Laser Surgery for Vasa Previa

(FLUMEN Trial)

Overseen By Ali Javinani, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Disqualifiers: Multiple pregnancy, Fetal growth restriction, Preeclampsia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have an allergy or previous adverse reaction to certain medications with no available alternative, you may be excluded from the trial.

What data supports the effectiveness of the treatment Fetoscopic Laser Photocoagulation for Vasa Previa?

Research shows that fetoscopic laser photocoagulation for type II vasa previa can help avoid long hospital stays, early delivery, and cesarean sections, allowing for the possibility of a normal vaginal delivery at term. This treatment has been successful in reducing risks associated with vasa previa, such as fetal death, by addressing the condition directly in the womb. ^{1 2 3 4 5}

Is laser surgery for vasa previa safe for humans?

Fetoscopic laser surgery for vasa previa has been used successfully in humans, allowing for term vaginal delivery without complications in some cases. However, there are potential risks associated with the procedure, which can be reduced by timing the surgery appropriately. ^{1 3 4 5 6}

How does the treatment Fetoscopic Laser Photocoagulation for Vasa Previa differ from other treatments?

Fetoscopic Laser Photocoagulation is unique because it uses a laser to seal abnormal blood vessels in the placenta, which is a minimally invasive approach compared to traditional surgical methods. This technique is specifically designed to address the unique challenges of Vasa Previa, where fetal blood vessels are at risk of rupture, and there are no standard treatments for this condition. ^{7 8 9 10 11}

What is the purpose of this trial?

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.

Research Team

Alireza Shamshirsaz, MD

Principal Investigator

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

Eligibility Criteria

This trial is for pregnant individuals diagnosed with vasa previa, a condition where fetal blood vessels cover the womb's entrance. Participants should be in their third trimester and have not undergone any prior treatment for vasa previa. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

Able to undergo intervention during a specific gestational age range

Pregnant patient with singleton pregnancy

Confirmed diagnosis of vasa previa meeting specific criteria

Exclusion Criteria

My unborn baby is at high risk for bleeding disorders.

Gestational age at referral higher than 32w6d

My condition is diagnosed as vasa previa type I or III.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo fetoscopic laser photocoagulation surgery to treat vasa previa

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after FLP surgery, including assessments of placental function and fetal brain structure

2 weeks

2 visits (in-person)

Delivery and Postnatal Follow-up

Participants are monitored until delivery, and neonatal outcomes such as NICU admission and neonatal survival are recorded

Up to delivery (approximately 3 years from study start)

Treatment Details

Interventions

• Fetoscopic Laser Photocoagulation

Trial Overview The study tests fetoscopic laser photocoagulation (FLP), a minimally invasive surgery aiming to correct abnormal fetal blood vessels in pregnancies complicated by vasa previa. The goal is to reduce severe bleeding risks, potentially avoid long hospital stays before delivery, and enable vaginal birth.

Participant Groups

Group I: Fetoscopic Laser Photocoagulation Surgery Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Fetoscopic Laser Ablation Therapy for Type II Vasa Previa. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Fetoscopic Laser Ablation of Type II Vasa Previa: A Cost Benefit Analysis. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Third trimester fetoscopic laser ablation of type II vasa previa. [2016]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Term vaginal delivery following fetoscopic laser photocoagulation of type II vasa previa. [2014]

5. United States pubmed.ncbi.nlm.nih.gov

Third-trimester fetoscopic ablation therapy for types II and III vasa previa. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Maternal complications of fetoscopic laser photocoagulation (FLP) for treatment of twin-twin transfusion syndrome (TTTS). [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic Lateral Suspension: Benefits of a Cross-shaped Mesh to Treat Difficult Vaginal Vault Prolapse. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Feasibility and outcome of vaginal paravaginal repair using the Capio suture-capturing device. [2021]

9. Ukraine pubmed.ncbi.nlm.nih.gov

[High resection of the left testicular vein and ligation of the internal iliac artery using a retroperitoneoscope]. [2014]

10. United States pubmed.ncbi.nlm.nih.gov

Vaginoscopic resection of vaginal septum. [2022]

11. Australia pubmed.ncbi.nlm.nih.gov

Successful vaginoscopic excision of the vaginal septum in a virgin girl of obstructed hemivagina and ipsilateral renal anomaly: Case report and review of literature. [2023]