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

June 26, 2018 updated by: St. Louis University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63104
        • SSM Cardinal Glennon Fetal Care Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 40 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Louis University

Investigators

  • Principal Investigator: Emanuel Vlastos, Associate Professor, St. Louis University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (ACTUAL)

May 1, 2017

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

July 23, 2015

First Submitted That Met QC Criteria

July 24, 2015

First Posted (ESTIMATE)

July 28, 2015

Study Record Updates

Last Update Posted (ACTUAL)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 26, 2018

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24890

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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