NCT02664207Completed
Extended Criteria For Fetal Myelomeningocele Repair
Extended Criteria For Fetal Myelomeningocele Repair: A Pilot Study
Source: ClinicalTrials.gov · Last updated 8 May 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 19 Jan 2016
- Start date
- 26 Jan 2016
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Diseases
- Obesity
- NCT number
- NCT02664207
What you commit to
- Study type: Interventional
- Participants enrolled: 12
- From 26 Jan 2016 to the primary completion date, 31 Dec 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- poor glycemic control (i.e., HbA1c ≥ 8%) in spite a medical antidiabetic therapy in accordance with good clinical practice (GCP)
Other
- same MOMs Trial exclusion criteria (with the exception of extended inclusion criteria)
Who the study is looking for
- 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.
Age in the registry: 16 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Memorial Hermann Hospital Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| The Fetal Center at UTHealth Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.