Clinical trial NCT05471102: Ligation of Anterior Internal Iliac Artery With Conservative Management of Partial or Focal Placenta Accreta Spectrum
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Placenta Accreta
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Amount of blood loss intra-operative
timeFrame: during operation
measure: Amount of blood loss 24 hours post-operative
timeFrame: 24 hours post-operative
Secondary outcomes:
measure: Operative time
timeFrame: during operation
measure: Number of blood units transfused
timeFrame: within 24 hours after surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: