Pregnancy Clinical Trial
— MOMSto40BMIOfficial title:
Fetal Myelomeningocele Repair With Maternal BMI Between 35.0 and 40.0
NCT number | NCT02509377 |
Other study ID # | 24890 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2015 |
Est. completion date | May 2017 |
Verified date | June 2017 |
Source | St. Louis University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 1 |
Est. completion date | May 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - History of maternal alloimmunization problem - Kell sensitization - Risk of preterm birth - History of spontaneous preterm birth - Cervix <20mm in length - Presence of cerclage - 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) |
Country | Name | City | State |
---|---|---|---|
United States | SSM Cardinal Glennon Fetal Care Institute | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
St. Louis University |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | up to 40 weeks |
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