Prenatel surgery of the fetal spina bifida in hybrid method within the fetoscopic Myelomeningocele Repair Consortium

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 50

Inclusion Criteria

age >/= 18 years
-Informed Consent
-Localisation of defect between Th1 and S1 and -Arnorld Chiari II malformation (confirmation by MRI)
-Gestational age between 19+0 – 28+0 weeks when operation
-normal karyotype

Exclusion Criteria

- A multiple pregnancy (twins)
- A cervix length of < 25 mm (established through transvaginal sonography)
sonography)
- A cerclage (planned or in place) or a cervix closure
- A anamnestic risk of premature birth (condition resulting from cervical insufficiency) or spontaneous partum <37+ week by a single pregnancy
- Placenta praevia, placental abruption

- Fetal abnormalities not associated with the malformation of the central nervous system, (fetal-echography before obligatory randomization);
- Obesity (BMI * 35 kg/m2);
- A prior, insulin dependent diabetes mellitus (type I or II)
- An arterial, maternal hypertension (not arterial or chronic with end organ damage, newly developed hypertension during the current pregnancy)
- A kyphosis of 30°
- A Rh or Kell sensitivity, condition following neonatal alloimmune-thrombocytopenia (NAIT)
- A maternal infection with HIV, hepatitis B or C, uterine abnormalities or large/multiple myomas
- Maternal contraindications, for example hysterectomy in the active uterine segment, extended myoma enucleation, previous fetal surgery; insufficiently supportive social environment; difficulty in committing to post-treatment observation appointments at the Center; participation in another intervention study through which the maternal or fetal morbidity or mortality would be influenced, or, pre-pregnancy participation in the study

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intrauterine death of fetus (IUFD); <br>Birthweight<br>Artificial respiration <br>Brain hemorrhage<br>Fetal retinopathy<br><br>Necessity of shunt after 12, 24 und 30 months functional level of free (unassisted) walking Continence<br>Necessity of catheterization<br>Necessity of post-partum revision<br>Neurological development up to 30 months post-partum<br><br><br>Maternal primary outcome parameter: <br>Gestational age<br>Premature rupture of the amnionic sack (PPROM)<br>Amnion separation<br>Detachment of the placenta<br>Amnio infection syndrome <br>Sectio rate <br>Wound dehiscence<br>

Secondary Outcome Measures