Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562712
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Evaluation of Bilateral Internal Iliac Artery Balloon Occlusion in Placenta Accreta Spectrum Management
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Bilateral Internal Iliac Artery Balloon Occlusion in Placenta Accreta Spectrum Management A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to evaluate the efficacy and safety of bilateral internal iliac artery balloon occlusion in the management of the placenta accreta spectrum
Detailed Description:
Placenta accreta spectrum PAS is abnormal placental adhesion beyond superficial myometrium which includes placenta accreta placenta increta and placenta percreta
However there is a desire to preserve the uterus and fertility so alternatives to hysterectomy are needed Presently attempts to avoid hysterectomy include reducing intraoperative hemorrhage such as uterine compression sutures intrauterine balloon tamponade pelvic artery ligation and spiral suturing of the lower uterine segment Intrauterine balloon tamponade may increase CS scar dehiscence uterine rupture and infection Combined with compression sutures it may induce uterine necrosis
Placement of balloons in the bilateral internal iliac arteries before caesarean section can reduce uterine artery pressure and intraoperative blood loss during balloon inflation thus temporarily blocking the main blood supply of the uterus helping to expose the visual field shortening the operation time during surgery and leading to opportunities for timely adjustments to the operative plan during surgery
However there is a desire to preserve the uterus and fertility so alternatives to hysterectomy are needed Presently attempts to avoid hysterectomy include reducing intraoperative hemorrhage such as uterine compression sutures intrauterine balloon tamponade pelvic artery ligation and spiral suturing of the lower uterine segment Intrauterine balloon tamponade may increase CS scar dehiscence uterine rupture and infection Combined with compression sutures it may induce uterine necrosis
Placement of balloons in the bilateral internal iliac arteries before caesarean section can reduce uterine artery pressure and intraoperative blood loss during balloon inflation thus temporarily blocking the main blood supply of the uterus helping to expose the visual field shortening the operation time during surgery and leading to opportunities for timely adjustments to the operative plan during surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None