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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02664207
Other study ID # HSC-MS-15-0795
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 26, 2016
Est. completion date December 2023

Study information

Verified date May 2024
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender Female
Age group 16 Years to 45 Years
Eligibility 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)

Study Design


Intervention

Procedure:
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

Locations

Country Name City State
United States Children's Memorial Hermann Hospital Houston Texas
United States The Fetal Center at UTHealth Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Post-operative complications Determine if there is an increased risk in women in this group At the time of fetal repair surgery to 40 weeks gestation
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