Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction (LUTO): A Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Number of participants where the etiology of LUTO was correctly diagnosed
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Fetal Cystoscopy Group
Participants in this group will receive the fetal cystoscopy procedure around 16 weeks 0 days to 25 weeks and 6 days of gestation.
干预措施: Fetoscopes (Device)
Fetal Cystoscopy Group
Participants in this group will receive the fetal cystoscopy procedure around 16 weeks 0 days to 25 weeks and 6 days of gestation.
干预措施: Fetal Cystoscopy (Procedure)
结局指标
主要结局
Number of participants where the etiology of LUTO was correctly diagnosed
时间窗: Up to 1 month post delivery
Number of participants where the etiology of LUTO was correctly diagnosed during fetal cystoscopy as compared to post natal cystoscopy
Number of participants whose fetal cystoscopy resulted in the prevention of post-natal severe pulmonary hypoplasia
时间窗: Up to 1 month post delivery
As per treating physician evaluation of clinical assessments post-natal.
Number of participants whose fetal cystoscopy resulted in the prevention of post-natal severe renal impairment
时间窗: Up to 24 months post delivery
As per treating physician evaluation of clinical assessments post-natal.
Number of participants where the procedure was technically performed
时间窗: Day 1 (Post fetal cystoscopy procedure)
Number of participants where the fetal cystoscopy procedure was successfully technically performed.
Number of participants where the posterior urethral valve were successfully released
时间窗: Day 1 (Post fetal cystoscopy procedure)
Number of participants where the posterior urethral valve were successfully released
Number of participants whose fetal cystoscopy resulted in maternal complications
时间窗: Day 1 post delivery
Maternal and obstetrical complications such as preterm premature rupture of the membranes (PPROM), prematurity (birth \<37 weeks), extremely preterm birth (\<32 weeks), and urological fistulae and fetal demise.
次要结局
未报告次要终点
研究者
Rodrigo Ruano
Professor
University of Miami