities
Fetal MMC begins between thoracic 1 and sacral 1, on the spinal column.
Evidence of fetal hindbrain herniation (hindbrain is being pulled down the spinal column).
A gestational age is between 19 weeks 0 days and 26 weeks with evidence of placental membrane fusion.
Documented normal fetal karyotype.