protocolSection identificationModule nctId: NCT06290232, orgStudyIdInfo id: IRB-P00044498, briefTitle: Fetoscopic Laser Photocoagulation in Management of Vasa Previa, acronym: FLUMEN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Boston Children's Hospital, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Vasa Previa, conditions: Pregnancy Complications, conditions: Maternal; Procedure, conditions: In Utero Procedure Affecting Fetus or Newborn, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Fetoscopic Laser Photocoagulation, outcomesModule primaryOutcomes measure: Mode of delivery, primaryOutcomes measure: Gestational age at delivery, primaryOutcomes measure: Successful visualization and mapping of vasa previa, primaryOutcomes measure: The rate of successful coagulation of the vasa previa - intraoperative imaging, primaryOutcomes measure: The rate of successful coagulation of the vasa previa - postoperative imaging, primaryOutcomes measure: The rate of successful coagulation of the vasa previa - pathology, primaryOutcomes measure: Placental function, secondaryOutcomes measure: GA at hospital admission, secondaryOutcomes measure: Duration of hospital stay, secondaryOutcomes measure: Cause for hospital admission, secondaryOutcomes measure: The rate of spontaneous preterm labor, secondaryOutcomes measure: The rate of preterm premature rupture of membranes (PPROM), secondaryOutcomes measure: The rate of placental abruption, secondaryOutcomes measure: The rate of chorioamnionitis, secondaryOutcomes measure: The rate of chorioamniotic separation, secondaryOutcomes measure: Interval from procedure to delivery, secondaryOutcomes measure: The rate of fetal growth restriction, secondaryOutcomes measure: Fetal brain structure, secondaryOutcomes measure: The rate of NICU admission, secondaryOutcomes measure: NICU length of stay, secondaryOutcomes measure: Short term neonatal morbidity, secondaryOutcomes measure: Neonatal survival, secondaryOutcomes measure: Maternal mental health score, secondaryOutcomes measure: Postnatal examination of the placenta, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Boston Children's Hospital, city: Boston, state: Massachusetts, zip: 02115, country: United States, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False