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Идёт набор NCT03281798

Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction

Без фазы С лечением Lower Urinary Tract Obstructive Syndrome Lower Urinary Tract Obstruction, Congenital Bladder Outlet Obstruction Bladder Outflow Obstruction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Fetoscopes, Fetal Cystoscopy.
Кому может быть актуально
Состояния в реестре: Lower Urinary Tract Obstructive Syndrome, Lower Urinary Tract Obstruction, Congenital, Bladder Outlet Obstruction, Bladder Outflow Obstruction. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction (LUTO): A Prospective Trial

Обзор

The purpose of the study is to study the outcomes of maternal and fetal patients who are undergoing fetal intervention for severe isolated lower urinary tract obstruction (LUTO).

Вмешательства

  • Устройство Fetoscopes
    Fetoscopes are telescopes developed for procedures involving fetal interventions and is inserted through the maternal abdomen.
  • Процедура Fetal Cystoscopy
    A fetoscope will be inserted into the fetal bladder via the maternal abdomen and advanced into the fetal bladder outlet. Identified obstruction will be opened using laser.

Первичные конечные точки

  • Number of participants where the procedure was technically performed [Срок оценки: Day 1 (Post fetal cystoscopy procedure)]
  • Number of participants where the etiology of LUTO was correctly diagnosed [Срок оценки: Up to 1 month post delivery]
  • Number of participants where the posterior urethral valve were successfully released [Срок оценки: Day 1 (Post fetal cystoscopy procedure)]
  • Number of participants whose fetal cystoscopy resulted in the prevention of post-natal severe pulmonary hypoplasia [Срок оценки: Up to 1 month post delivery]
  • Number of participants whose fetal cystoscopy resulted in the prevention of post-natal severe renal impairment [Срок оценки: Up to 24 months post delivery]
  • Number of participants whose fetal cystoscopy resulted in maternal complications [Срок оценки: Day 1 post delivery]

Критерии участия

Критерии включения

  • Pregnant women
  • Singleton pregnancy
  • Maternal age ≥ 18 years
  • Male fetus with LUTO, dilated bladder, "keyhole sign" and bilateral hydronephrosis
  • Oligohydramnios or Anhydramnios
  • Favorable urine analysis defined as urinary sodium is < 100 milliequivalents per liter (mEq/L), chloride < 90 mEq/L, and osmolality < 200 milliosmoles per kilogram (mOsm/kg) after 20 weeks and in the absence of previous in utero intervention for the disease (vesicoamniotic shunt placement or fetal cystoscopy).
  • Absence of chromosomal abnormalities and associated anomalies
  • Gestational age at the time of the procedure will be between 16 0/7 weeks and 25 6/7 weeks
  • Normal karyotype by invasive testing (amniocentesis or Chorionic Villus Sampling (CVS)). Patients declining invasive testing will be excluded.
  • Family have considered and declined the option of termination of the pregnancy at less than 24 weeks.
  • Family meets psychosocial criteria, including sufficient social support and ability to understand requirements of the study.
  • Parents or guardian are willing to provide signed informed consent.

Критерии исключения

  • Fetal anomaly unrelated to LUTO
  • Congenital cardiac anomaly
  • Female fetus
  • Increased risk for preterm labor including short cervical length (<1.5 cm), history of incompetent cervix with or without cerclage, and previous preterm birth
  • Placental abnormalities (previa, abruption, accreta) known at time of enrollment
  • Contraindications to surgery including previous hysterotomy in active uterine segment
  • Technical limitations precluding fetoscopic surgery, such as uterine fibroids, fetal membrane separation, uterine anomalies incompatible with fetoscopy
  • Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
  • Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment
  • Maternal medical condition that is a contraindication to surgery or anesthesia
  • Patient does not have health insurance to cover routine clinical care including prenatal care, prenatal ultrasound, amniocentesis, tocolysis, admission, delivery, and fetal vesico-amniotic shunting. The exception will be fetal cystoscopy which is considered an experimental procedure.
  • Inability to comply with travel and follow-up requirements of the trial
  • Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
  • Patients declining invasive testing
  • Family does not meet psychosocial criteria including insufficient

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • University of Miami — Miami
  • Mayo Clinic — Rochester

Идентификаторы

NCT: NCT03281798 · 20220117-1 · 16-008556

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗