Stopped: The Primary Investigator for this study has departed this institution. Other investigators at this institution were not interested in proceeding with this 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.
Age range
18 Years – 55 Years
Sex
FEMALE
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Mode of delivery
Timeframe: When the last (20th) participant reaches delivery, a little more than 3 years from study start date
Gestational age at delivery
Timeframe: When the last (20th) participant reaches delivery, a little more than 3 years from study start date
Successful visualization and mapping of vasa previa
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: When the last (20th) participant reaches delivery, a little more than 3 years from study start date
Placental function
Timeframe: Two weeks after the last (20th) participant undergoes FLP surgery, about 3 years from study start date.