Fetal Myelomeningocele Repair With Maternal BMI Between 35.0 and 40.0
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Co-morbidities in mothers having fetal MMC repair
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
BMI 35.0 to 40.0
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
干预措施: Open Fetal Repair of Myelomeningocele (Procedure)
结局指标
主要结局
Co-morbidities in mothers having fetal MMC repair
时间窗: 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.
次要结局
未报告次要终点