Extended Criteria For Fetal Myelomeningocele Repair

Obesity Clinical Trial

Official title:

Extended Criteria For Fetal Myelomeningocele Repair: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02664207
• Other study ID #: HSC-MS-15-0795
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Congenital Abnormalities
• Diabetes Mellitus in Pregnancy
• Fetal Anomaly
• Meningomyelocele
• Myelomeningocele
• Obesity
• Pregnancy
• Pregnancy in Diabetics

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

External Links

•   The Fetal Center at Children's Memorial Hermann Hospital