Fetal Myelomeningocele Repair With Maternal BMI Between 3... | NCT02509377

Studies
Fetal Myelomeningocele Repair With Maternal BMI Between 35.0 and 40.0

NCT02509377

Sponsor

St. Louis University

Status

Terminated

Last Update Posted

Jun 28, 2018Actual

Enrollment

1Actual

Phase

Not Applicable

Conditions

Myelomeningocele
Pregnancy

Interventions

Open Fetal Repair of Myelomeningocele

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

May 2017Actual

Completion Date

May 2017Actual

First Submitted Date

Jul 23, 2015

First Submission Date that Met QC Criteria

Jul 24, 2015

First Posted Date

Jul 28, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2018

Last Update Posted Date

Jun 28, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BMI 35.0 to 40.0	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Open Fetal Repair of Myelomeningocele	Procedure	Open Fetal Repair of Myelomeningocele when mothers BMI is elevated	BMI 35.0 to 40.0

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	up to 40 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Emanuel Vlastos, Associate Professor	St. Louis University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
SSM Cardinal Glennon Fetal Care Institute		St Louis	Missouri	63104	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21306277	Result	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.

ID	Term
D008591	Meningomyelocele
D016135	Spinal Dysraphism

ID	Term
D009436	Neural Tube Defects
D009421	Nervous System Malformations
D009422	Nervous System Diseases
D000013	Congenital Abnormalities