NCT02509377

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 28, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

June 28, 2018

Status Verified

June 1, 2017

Enrollment Period

1.8 years

First QC Date

July 23, 2015

Last Update Submit

June 26, 2018

Conditions

MyelomeningocelePregnancy

Keywords

Fetal SurgeryOpen Fetal SurgeryElevated BMIBody Mass IndexSpina Bifida

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Open Fetal Repair of MyelomeningocelePROCEDURE

Open Fetal Repair of Myelomeningocele when mothers BMI is elevated

BMI 35.0 to 40.0

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SSM Cardinal Glennon Fetal Care Institute

St Louis, Missouri, 63104, United States

Location

Related Publications (1)

  • 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.

    PMID: 21306277RESULT

MeSH Terms

Conditions

MeningomyeloceleSpinal Dysraphism

Condition Hierarchy (Ancestors)

Neural Tube DefectsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Emanuel Vlastos, Associate Professor

    St. Louis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2015

First Posted

July 28, 2015

Study Start

July 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

June 28, 2018

Record last verified: 2017-06

Locations

US(1)