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Extended Criteria For Fetal Myelomeningocele Repair

Primary Purpose

Obesity, Myelomeningocele, Pregnancy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Open Fetal Repair of Myelomeningocele
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Myelomeningocele repair, Open Neural Tube Defect, BMI of 35-40 kg/m2,, Open Fetal Surgery, Elevated body mass index

Eligibility Criteria

16 Years - 45 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.
  • same MOMs Trial inclusion criteria with the exception of the above.

Exclusion Criteria:

  • 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
  • same MOMs Trial exclusion criteria (with the exception of extended inclusion criteria)

Sites / Locations

  • Children's Memorial Hermann HospitalRecruiting
  • The Fetal Center at UTHealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fetal Surgery in Women with ex

Arm Description

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

Outcomes

Primary Outcome Measures

Post-operative complications
Determine if there is an increased risk in women in this group

Secondary Outcome Measures

Full Information

First Posted
January 19, 2016
Last Updated
May 17, 2022
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT02664207
Brief Title
Extended Criteria For Fetal Myelomeningocele Repair
Official Title
Extended Criteria For Fetal Myelomeningocele Repair: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 26, 2016 (undefined)
Primary Completion Date
January 2028 (Anticipated)
Study Completion Date
January 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
The purpose of this study is to extend the MOMs requirements for pre-natal MMC repair surgery and evaluate safety and efficacy. This will be accomplished through prenatal and post-operative observation and data collection. The data collected will be documented and collected from prenatal ultrasounds, operative, and delivery reports. We will share our preliminary data with NAFTNet in order to prompt a multicenter trial; this collaboration will help propagate further research and answer clinical questions regarding this extension in surgery criteria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Fetal Surgery in Women with ex
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Open Fetal Repair of Myelomeningocele
Intervention Description
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
Primary Outcome Measure Information:
Title
Post-operative complications
Description
Determine if there is an increased risk in women in this group
Time Frame
At the time of fetal repair surgery to 40 weeks gestation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. same MOMs Trial inclusion criteria with the exception of the above. Exclusion Criteria: 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 same MOMs Trial exclusion criteria (with the exception of extended inclusion criteria)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kuojen Tsao, MD
Phone
713-500-7327
Email
KuoJen.Tsao@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jeannine Garnett, PhD
Phone
(713) 486-6557
Email
Jeannine.Garnett@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuojen Tsao, MD
Organizational Affiliation
The University of Texas Health Science Center at Houston - UTHealth.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuojen Tsao, MD
Phone
713-500-7327
Email
KuoJen.Tsao@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Jeannine Garnett, PhD
Phone
(713) 486-6557
Email
Jeannine.Garnett@uth.tmc.edu
Facility Name
The Fetal Center at UTHealth
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuojen Tsao, MD
Phone
713-500-7327
Email
KuoJen.Tsao@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Jeannine Garnett, PhD
Phone
(713) 486-6557
Email
Jeannine.Garnett@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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
background
Links:
URL
http://childrens.memorialhermann.org/the-fetal-center/
Description
The Fetal Center at Children's Memorial Hermann Hospital

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Extended Criteria For Fetal Myelomeningocele Repair

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