Fetoscopic Laser Photocoagulation in Management of Vasa Previa - FLUMEN Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Placental function
研究概览
简要总结
In this research study, the investigators want to learn more about the safety and effectiveness of a fetal surgery, known as fetoscopic laser photocoagulation (FLP), for the treatment of a pregnancy condition called vasa previa (VP). Vasa previa is a pregnancy complication that happens when blood vessels from the fetus grow over the entrance to the womb. In a VP pregnancy, natural vaginal birth is deadly for the baby in more than half of cases due to the bursting of VP vessels and severe blood loss. Currently, VP patients are recommended to be closely monitored and often hospitalized once they reach the third trimester of pregnancy. An early delivery by C-section would typically be performed in order to avoid breaking the exposed fetal vessels.
Fetoscopic laser photocoagulation is a minimally invasive surgery in the womb to remove or correct abnormal blood vessels and tissues. In the FLP procedure, the surgeon uses a fetoscope (a tiny telescope) and a laser device to seal off unprotected vessels. While this surgery has been used to treat other pregnancy conditions, it has not yet been proven to be safe and/or effective for the treatment of vasa previa. This treatment aims to eliminate the VP, and, if successful, may have the potential to minimize the risk of bleeding, thereby enabling patients to avoid long hospitalization before delivery. This procedure may enable VP patients to have a vaginal delivery instead of C-section.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant patient
- •Singleton pregnancy
- •Confirmed diagnosis of vasa previa, defined as unprotected fetal vessels running through the membranes at or within 5cm of the internal cervical os. Diagnosis must be confirmed after 26w0d, and before 32w5d
- •Able to undergo intervention during 30w0d to 32w6d
- •Type II vasa previa in which one placental lobe is considered to be accessory, defined as constituting less than 20% of the total placental mass seen on MRI and US imaging
- •Type II vasa previa in which multiple bridging vessels connect the two placental lobes (≥4 vessels), and only 1-2 vessel(s) run through or within 5cm of the internal cervical os
- •Patient is eligible to undergo anesthesia
- •Patient and biological father of the fetus (if available) are able to provide signed informed consent
排除标准
- •Gestational age at referral higher than 32w6d
- •Multiple pregnancy
- •Vasa previa types I and III
- •Type II vasa previa in which the accessory lobe constitutes more than 20% of the total placental mass, as determined by the fetal surgeon during diagnostic fetoscopy
- •Type II vasa previa in which all of the bridging vessels between placental lobes are running over the internal cervical os
- •Fetal growth restriction, defined as estimated fetal weight or abdominal circumference less than the 10th percentile for gestational age
- •Abnormal fetal brain MRI, including delayed maturation, hemorrhage, arterial ischemic injury, abnormal ventricular size, or any congenital anomalies
- •Allergy or previous adverse reaction to ancillary medications with no available alternative
- •Preterm contractions and PPROM before surgery
- •Preeclampsia or uterine anomaly during the current pregnancy
- •Placenta previa, low-lying placenta, placenta accreta spectrum disorder
- •Suspicion of major recognized congenital syndrome on ultrasound or MRI that is not compatible with postnatal life
- •Maternal pre-pregnancy BMI >40
- •Active hepatitis B, hepatitis C, or HIV infection
- •High risk for congenital fetal bleeding disorders
- •Unreliable pregnancy dating due to an irregular menstrual cycle/uncertain last menstrual period with no confirmed dating from first trimester ultrasound
- •The surgeon determines that the procedure is not feasible for any other reason after diagnostic fetoscopy
研究组 & 干预措施
Fetoscopic Laser Photocoagulation Surgery
Pregnant individuals diagnosed with type II vasa previa will undergo fetoscopic laser photocoagulation.
干预措施: Fetoscopic Laser Photocoagulation (Device)
结局指标
主要结局
Placental function
时间窗: Two weeks after the last (20th) participant undergoes FLP surgery, about 3 years from study start date.
Successful maintenance of placental function after surgery. This will be measured by MRI 2 weeks after surgery.
Mode of delivery
时间窗: When the last (20th) participant reaches delivery, a little more than 3 years from study start date
The type of delivery, categorized as vaginal, assisted vaginal, or cesarean section.
Gestational age at delivery
时间窗: When the last (20th) participant reaches delivery, a little more than 3 years from study start date
The duration of pregnancy, measured in completed \[weeks + days\] from the first day of the last menstrual period (in individuals with regular menses and reliable dating) or determined through first-trimester ultrasound using fetal biometric measurements.
Successful visualization and mapping of vasa previa
时间窗: When the last (20th) participant undergoes FLP surgery, about 3 years from study start date.
Confirmation by the performing surgeon that the visualization and mapping of vasa previa by diagnostic fetoscopy matches imaging from US and MRI.
The rate of successful coagulation of the vasa previa - postoperative imaging
时间窗: Two weeks after the last (20th) participant undergoes FLP surgery, about 3 years from study start date.
Confirmation of the complete coagulation of the vasa previa including the absence of blood flow in involved vessels. This will be measured 2 weeks post-surgery by ultrasound and MRI.
The rate of successful coagulation of the vasa previa - intraoperative imaging
时间窗: When the last (20th) participant undergoes FLP surgery, about 3 years from study start date.
Confirmation of the complete coagulation of the vasa previa including the absence of blood flow in involved vessels. This will be measured in the OR directly after FLP surgery by ultrasound.
The rate of successful coagulation of the vasa previa - pathology
时间窗: When the last (20th) participant reaches delivery, a little more than 3 years from study start date
Confirmation of the complete coagulation of the vasa previa including the absence of blood flow in involved vessels. This will be measured after delivery during placental analysis by pathology.
次要结局
- GA at hospital admission(When the last (20th) participant is admitted to the hospital, a little less than 3 years from study start date)
- The rate of preterm premature rupture of membranes (PPROM)(When the last (20th) participant reaches delivery, a little more than 3 years from study start date)
- Duration of hospital stay(When the last (20th) participant is discharged from the hospital, a little more than 3 years from study start date)
- Cause for hospital admission(When the last (20th) participant is admitted to the hospital, a little less than 3 years from study start date)
- The rate of chorioamniotic separation(When the last (20th) participant reaches delivery, a little more than 3 years from study start date)
- Fetal brain structure(Two weeks after the last (20th) participant undergoes FLP surgery, about 3 years from study start date)
- The rate of spontaneous preterm labor(When the last (20th) participant reaches delivery, a little more than 3 years from study start date)
- Maternal mental health score(Two weeks after the last (20th) participant undergoes FLP surgery, about 3 years from study start date)
- Postnatal examination of the placenta(When the last (20th) participant reaches delivery, a little more than 3 years from study start date)
- The rate of placental abruption(When the last (20th) participant reaches delivery, a little more than 3 years from study start date)
- Interval from procedure to delivery(When the last (20th) participant reaches delivery, a little more than 3 years from study start date)
- The rate of chorioamnionitis(When the last (20th) participant reaches delivery, a little more than 3 years from study start date)
- NICU length of stay(When the last baby is discharged from the NICU, a little more than 3 years from study start date)
- Neonatal survival(When the last baby is discharged from the hospital, a little more than 3 years from study start date)
- The rate of fetal growth restriction(When the last (20th) participant reaches delivery, a little more than 3 years from study start date)
- The rate of NICU admission(When the last (20th) participant reaches delivery, a little more than 3 years from study start date)
- Short term neonatal morbidity(When the last baby is discharged from the hospital, a little more than 3 years from study start date)
研究者
Alireza Shamshirsaz
Chief, Division of Fetal Medicine and Surgery; Director, Maternal Fetal Care Center
Boston Children's Hospital