Extended Criteria For Fetal Myelomeningocele Repair

NCT02664207 | Completed DMC

• 1 other identifier: HSC-MS-15-0795
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to offer pre-natal Myelomeningocele (MMC) repair surgery to pregnant women with one of the former surgery exclusion factors

• A BMI of 35-40 kg/m2
• Diabetes; patients will require good glycemic control
• History a previous preterm birth, as long as it was followed by a full term birth
• Structural abnormality in the fetus; abnormality must be minor, not increasing the risk of prematurity. For example cleft lip and palate, minor ventricular septal defect, pyelectasis.
• Maternal Rh alloimmunization. Must have a low level of anti-red blood cell antibody that is not associated with fetal disease, specifically anti-E \< 1:4 or anti-M. Or alloimmunization with negative fetal red blood cell antigen status determined by amniocentesis. We will be extending the Management of Myelomeningocele Study (MOMs) criteria by including these factors. Prenatal clinical and outcome information will be collected; safety and efficacy will be evaluated

Conditions

Obesity; Myelomeningocele; Pregnancy; Diabetes Mellitus in Pregnancy; Fetal Anomaly

Keywords

Myelomeningocele repair; Open Neural Tube Defect; BMI of 35-40 kg/m2,; Open Fetal Surgery; Elevated body mass index

Outcome Measures

Primary Outcomes (1)

• Post-operative complications

  Determine if there is an increased risk in women in this group

  At the time of fetal repair surgery to 40 weeks gestation

Study Arms (1)

Fetal Surgery in Women with ex

EXPERIMENTAL

Fetal myelomeningocele repair surgery will be offered to pregnant women meeting the criteria for surgery (as set by the MOMS trial) with the exception of the following: * a BMI greater than 35 (but less than or equal to 40 kg/m2) * (minor) Fetal structural abnormality * (well-controlled) Diabetes * Previous preterm delivery (followed by a full term delivery) * Maternal red cell alloimmunization (must NOT be associated with fetal disease, OR fetus must have negative red cell antigen status as determined by amniocentesis). Intervention: Open Fetal Repair of Myelomeningocele

Procedure: Open Fetal Repair of Myelomeningocele

Interventions

Open Fetal Repair of Myelomeningocele PROCEDURE

Fetal repair of myelomeningocele in women with additional medical factors that would have excluded them from this treatment under the MOMs trial inclusion/exclusion criteria

Fetal Surgery in Women with ex

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Any woman with a prenatal diagnoses of myelomeningocele.
• Pre-pregnancy BMI of 35-45 kg/m2.
• Diabetes; patients will require good glycemic control
• History a previous preterm birth, as long as it was followed by a full term birth
• Structural abnormality in the fetus; abnormality must be minor, not increasing the risk of prematurity. For example cleft lip and palate, minor ventricular septal defect, pyelectasis.
• Maternal Rh alloimmunization. Must have a low level of anti-red blood cell antibody that is not associated with fetal disease, specifically anti-E \< 1:4 or anti-M. Or alloimmunization with negative fetal red blood cell antigen status determined by amniocentesis.

You may not qualify if:

• poor glycemic control (i.e., HbA1c ≥ 8%) in spite a medical antidiabetic therapy in accordance with good clinical practice (GCP)
• presence of significant co-morbidities or complications (such as dyslipidemia, uncontrolled arterial hypertension, impaired renal function, neuropathy, retinopathy, CVD)
• severe diabetes complications or associated medical conditions (such as blindness, endstage renal failure, liver cirrhosis, malignancy, chronic congestive heart failure)
• recent (within preceding 12 months) myocardial infarction, stroke or TIA
• unstable angina pectoris

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (2)

Children's Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

The Fetal Center at UTHealth

Houston, Texas, 77030, 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: 21306277 BACKGROUND

Related Links

• The Fetal Center at Children's Memorial Hermann Hospital

MeSH Terms

Conditions

Obesity; Meningomyelocele; Diabetes, Gestational; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kuojen Tsao, MD

  The University of Texas Health Science Center at Houston - UTHealth.

  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: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: January 26, 2016
• Study Start: January 26, 2016
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

US (2)