Clinical trial NCT02664207: Extended Criteria For Fetal Myelomeningocele Repair
Official title: Extended Criteria For Fetal Myelomeningocele Repair: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2016-01-26
Enrollment: 12
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Post-operative complications
timeFrame: At the time of fetal repair surgery to 40 weeks gestation
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Children's Memorial Hermann Hospital
state: Texas
city: Houston
country: United States
facility: The Fetal Center at UTHealth
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at Houston - UTHealth.
name: Kuojen Tsao, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.