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

NCT ID: NCT05471102

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-03
• Study Completion Date: 2024-01-31

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

Conditions

Placenta Accreta

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Study group

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.

Group Type: ACTIVE_COMPARATOR

Study group: lower segment resection with ligation of the anterior division of the internal iliac artery

Intervention Type: PROCEDURE

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.

Control group

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).

Group Type: PLACEBO_COMPARATOR

Control group: lower segment resection without ligation of the anterior division of the internal iliac artery

Intervention Type: PROCEDURE

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).

Interventions

Study group: lower segment resection with ligation of the anterior division of the internal iliac artery

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.

Intervention Type: PROCEDURE

Control group: lower segment resection without ligation of the anterior division of the internal iliac artery

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).

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Abdalla Mousa

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MS-38-2022

Identifier Type: -

Identifier Source: org_study_id