Extended Criteria For Fetal Myelomeningocele Repair

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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Key information

Conditions

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

Age range

16 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Children's Memorial Hermann Hospital, Houston, Texas, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

Post-operative complications

Time frame: At the time of fetal repair surgery to 40 weeks gestation

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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Extended Criteria For Fetal Myelomeningocele Repair: A Pilot Study

Important dates

Study start: 2016
Primary completion: 2023
Study completion: 2023
First posted: Jan 26, 2016
Registry last updated: May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed