Myelomeningocele
Conditions
Interventions
The study type was cross-sectional observational. Pregnant women with singleton pregnancies of babies with myelomeningocele between 19-26+6 weeks of gestational age were submitted to prenatal repair o
V03.175.500
Sponsors
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: We aimed to know the prevalence of obstetric outcomes such as premature rupture of membranes, preterm birth and chorioamnionitis in our population undergoing prenatal repair of spina bifida through a mini-hysterotomy. ;Real outcome 1: the prevalence of premature rupture of membranes was 46.2%, preterm birth was 76.9% and chorioamnionitis was 33.3%. Statistical analysis used the Student t test or the Mann–Whitney test, chi-square test or Fisher's exact test, as well as logistic regression models to estimate odds-ratios and 95% confidence intervals. ;Expected outcome 2: evaluate risk factors associated with ventriculoperitoenal shunting at 12 months of life using logistic regression models.;Real outcome 2: risk factors for ventriculoperitoneal shunting (VPS) at 12 months were estimated using Poisson regression models, which worked better for our study design and prevalence of the outcome studied. The risk factors associated with VPS in our population were the size of the lateral ventricle before surgery, gestational age at surgery and lesion level. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes were not expected | — |
Countries
Brazil
Contacts
Public ContactLuana Rocha
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed