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This study aims to evaluate the efficacy and safety of bilateral internal iliac artery balloon occlusion in the management of the placenta accreta spectrum.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional management | Active Comparator | Patients will be subjected to conventional management for placenta accreta spectrum. |
|
| Bilateral internal iliac artery balloon occlusion | Experimental | Patients will be subjected to bilateral internal iliac artery balloon occlusion for placenta accreta spectrum. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional management | Procedure | Patients will be subjected to conventional management for placenta accreta spectrum. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amount of intraoperative blood loss | The amount of intraoperative blood loss will be calculated with reference to the contents of the suction apparatus and to weight of the surgical pads and the hemoglobin concentration difference, immediate preoperative (the morning of cesarean delivery) and postoperative (immediately after cesarean delivery) hemoglobin levels. | Intraoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Operation time | Operation time will be recorded from start till end of surgery. | From the start till the end of surgery |
| Number of blood products units transfused | Number of blood products units transfused will be recorded. |
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Inclusion Criteria:
Exclusion Criteria:
Women with placenta accreta spectrum
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Tanta | El-Gharbia | 31527 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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| Bilateral internal iliac artery balloon occlusion | Procedure | Patients will be subjected to bilateral internal iliac artery balloon occlusion for placenta accreta spectrum. |
|
| 24 hours postoperatively |
| Hospitalization length | Hospitalization length will be recorded from admission till discharge from hospital. | 28 days postoperatively |
| Incidence of hysterectomy | Incidence of hysterectomy will be recorded. | 24 hours postoperatively |
| Intensive Care Unit (ICU) admission rate | Intensive Care Unit (ICU) admission rate will be recorded. | 24 hours postoperatively |
| Intraoperative complications | Intraoperative complications such as bladder injury, ureteric ligature, and uterine atony will be recorded. | Intraoperatively |
| ID | Term |
|---|---|
| D010921 | Placenta Accreta |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D010922 | Placenta Diseases |
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