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

Primary Purpose

Myelomeningocele, Pregnancy

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Open Fetal Repair of Myelomeningocele
Sponsored by
St. Louis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelomeningocele focused on measuring Fetal Surgery, Open Fetal Surgery, Elevated BMI, Body Mass Index, Spina Bifida

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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.

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)

Sites / Locations

  • SSM Cardinal Glennon Fetal Care Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BMI 35.0 to 40.0

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 23, 2015
Last Updated
June 26, 2018
Sponsor
St. Louis University
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1. Study Identification

Unique Protocol Identification Number
NCT02509377
Brief Title
Fetal Myelomeningocele Repair With Maternal BMI Between 35.0 and 40.0
Acronym
MOMSto40BMI
Official Title
Fetal Myelomeningocele Repair With Maternal BMI Between 35.0 and 40.0
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Study Start Date
July 2015 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Louis University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelomeningocele, Pregnancy
Keywords
Fetal Surgery, Open Fetal Surgery, Elevated BMI, Body Mass Index, Spina Bifida

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMI 35.0 to 40.0
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Open Fetal Repair of Myelomeningocele
Intervention Description
Open Fetal Repair of Myelomeningocele when mothers BMI is elevated
Primary Outcome Measure Information:
Title
Co-morbidities in mothers having fetal MMC repair
Description
Measure the co-morbidity of mothers with a BMI of 35.0 to 40.0. Compare to published data in the MOMS trial.
Time Frame
up to 40 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emanuel Vlastos, Associate Professor
Organizational Affiliation
St. Louis University
Official's Role
Principal Investigator
Facility Information:
Facility Name
SSM Cardinal Glennon Fetal Care Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21306277
Citation
Adzick NS, Thom EA, Spong CY, Brock JW 3rd, Burrows PK, Johnson MP, Howell LJ, Farrell JA, Dabrowiak ME, Sutton LN, Gupta N, Tulipan NB, D'Alton ME, Farmer DL; MOMS Investigators. A randomized trial of prenatal versus postnatal repair of myelomeningocele. N Engl J Med. 2011 Mar 17;364(11):993-1004. doi: 10.1056/NEJMoa1014379. Epub 2011 Feb 9.
Results Reference
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Fetal Myelomeningocele Repair With Maternal BMI Between 35.0 and 40.0

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