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Fetal Myelomeningocele Repair With Maternal BMI Between 35.0 and 40.0 (MOMSto40BMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02509377
Recruitment Status : Terminated
First Posted : July 28, 2015
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
St. Louis University

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : July 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Co-morbidities in mothers having fetal MMC repair [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Exclusion Criteria:

  • History of maternal alloimmunization problem
  • Kell sensitization
  • Risk of preterm birth
  • History of spontaneous preterm birth
  • Cervix <20mm in length
  • Presence of cerclage
  • Placental problem
  • History of placental abruption
  • Placental Previa
  • Body-mass index of 40.1 or more
  • Maternal contraindication to surgery
  • Insulin-dependent pregestational diabetes
  • Hypertension or preeclampsia
  • HIV, hepatitis-B, or hepatitis-C positive
  • Other medical condition of risk to mother
  • Uterine problem
  • Previous hysterotomy in the active uterine segment
  • Severe fibroids
  • Uterine malformation (bicornuate, arcuate, unicornuate, didelphys)
  • No support person for periprocedural period
  • Inadequate support at home for pregnancy
  • Inadequate understanding of risks and benefits of fetal surgery
  • Inability to comply with medical restrictions, follow up after fetal surgery
  • Multiple gestation pregnancy (twins, triplets, etc.)
  • A fetal anomaly unrelated to myelomeningocele (heart defect, lung lesions)
  • Severe fetal kyphosis >30 degrees (curvature of the back)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02509377


Locations
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United States, Missouri
SSM Cardinal Glennon Fetal Care Institute
Saint Louis, Missouri, United States, 63104
Sponsors and Collaborators
St. Louis University
Investigators
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Principal Investigator: Emanuel Vlastos, Associate Professor St. Louis University
Publications of Results:
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Responsible Party: St. Louis University
ClinicalTrials.gov Identifier: NCT02509377    
Other Study ID Numbers: 24890
First Posted: July 28, 2015    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2017
Keywords provided by St. Louis University:
Fetal Surgery
Open Fetal Surgery
Elevated BMI
Body Mass Index
Spina Bifida
Additional relevant MeSH terms:
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Meningomyelocele
Spina Bifida Cystica
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities
Spinal Dysraphism