Extended Criteria For Fetal Myelomeningocele Repair

Completed · Not applicable

Conditions studied: Obesity, Myelomeningocele, Pregnancy, Diabetes Mellitus in Pregnancy, Fetal Anomaly

In brief

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

Key facts

Study ID

NCT02664207

Run by

The University of Texas Health Science Center, Houston

People needed

12

Starts

2016-01-26

Expected to finish

2023-12-01

Last updated by the study team

2024-05-08

Who can join

Age: 16 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

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

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

Where it is running

• Children's Memorial Hermann Hospital — Houston, Texas, United States
• The Fetal Center at UTHealth — Houston, Texas, United States

Full record on ClinicalTrials.gov

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