MyelomeningoceleMOMSto40BMINCT02509377
Fetal Myelomeningocele Repair With Maternal BMI Between 35.0 and 40.0
A study testing Open Fetal Repair of Myelomeningocele in people with Myelomeningocele and Pregnancy, run by St. Louis University at 1 site in United States.
Trial summary
Inclusion and exclusion criteria for fetal repair of MMC was established by the Management of Myelomeningocele Study (MOMS Trial) and these criteria are the standard of care throughout the United States. These criteria state exclusion for hypertension and diabetes which are known co-morbidities for obesity. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Myelomeningocele, Pregnancy
- What is being tested?
- Open Fetal Repair of Myelomeningocele
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to May 2017
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Maternal BMI 35.0 to 40.0
- No maternal documented co-morbidities
- Fetal MMC begins between thoracic 1 and sacral 1, on the spinal column.
- Evidence of fetal hindbrain herniation (hindbrain is being pulled down the spinal column).
- A gestational age is between 19 weeks 0 days and 26 weeks with evidence of placental membrane fusion.
- Documented normal fetal karyotype.
Who cannot join
- History of maternal alloimmunization problem
- Kell sensitization
- Risk of preterm birth
- History of spontaneous preterm birth
- Cervix <20mm in length
- Presence of cerclage
Show all 26Show fewer
- Placental problem
- History of placental abruption
- Placental Previa
- Body-mass index of 40.1 or more
- Maternal contraindication to surgery
- Insulin-dependent pregestational diabetes
- Hypertension or preeclampsia
- HIV, hepatitis-B, or hepatitis-C positive
- Other medical condition of risk to mother
- Uterine problem
- Previous hysterotomy in the active uterine segment
- Severe fibroids
- Uterine malformation (bicornuate, arcuate, unicornuate, didelphys)
- No support person for periprocedural period
- Inadequate support at home for pregnancy
- Inadequate understanding of risks and benefits of fetal surgery
- Inability to comply with medical restrictions, follow up after fetal surgery
- Multiple gestation pregnancy (twins, triplets, etc.)
- A fetal anomaly unrelated to myelomeningocele (heart defect, lung lesions)
- Severe fetal kyphosis >30 degrees (curvature of the back)
Trial locations and contacts
1 site in 1 country.
United States1 site
SSM Cardinal Glennon Fetal Care Institute
St Louis, Missouri, 63104
About this study
Inclusion and exclusion criteria for fetal repair of MMC was established by the Management of Myelomeningocele Study (MOMS Trial) and these criteria are the standard of care throughout the United States. These criteria state exclusion for hypertension and diabetes which are known co-morbidities for obesity. Investigators plan to expand one exclusion criteria for open fetal repair surgery. Currently, an exclusion factor is a maternal BMI of 35.0 and greater.Investigators will maintain all other inclusion and exclusion criteria (including excluding for hypertension and diabetes) with the exception of expanding the BMI to include mothers with a BMI of 35.0 to 40.0. Co-morbidities of the research group will be compared to the comorbidities of the mothers published in the MOMS trial.
Read the detailed description
The MOMS trial proved prenatal repair of myelomeningocele was an advantage over postnatal repair for the fetus/neonate/child and is the standard of care for maternal/fetal dyads who meet the inclusion exclusion criteria. Investigators plan to maintain all inclusion exclusion criteria for open fetal repair surgery of myelomeningocele with one exception, the expansion of the maternal BMI to 40.0. This population of mothers with a BMI of 35.0 to 40.0 have not been studied. The morbidities of these mothers will be compared to morbidities of mothers with a BMI less than or equal to 34.9 currently in the scientific literature.
- Conditions
- Myelomeningocele, Pregnancy
- Being tested
- Open Fetal Repair of Myelomeningocele
- Keywords
- Fetal Surgery, Open Fetal Surgery, Elevated BMI, Body Mass Index, Spina Bifida
- Medical subject headings
- Meningomyelocele, Spinal Dysraphism
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
Open Fetal Repair of Myelomeningocele when mothers BMI is elevated
| Study group | Role | What they receive |
|---|---|---|
| BMI 35.0 to 40.0 | Experimental | Mothers who meet all inclusion exclusion criteria for open fetal repair of myelomeningocele except BMI.
These mothers have a BMI between 35.0 and 40.0 Receives: Procedure: Open Fetal Repair of Myelomeningocele |
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-morbidities in mothers having fetal MMC repair
Measure the co-morbidity of mothers with a BMI of 35.0 to 40.0. Compare to published data in the MOMS trial.
Measured: up to 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionMay 2017
- Study completionMay 2017
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 MyelomeningoceleStudies of the same condition, open and under way.
- 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emanuel Vlastos, Associate Professor, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509377
- Sponsor's protocol ID
- 24890
- Acronym
- MOMSto40BMI
- Status last verified
- Jun 2017
- First submitted
- 23 Jul 2015
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
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 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Myelomeningocele Repair With Maternal BMI Between 35.0 and 40.0
- ClinicalTrials.gov ID
- NCT02509377
- Acronym / sponsor ID
- MOMSto40BMI / 24890
- Conditions
- Myelomeningocele, Pregnancy
- Keywords
- Fetal Surgery, Open Fetal Surgery, Elevated BMI, Body Mass Index, Spina Bifida
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 28 Jul 2015 (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.
Inclusion and exclusion criteria for fetal repair of MMC was established by the Management of Myelomeningocele Study (MOMS Trial) and these criteria are the standard of care throughout the United States. These criteria state exclusion for hypertension and diabetes which are known co-morbidities for obesity. Investigators plan to expand one exclusion criteria for open fetal repair surgery. Currently, an exclusion factor is a maternal BMI of 35.0 and greater.Investigators will maintain all other inclusion and exclusion criteria (including excluding for hypertension and diabetes) with the exception of expanding the BMI to include mothers with a BMI of 35.0 to 40.0. Co-morbidities of the research group will be compared to the comorbidities of the mothers published in the MOMS trial.
Detailed description
The MOMS trial proved prenatal repair of myelomeningocele was an advantage over postnatal repair for the fetus/neonate/child and is the standard of care for maternal/fetal dyads who meet the inclusion exclusion criteria. Investigators plan to maintain all inclusion exclusion criteria for open fetal repair surgery of myelomeningocele with one exception, the expansion of the maternal BMI to 40.0. This population of mothers with a BMI of 35.0 to 40.0 have not been studied. The morbidities of these mothers will be compared to morbidities of mothers with a BMI less than or equal to 34.9 currently in the scientific literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMI 35.0 to 40.0 | Experimental | Procedure: Open Fetal Repair of MyelomeningoceleMothers who meet all inclusion exclusion criteria for open fetal repair of myelomeningocele except BMI. These mothers have a BMI between 35.0 and 40.0 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Maternal BMI 35.0 to 40.0
- No maternal documented co-morbidities
- Fetal MMC begins between thoracic 1 and sacral 1, on the spinal column.
- Evidence of fetal hindbrain herniation (hindbrain is being pulled down the spinal column).
- A gestational age is between 19 weeks 0 days and 26 weeks with evidence of placental membrane fusion.
Key exclusion criteria (26 listed)
- History of maternal alloimmunization problem
- Kell sensitization
- Risk of preterm birth
- History of spontaneous preterm birth
- Cervix <20mm in length
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 MyelomeningoceleOpen Fetal Repair of Myelomeningocele when mothers BMI is elevated | Procedure or surgery | BMI 35.0 to 40.0 |
Primary outcome
Co-morbidities in mothers having fetal MMC repair
Time frame: up to 40 weeks
Measure the co-morbidity of mothers with a BMI of 35.0 to 40.0. Compare to published data in the MOMS trial.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Results publication: 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.
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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.
Emanuel Vlastos, Associate Professor principal investigator
St. Louis University
1 site 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 Myelomeningocele and Pregnancy, run by St. Louis University at 1 site 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 6 inclusion and 26 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: stopped early, as of the sponsor's last update on 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early. Results are not available in the source record.
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?
Co-morbidities in mothers having fetal MMC repair (time frame: up to 40 weeks). 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 NCT02509377, 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 28 Jun 2018.