Fetal Myelomeningocele Repair With Maternal BMI Between 35.0 and 40.0
| Status: | Terminated |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 6/30/2018 |
| Start Date: | July 2015 |
| End Date: | May 2017 |
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.
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.
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.
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.
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)
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