Last updated: May 6, 2024
Sponsor: The University of Texas Health Science Center, Houston
Overall Status: Completed
Phase
N/A
Condition
Birth Defects
Diabetes Prevention
Obesity
Treatment
Open Fetal Repair of Myelomeningocele
Clinical Study ID
NCT02664207
HSC-MS-15-0795
Ages 16-45 Female
Study Summary
Eligibility Criteria
Inclusion
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 therisk of prematurity. For example cleft lip and palate, minor ventricular septaldefect, pyelectasis.
- Maternal Rh alloimmunization. Must have a low level of anti-red blood cell antibodythat is not associated with fetal disease, specifically anti-E < 1:4 or anti-M. Oralloimmunization with negative fetal red blood cell antigen status determined byamniocentesis.
- same MOMs Trial inclusion criteria with the exception of the above.
Exclusion
Exclusion Criteria:
- poor glycemic control (i.e., HbA1c ≥ 8%) in spite a medical antidiabetic therapy inaccordance 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)
Study Design
Total Participants: 12
Treatment Group(s): 1
Primary Treatment: Open Fetal Repair of Myelomeningocele
Phase:
Study Start date:
January 26, 2016
Estimated Completion Date:
December 31, 2023
Study Description
Connect with a study center
Children's Memorial Hermann Hospital
Houston, Texas 77030
United StatesSite Not Available
The Fetal Center at UTHealth
Houston, Texas 77030
United StatesSite Not Available

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