Laser Surgery for Vasa Previa (FLUMEN Trial)

N/A

Waitlist Available

Led By Alireza Shamshirsaz

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up when the last (20th) participant undergoes flp surgery, about 3 years from study start date.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the safety and effectiveness of a fetal surgery called fetoscopic laser photocoagulation (FLP) for the treatment of vasa previa (VP), a dangerous pregnancy complication

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of FLP may include complications from surgery such as bleeding or infection, adverse reactions affecting the mother or fetus due to the procedure itself, but exact side effects are not detailed in this summary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ when the last (20th) participant undergoes flp surgery, about 3 years from study start date.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~when the last (20th) participant undergoes flp surgery, about 3 years from study start date.

This trial's timeline: 3 weeks for screening, Varies for treatment, and when the last (20th) participant undergoes flp surgery, about 3 years from study start date. for reporting.