Myelomeningocele
Conditions
Interventions
Sponsors
The University of OSAKA
National Center for Child Health and Development
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Myelomeningocele at level T1 through S1 With evidence of hindbrain herniation at least 18 years old of maternal age 19+0 to 25+6 weeks of gestational age Singleton pregnancy
Exclusion criteria
Exclusion criteria: Additional fetal anomalies not related with MMC HIV or Hepatitis B/C positive Increased risk for preterm delivery: short cervix, cervical incompetency, uterine anomaly, previa, prior spontaneous preterm delivery Multifetal pregnancy Previous hysterotomy Prior abruptio placentae Kyphosis in the fetus of 30 degrees or more Insulin dependent pregestational diabetes Rh isoimmunization Body mass index > 35 Patient does not have a support person. Psychosocial issues preventing compliance Other contraindications to elective surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of hindbrain herniation at 12 months after birth | — |
Secondary
| Measure | Time frame |
|---|---|
| 1, Efficacy endpoints (1) Intraventriculo-abdominal shunt at 12 months of age (2) Infant mortality up to 12 months after birth (3) Completion of surgery Safety endpoints (1) Maternal adverse events (2) Fetal/infant adverse events Other endpoints (1) Maternal endpoints Preterm delivery within 4 weeks after surgery Weeks of gestation at delivery (2) Fetal/infant endpoints Chiari malformation length of the hypoplasia Presence of hydrocephalus Presence/absence of lower extremity deformity Lower extremity motor function (3) Laboratory tests (blood and urine tests) Hematological tests (WBC, RBC, Hb, Ht, Plt, WBC fraction) Biochemical tests (AST, ALT, TP, CRP, creatinine) Urinalysis (protein qualitative, sugar qualitative) | — |
Countries
Japan
Contacts
Public ContactMASAYUKI ENDO
THE UNIVERSITY OF OSAKA Division of Medicine, Obstetrics and Gynecology
Outcome results
None listed