Trial NCT06056635
A Prospective Study on the Role of Karl Storz Curved and Straight Fetoscopes (11508AAK and 11506AAK) for Fetoscopic Intrauterine Procedures
- Phase
- Not given
- Sponsor
- Boston Children's Hospital
- Conditions
- Fetal Conditions; Maternal; Procedure; Pregnancy Related; Twin to Twin Transfusion Syndrome; In Utero Procedure Affecting Fetus or Newborn; Chorion; Abnormal; Twin Reversal Arterial Perfusion Syndrome; Twin Monochorionic Monoamniotic Placenta; Chorioangioma; Vasa Previa
- Ages
- 18–45 years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Inclusion Criteria:
* Pregnant patient with a condition requiring in-utero surgery
* Patient must be eligible for anesthesia
* Patient and father of the fetus (if available) are able to provide signed informed consent
Exclusion Criteria:
* Allergy or previous adverse reaction to any ancillary medication specified in this protocol that has no alternative
* Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy
* Suspicion of major recognized congenital syndrome on ultrasound or MRI that is not compatible with postnatal life
* Pre-pregnancy maternal BMI greater than 40BMI
* High risk for fetal hemophilia
* Fetal aneuploidy or variants of known significance if an amniocentesis was performed
* Contraindication to abdominal surgery or fetoscopic surgery
Restrictions found (1)
- BMIOutrightexclusion
BMI > 40
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Recruiting in Massachusetts
- Boston Children's Hospital · Boston, Suffolk County