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In Utero Surgery of Fetal Lesions to the Spinal Cord: outcomes of the surgery, mothers and newborns

Terminated
Conditions
Myelomeningocele
Registration Number
RBR-4zfbkqv
Lead Sponsor
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Brief Summary

Most common surgery complications were preterm premature rupture of membranes, preterm birth and chorioamnionitis. Risk factors associated with VPS were ventricle size before surgery, gestational age at surgery and lesion level.

Detailed Description

Not available

Recruitment & Eligibility

Status
Terminated
Sex
Not specified
Target Recruitment
Not specified
Inclusion Criteria

Singleton pregnancy; Myelomeningocele with the upper boundary located between T1 and S1; Evidence of hindbrain herniation; Gestational age of 19.0 to 25.9 weeks at randomization
Normal karyotype; Maternal age of at least 18 years

Exclusion Criteria

A fetal anomaly unrelated to myelomeningocele; Severe kyphosis; Risk of preterm birth (including short cervix and previous preterm birth); Placental abruption; Body-mass index of 35 or more; Contraindication to surgery, including previous hysterotomy in the active uterine segment

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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