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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00026102

Enrollment

Registered

2021-08-23

Start date

2021-07-14

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Q05.9

Interventions

Group 1: The operation will be carried out according to current standard protocol, as a hybrid of the Fetoscopic Myelomeningocele Repair Consortium externalization of the uterus, entering with 2 – 3 t

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactCorinna Keil

Universitätsklinikum Giessen und Marburg, Standort Marburg

corinna.keil@med.uni-marburg.de06421 58 66213

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026