Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-01-15 @ 3:05 PM
Study NCT ID:
NCT05471102
Status:
COMPLETED
Last Update Posted:
2025-07-30
First Post:
2022-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ligation of Anterior Internal Iliac Artery With Conservative Management of Partial or Focal Placenta Accreta Spectrum
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Role of Ligation of the Anterior Division of the Internal Iliac Artery in Conservative Management of Patients Diagnosed With Partial or Focal Placenta Accreta Spectrum
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The patients will be divided into 2 groups:
Group (A) - Study group: Cases managed by lower segment resection with ligation of the anterior division of the internal iliac artery
Group (B) - Control group: Cases managed by lower segment resection without ligation of the anterior division of the internal iliac artery
The following operative details will be recorded:
* Estimation of total blood loss
* Pre and 24-h post-operative hemoglobin (g/dl).
* The need for blood transfusion and its amount intra or postoperative will be recorded
* Operative time and postoperative hospital stay will be recorded.
* Close post-operative monitoring of the patients' vital signs, drain output, and urine output
* Presence or absence of intraoperative complications; bladder, ureteric, bowel, or vascular injuries will be recorded.
* Monitoring for postoperative morbidities
Group (A) - Study group: Cases managed by lower segment resection with ligation of the anterior division of the internal iliac artery
Group (B) - Control group: Cases managed by lower segment resection without ligation of the anterior division of the internal iliac artery
The following operative details will be recorded:
* Estimation of total blood loss
* Pre and 24-h post-operative hemoglobin (g/dl).
* The need for blood transfusion and its amount intra or postoperative will be recorded
* Operative time and postoperative hospital stay will be recorded.
* Close post-operative monitoring of the patients' vital signs, drain output, and urine output
* Presence or absence of intraoperative complications; bladder, ureteric, bowel, or vascular injuries will be recorded.
* Monitoring for postoperative morbidities
Detailed Description:
The patients will be divided into 2 groups:
Group (A) - Study group: Cases managed by uterine lower segment resection with ligation of the anterior division of the internal iliac artery (4 cm distal to the bifurcation of the common iliac artery).
Group (B) - Control group: Cases managed by uterine lower segment resection without ligation of the anterior division of the internal iliac artery.
In both groups, bilateral uterine artery ligation at 2 levels will be done; bilateral ligation at a level below the lower most placental part, followed by bilateral uterine artery ligation at the level of the hysterotomy incision.
The following operative details will be recorded:
* Estimation of total blood loss
* Pre and 24-h post-operative hemoglobin (g/dl).
* The need for blood transfusion and its amount intra or post-operative will be recorded
* Operative time and postoperative hospital stay will be recorded.
* Close post-operative monitoring of the patients' vital signs, drain output, and urine output
* Presence or absence of intraoperative complications; bladder, ureteric, bowel, or vascular injuries will be recorded.
* Monitoring for postoperative morbidities
Group (A) - Study group: Cases managed by uterine lower segment resection with ligation of the anterior division of the internal iliac artery (4 cm distal to the bifurcation of the common iliac artery).
Group (B) - Control group: Cases managed by uterine lower segment resection without ligation of the anterior division of the internal iliac artery.
In both groups, bilateral uterine artery ligation at 2 levels will be done; bilateral ligation at a level below the lower most placental part, followed by bilateral uterine artery ligation at the level of the hysterotomy incision.
The following operative details will be recorded:
* Estimation of total blood loss
* Pre and 24-h post-operative hemoglobin (g/dl).
* The need for blood transfusion and its amount intra or post-operative will be recorded
* Operative time and postoperative hospital stay will be recorded.
* Close post-operative monitoring of the patients' vital signs, drain output, and urine output
* Presence or absence of intraoperative complications; bladder, ureteric, bowel, or vascular injuries will be recorded.
* Monitoring for postoperative morbidities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: