Fetoscopic Laser Photocoagulation in Management of Vasa Previa (FLUMEN)

September 24, 2024 updated by: Alireza Shamshirsaz, Boston Children's Hospital

Fetoscopic Laser Photocoagulation in Management of Vasa Previa - FLUMEN Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fetoscopic Laser Photocoagulation Surgery
Pregnant individuals diagnosed with type II vasa previa will undergo fetoscopic laser photocoagulation.
Device: Fetoscopic Laser Photocoagulation
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.
Other Names:
  • Fetoscopic Laser Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mode of delivery
Time Frame: 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.
When the last (20th) participant reaches delivery, a little more than 3 years from study start date
Gestational age at delivery
Time Frame: 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.
When the last (20th) participant reaches delivery, a little more than 3 years from study start date
Successful visualization and mapping of vasa previa
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
When the last (20th) participant reaches delivery, a little more than 3 years from study start date
Placental function
Time Frame: 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.
Two weeks after the last (20th) participant undergoes FLP surgery, about 3 years from study start date.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GA at hospital admission
Time Frame: When the last (20th) participant is admitted to the hospital, a little less than 3 years from study start date
The gestational age at hospital admission before birth.
When the last (20th) participant is admitted to the hospital, a little less than 3 years from study start date
Duration of hospital stay
Time Frame: When the last (20th) participant is discharged from the hospital, a little more than 3 years from study start date
The length of hospital stay for the pregnant person will be recorded, from the time of admission to discharge.
When the last (20th) participant is discharged from the hospital, a little more than 3 years from study start date
Cause for hospital admission
Time Frame: When the last (20th) participant is admitted to the hospital, a little less than 3 years from study start date
The reason for hospital admission before birth will be recorded.
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
Time Frame: When the last (20th) participant reaches delivery, a little more than 3 years from study start date
The incidence of labor occurring naturally before 37 completed weeks of pregnancy with regular uterine contractions and progressive cervical dilation in the absence of medical or obstetric intervention.
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)
Time Frame: When the last (20th) participant reaches delivery, a little more than 3 years from study start date
The incidence of PPROM, defined as rupture of the amniotic sac after FLP surgery and before 37 completed weeks of pregnancy.
When the last (20th) participant reaches delivery, a little more than 3 years from study start date
The rate of placental abruption
Time Frame: When the last (20th) participant reaches delivery, a little more than 3 years from study start date
The rate of separation of the placenta from the uterine wall after FLP surgery and before delivery.
When the last (20th) participant reaches delivery, a little more than 3 years from study start date
The rate of chorioamnionitis
Time Frame: When the last (20th) participant reaches delivery, a little more than 3 years from study start date
The rate of infection of the fetal membranes and amniotic fluid after FLP surgery and before delivery.
When the last (20th) participant reaches delivery, a little more than 3 years from study start date
The rate of chorioamniotic separation
Time Frame: When the last (20th) participant reaches delivery, a little more than 3 years from study start date
The rate of separation of the amniotic and chorionic membranes after FLP surgery and before delivery.
When the last (20th) participant reaches delivery, a little more than 3 years from study start date
Interval from procedure to delivery
Time Frame: When the last (20th) participant reaches delivery, a little more than 3 years from study start date
The length of time from FLP surgery to delivery will be recorded in weeks and days.
When the last (20th) participant reaches delivery, a little more than 3 years from study start date
The rate of fetal growth restriction
Time Frame: When the last (20th) participant reaches delivery, a little more than 3 years from study start date
The rate of fetal growth restriction, defined as an estimated fetal weight or abdominal circumference below the 10th percentile for gestational age, at any time after FLP surgery up to delivery.
When the last (20th) participant reaches delivery, a little more than 3 years from study start date
Fetal brain structure
Time Frame: Two weeks after the last (20th) participant undergoes FLP surgery, about 3 years from study start date
Normal or abnormal fetal brain structure will be assessed by MRI 2 weeks after surgery.
Two weeks after the last (20th) participant undergoes FLP surgery, about 3 years from study start date
The rate of NICU admission
Time Frame: When the last (20th) participant reaches delivery, a little more than 3 years from study start date
The rate of NICU admission after birth will be recorded
When the last (20th) participant reaches delivery, a little more than 3 years from study start date
NICU length of stay
Time Frame: When the last baby is discharged from the NICU, a little more than 3 years from study start date
The number of days that the baby spends in the NICU after birth.
When the last baby is discharged from the NICU, a little more than 3 years from study start date
Short term neonatal morbidity
Time Frame: When the last baby is discharged from the hospital, a little more than 3 years from study start date
The rate of short term morbidity during the first 30 days of life or until hospital discharge, whichever is latest. Short-term morbidity includes neurological problems, gastrointestinal problems, respiratory problems, infections, and other problems associated with prematurity including but not limited to: necrotizing enterocolitis, bronchopulmonary dysplasia, respiratory distress syndrome, neonatal sepsis, neonatal intensive care unit admission and need for extracorporeal membrane oxygenation (ECMO).
When the last baby is discharged from the hospital, a little more than 3 years from study start date
Neonatal survival
Time Frame: When the last baby is discharged from the hospital, a little more than 3 years from study start date
The rate of neonates surviving to 30 days of age, or hospital discharge, whichever is latest.
When the last baby is discharged from the hospital, a little more than 3 years from study start date
Maternal mental health score
Time Frame: Two weeks after the last (20th) participant undergoes FLP surgery, about 3 years from study start date
The Postpartum Depression Screening Scale (PDSS) - Antenatal Version will be used to assess and compare the levels of depression and anxiety before and after FLP surgery. This assessment will be given once before surgery, and once again 4-8 weeks later (at least 2 weeks after surgery).
Two weeks after the last (20th) participant undergoes FLP surgery, about 3 years from study start date
Postnatal examination of the placenta
Time Frame: When the last (20th) participant reaches delivery, a little more than 3 years from study start date
The placenta will be examined for disrupted or ruptured vessels after dye staining. Secondary changes in the accessory lobe will also be checked, which are features resulting from cessation of blood supply due to prior ablation. These could include fibrin deposition, evidence of hypoxia in the chorionic villi, eventual necrosis, and parenchymal atrophy
When the last (20th) participant reaches delivery, a little more than 3 years from study start date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Investigators

  • Principal Investigator: Alireza Shamshirsaz, MD, Director, Maternal Fetal Care Center; Chief, Division of Fetal Medicine and Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

February 26, 2024

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Actual)

March 4, 2024

Study Record Updates

Last Update Posted (Actual)

September 26, 2024

Last Update Submitted That Met QC Criteria

September 24, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-P00044498

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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