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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test the safety and effectiveness of fetoscopic laser photocoagulation (FLP) for treating vasa previa, a pregnancy complication where fetal blood vessels grow over the womb's entrance. In such cases, natural birth can be extremely dangerous for the baby, often leading to severe blood loss. FLP surgery uses a tiny telescope and laser to seal off these risky blood vessels, potentially allowing for a safer vaginal delivery instead of a C-section. The trial seeks pregnant individuals diagnosed with type II vasa previa who meet specific criteria related to their pregnancy and condition. As an unphased trial, this study offers participants the opportunity to contribute to pioneering research that could improve outcomes for future pregnancies.

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 prior data suggests that this surgery is safe for treating vasa previa?

Research shows that fetoscopic laser photocoagulation (FLP) is a promising treatment for vasa previa, a serious pregnancy condition. Studies report a high success rate of 98.1% for the procedure, with no major complications for mothers. Most procedures succeed without causing significant issues for the mother. Additionally, the newborn survival rate is 100%, which is very reassuring. Early evidence suggests that FLP is generally well-tolerated, although researchers are still specifically studying it for vasa previa. While these findings are encouraging, more research is needed to confirm its long-term safety and effectiveness for this condition. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Fetoscopic Laser Photocoagulation is unique because it directly targets the abnormal blood vessels involved in type II vasa previa using a laser. Unlike traditional management, which often involves hospitalization and early delivery to prevent vessel rupture, this approach aims to treat the condition in utero, potentially reducing risks associated with premature birth. Researchers are excited about this treatment because it offers a minimally invasive method that could improve outcomes for both the mother and the baby by addressing the root issue before complications arise.

What evidence suggests that fetoscopic laser photocoagulation might be an effective treatment for vasa previa?

Research has shown that a procedure called fetoscopic laser photocoagulation (FLP), which participants in this trial will undergo, may help treat vasa previa (VP). In one study, FLP succeeded 98.1% of the time and ensured all babies survived. Additionally, 50% of those treated were able to have a vaginal delivery, which is significant because VP often requires a C-section. The procedure uses a tiny telescope and laser to close off risky blood vessels in the womb. While FLP has worked well for similar conditions, it hasn't been specifically proven for VP yet. However, early results are promising for reducing risks and avoiding long hospital stays. ^{2 4 5 6 7}

Who Is on the Research Team?

Alireza Shamshirsaz, MD

Principal Investigator

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

Are You a Good Fit for This Trial?

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

My pregnancy has a specific type of vasa previa.

Pregnant patient with singleton pregnancy

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39217452/

Fetoscopic laser photocoagulation: a medically reasonable ...

Fetoscopic laser photocoagulation using a single-port fetoscope has emerged as a potential therapeutic option for patients with types II and III vasa previa.

2.

obgyn.onlinelibrary.wiley.com

obgyn.onlinelibrary.wiley.com/doi/10.1002/pd.6897?af=R

Fetoscopic Laser Ablation of Type II Vasa Previa—Case ...

FLA was associated with a 98.1% technical success rate, 50% vaginal delivery rate, and 100% neonatal survival, with no major maternal ...

3.

ajog.org

ajog.org/article/S0002-9378(23)00621-X/abstract

Third-trimester fetoscopic ablation therapy for types II and ...

This study aimed to assess feasibility and outcomes of types II and III vasa previa patients treated via fetoscopic laser ablation in the third trimester.

4.

contemporaryobgyn.net

contemporaryobgyn.net/view/laser-ablation-for-vasa-previa-shows-promising-results

Laser ablation for vasa previa shows promising results

The study evaluated outcomes from fetoscopic laser ablation at 31 to 33 weeks' gestation for types 2 and 3 vasa previa, showing successful ...

5.

clinicaltrial.be

clinicaltrial.be/en/details/427694?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Fetoscopic Laser Photocoagulation in Management of ...

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 ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40271544/

Fetoscopic Laser Surgery for Vasa Previa: Feasibility, ...

This review examines vasa previa management, the feasibility of laser therapy, and its risks. While early data are promising, further studies, ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S1521693425000987

Vasa Previa: A Condition with Diverse Management ...

Fetoscopic laser photocoagulation (FLP) is an investigational, minimally invasive intervention for selected cases of types II and III vasa ...