ObesityNCT02664207
Extended Criteria For Fetal Myelomeningocele Repair
A study testing Open Fetal Repair of Myelomeningocele in people with Obesity and Myelomeningocele, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Obesity, Myelomeningocele, Pregnancy
- What is being tested?
- Open Fetal Repair of Myelomeningocele
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Jan 2016to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Memorial Hermann Hospital
Houston, Texas, 77030
The Fetal Center at UTHealth
Houston, Texas, 77030
About this study
Official title: Extended Criteria For Fetal Myelomeningocele Repair: A Pilot Study
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
Read the detailed 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.
- Being tested
- Open Fetal Repair of Myelomeningocele
- Keywords
- Myelomeningocele repair, Open Neural Tube Defect, BMI of 35-40 kg/m2,, Open Fetal Surgery, Elevated body mass index
- Medical subject headings
- Obesity, Meningomyelocele, Diabetes, Gestational, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Fetal Repair of MyelomeningoceleProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Fetal Surgery in Women with ex | Experimental | Fetal myelomeningocele repair surgery will be offered to pregnant women meeting the criteria for surgery (as set by the MOMS trial) with the exception of the following:
* a BMI greater than 35 (but less than or equal to 40 kg/m2)
* (minor) Fetal structural abnormality
* (well-controlled) Diabetes
* Previous preterm delivery (followed by a full term delivery)
* Maternal red cell alloimmunization (must NOT be associated with fetal disease, OR fetus must have negative red cell antigen status as determined by amniocentesis).
Intervention: Open Fetal Repair of Myelomeningocele Receives: Procedure: Open Fetal Repair of Myelomeningocele |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative complications
Determine if there is an increased risk in women in this group
Measured: At the time of fetal repair surgery to 40 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study start26 Jan 2016
- Primary completionDec 2023
- Study completionDec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KuoJen Tsao, The University of Texas Health Science Center, Houston
- Investigators
- Kuojen Tsao, MD, Principal investigator, The University of Texas Health Science Center at Houston - UTHealth.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664207
- Sponsor's protocol ID
- HSC-MS-15-0795
- Status last verified
- May 2024
- First submitted
- 19 Jan 2016
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 21306277
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Criteria For Fetal Myelomeningocele Repair: A Pilot Study
- ClinicalTrials.gov ID
- NCT02664207
- Acronym / sponsor ID
- HSC-MS-15-0795
- Keywords
- Myelomeningocele repair, Open Neural Tube Defect, BMI of 35-40 kg/m2,, Open Fetal Surgery, Elevated body mass index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 26 Jan 2016
- Primary completion
- Dec 2023 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fetal Surgery in Women with ex | Experimental | Procedure: Open Fetal Repair of MyelomeningoceleFetal myelomeningocele repair surgery will be offered to pregnant women meeting the criteria for surgery (as set by the MOMS trial) with the exception of the following: * a BMI greater than 35 (but less than or equal to 40 kg/m2) * (minor) Fetal structural abnormality * (well-controlled) Diabetes * Previous preterm delivery (followed by a full term delivery) * Maternal red cell alloimmunization (must NOT be associated with fetal disease, OR fetus must have negative red cell antigen status as determined by amniocentesis). Intervention: Open Fetal Repair of Myelomeningocele |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open Fetal Repair of MyelomeningoceleFetal repair of myelomeningocele in women with additional medical factors that would have excluded them from this treatment under the MOMs trial inclusion/exclusion criteria | Procedure or surgery | Fetal Surgery in Women with ex |
Primary outcome
Post-operative complications
Time frame: At the time of fetal repair surgery to 40 weeks gestation
Determine if there is an increased risk in women in this group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background: PubMed 21306277Adzick 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.
- The Fetal Center at Children's Memorial Hermann HospitalLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuojen Tsao, MD principal investigator
The University of Texas Health Science Center at Houston - UTHealth.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open Fetal Repair of Myelomeningocele in people with Obesity and Myelomeningocele, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative complications (time frame: At the time of fetal repair surgery to 40 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02664207, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.