Extended Criteria For Fetal Myelomeningocele Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-26

Study Completion Date

2023-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Obesity Myelomeningocele Pregnancy Diabetes Mellitus in Pregnancy Fetal Anomaly

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fetal Surgery in Women with ex

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

Group Type EXPERIMENTAL

Open Fetal Repair of Myelomeningocele

Intervention Type 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

Interventions

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Open Fetal Repair of Myelomeningocele

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

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

Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No