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Safety Assessment Clinical Test of Fetal Surgery for Myelomeningocele

Safety Assessment Clinical Test of Fetal Surgery for Myelomeningocele - Safety Assessment Clinical Test of Fetal Surgery for Myelomeningocele

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000040088
Enrollment
15
Registered
2020-04-07
Start date
2021-04-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelomeningocele

Interventions

Sponsors

OSAKA University Department of Medicine Division of Obstetrics and Gynecology
Lead Sponsor
National Center for Child Health and Development
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Myelomeningocele at level T1 through S1 With evidence of hindbrain herniation at least 20 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

MeasureTime frame
Hindbrain herniation at the age of 12 months

Secondary

MeasureTime frame
the need for placement of a cerebrospinal fluid shunt by the age of 12 months Accomplishments of the fetal surgery Maternal Adverse Events Fetal Adverse Events

Countries

Japan

Contacts

Public ContactMASAYUKI ENDO

Osaka University Division of Medicine, Obstetrics and Gynecology

mendoh@sahs.med.osaka-u.ac.jp81668793351

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026