Ligation of Anterior Internal Iliac Artery With Conservative Management of Partial or Focal Placenta Accreta Spectrum

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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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

Conditions
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Placenta Accreta

Intervention / Treatment
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* Procedure: Study group: lower segment resection with ligation of the anterior division of the internal iliac artery
* Procedure: Control group: lower segment resection without ligation of the anterior division of the internal iliac artery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 20-40 years old. Pregnancy of singleton living fetus. Previous one or more cesarean sections. Gestational age: > 36 weeks. Elective termination of pregnancy. Cases not requiring preoperative blood transfusion. Cases with focal area of placental adherence or invasion leaving sufficient healthy myometrial tissue for uterine repair and preservation. The following ultrasound markers such as loss of clear retroplacental translucency, myometrial thinning, abnormal lacunae, irregular bladder wall, utero-vesical hypervascularity. Exclusion Criteria: Multifetal pregnancy. More than four previous sections. Emergency termination of pregnancy due to antepartum hemorrhage, placental separation or rupture uterus. Intrauterine fetal death. Women with history of any medical disorder with pregnancy eg. Gestational diabetes and hypertension. Premature rupture of membranes. Cases misdiagnosed as placenta accreta by ultrasound preoperatively, and spontaneous full placental separation occurred intraoperative. will be excluded before randomization Cases with PAS with total invasion involving all placental lobules. Cases who will be managed by cesarean hysterectomy due to uncontrolled intraoperative bleeding.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study group<br>Cases managed by uterine lower segment resection with ligation ((suturing)) of the anterior division of the internal iliac artery (4 cm distal to the bifurcation of the common iliac artery); in addition to the bilateral uterine artery ligation at 2 levels; bilateral ligation at a level below the lower most placental part followed by bilateral uterine artery ligation at the level of the hysterotomy incision. | Procedure: Study group: lower segment resection with ligation of the anterior division of the internal iliac artery<br>* Cases managed by uterine lower segment resection with ligation ((suturing)) of the anterior division of the internal iliac artery (4 cm distal to the bifurcation of the common iliac artery); in addition to the bilateral uterine artery ligation at 2 levels; bilateral ligation at a level below the lower most placental part followed by bilateral uterine artery ligation at the level of the hysterotomy incision.<br>|
| Placebo Comparator: Control group<br>Cases managed by uterine lower segment resection without ligation of the anterior division of the internal iliac artery. (i.e., only bilateral ligation at a level below the lower most placental part followed by bilateral uterine artery ligation at the level of the hysterotomy incision). | Procedure: Control group: lower segment resection without ligation of the anterior division of the internal iliac artery<br>* Cases managed by uterine lower segment resection without ligation of the anterior division of the internal iliac artery. (i.e., only bilateral ligation at a level below the lower most placental part followed by bilateral uterine artery ligation at the level of the hysterotomy incision).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of blood loss intra-operative | Amount of blood loss intra-operative | during operation | 
| Amount of blood loss 24 hours post-operative | Amount of blood loss 24 hours post-operative | 24 hours post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | duration of the surgery | during operation | 
| Number of blood units transfused | Number of blood units transfused within 24 hours after surgery | within 24 hours after surgery |