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

Not Applicable

• Conditions: Placenta Accreta

• Registration Number: NCT05471102
• Lead Sponsor: Cairo University

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

Study Timeline

• Status Verified: 2022-07
• Study Start: 2022-07-03
• Study First Submitted: 2022-07-03
• Study First Submitted QC: 2022-07-21
• Study First Posted: 2022-07-22
• Last Update Submitted: 2022-07-27
• Last Update Posted: 2022-08-01
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Amount of blood loss 24 hours post-operative	24 hours post-operative	Amount of blood loss 24 hours post-operative
Amount of blood loss intra-operative	during operation	Amount of blood loss intra-operative

Secondary Outcome Measures

Name	Time	Method
Operative time	during operation	duration of the surgery
Number of blood units transfused	within 24 hours after surgery	Number of blood units transfused within 24 hours after surgery

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt