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

niversitätsklinikum Giessen und Marburg, Standort Giessen0 个研究点目标入组 50 人开始时间: 2021年8月23日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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

•- 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

发起方

niversitätsklinikum Giessen und Marburg, Standort Giessen