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BMI 35.0 to 40.0 for Spina Bifida (MOMSto40BMI Trial)

N/A
Waitlist Available
Led By Emanuel Vlastos, Associate Professor
Research Sponsored by St. Louis University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 40 weeks
Awards & highlights

MOMSto40BMI Trial 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.

Eligible Conditions
  • Spina Bifida
  • Pregnancy

MOMSto40BMI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 40 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 40 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Co-morbidities in mothers having fetal MMC repair

MOMSto40BMI Trial Design

1Treatment groups
Experimental Treatment
Group I: BMI 35.0 to 40.0Experimental Treatment1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Open Fetal Repair of Myelomeningocele
2016
N/A
~20

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Who is running the clinical trial?

St. Louis UniversityLead Sponsor
194 Previous Clinical Trials
43,654 Total Patients Enrolled
Emanuel Vlastos, Associate ProfessorPrincipal InvestigatorSt. Louis University
~0 spots leftby Jun 2025