Fetoscopic Laser Photocoagulation in Management of Vasa Previa

NCT06290232 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: IRB-P00044498
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vasa Previa; Pregnancy Complications; Maternal; Procedure; In Utero Procedure Affecting Fetus or Newborn

Keywords

Fetoscope; Fetoscopic Laser Photocoagulation; Low-Lying Fetal Vessels

Outcome Measures

Primary Outcomes (7)

• Mode of delivery

  The type of delivery, categorized as vaginal, assisted vaginal, or cesarean section.

  When the last (20th) participant reaches delivery, a little more than 3 years from study start date

• Gestational age at delivery

  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.

  When the last (20th) participant reaches delivery, a little more than 3 years from study start date

• Successful visualization and mapping of vasa previa

  Confirmation by the performing surgeon that the visualization and mapping of vasa previa by diagnostic fetoscopy matches imaging from US and MRI.

  When the last (20th) participant undergoes FLP surgery, about 3 years from study start date.

• The rate of successful coagulation of the vasa previa - intraoperative imaging

  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.

  When the last (20th) participant undergoes FLP surgery, about 3 years from study start date.

• The rate of successful coagulation of the vasa previa - postoperative imaging

  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.

  Two weeks after the last (20th) participant undergoes FLP surgery, about 3 years from study start date.

• The rate of successful coagulation of the vasa previa - pathology

  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.

  When the last (20th) participant reaches delivery, a little more than 3 years from study start date

• Placental function

  Successful maintenance of placental function after surgery. This will be measured by MRI 2 weeks after surgery.

  Two weeks after the last (20th) participant undergoes FLP surgery, about 3 years from study start date.

Secondary Outcomes (17)

• GA at hospital admission

  When the last (20th) participant is admitted to the hospital, a little less 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 spontaneous preterm labor

  When the last (20th) participant reaches delivery, a little more 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

Study Arms (1)

Fetoscopic Laser Photocoagulation Surgery

EXPERIMENTAL

Pregnant individuals diagnosed with type II vasa previa will undergo fetoscopic laser photocoagulation.

Device: Fetoscopic Laser Photocoagulation

Interventions

Fetoscopic Laser Photocoagulation DEVICE

Pregnant patients diagnosed with type II vasa previa will undergo fetoscopic laser photocoagulation of the involved fetal vessels. FLP will be performed laparoscopically using a fetoscope (tiny telescope) and a laser device inside of the womb. This procedure will be completed at 30w0d to 32w6d gestational age.

Also known as: Fetoscopic Laser Ablation

Fetoscopic Laser Photocoagulation Surgery

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (58)

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MeSH Terms

Conditions

Vasa Previa; Pregnancy Complications

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Alireza Shamshirsaz, MD

  Director, Maternal Fetal Care Center; Chief, Division of Fetal Medicine and Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brittany E Gudanowski

CONTACT

617-919-6658; Brittany.Gudanowski@childrens.harvard.edu

Ali Javinani, MD

CONTACT

ali.javinani@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Fetal Medicine and Surgery; Director, Maternal Fetal Care Center

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 4, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)