Fetoscopic Laser Photocoagulation in Management of Vasa Previa

Launched by BOSTON CHILDREN'S HOSPITAL · Feb 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a special surgery called fetoscopic laser photocoagulation (FLP) to help treat a pregnancy condition known as vasa previa. Vasa previa occurs when blood vessels from the fetus grow over the opening of the womb, which can be very dangerous for the baby during delivery. If these vessels burst, it can lead to severe bleeding. Currently, women with vasa previa are often closely monitored and may need to be hospitalized in the later stages of pregnancy. The FLP procedure aims to seal off these vulnerable blood vessels using a tiny camera and laser, potentially reducing risks and allowing for a safer delivery, possibly even vaginal delivery instead of a C-section.

To participate in this trial, women must be pregnant with a single baby and have a confirmed diagnosis of type II vasa previa. They need to be eligible for the surgery between 30 to 33 weeks of pregnancy. Some key factors that would make someone eligible include being able to undergo anesthesia and providing consent for the procedure. However, there are certain conditions that would exclude someone from participating, such as having multiple pregnancies or other serious health issues. Participants can expect to undergo this minimally invasive surgery and will be monitored closely for safety and effectiveness. This research could provide new insights into better managing vasa previa and improving outcomes for both mothers and babies.

Gender

FEMALE

Eligibility criteria

• 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