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

NCT05471102 | Completed

• 1 other identifier: MS-38-2022
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Conditions

Placenta Accreta

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Operative time

  during operation

• Number of blood units transfused

  within 24 hours after surgery

Study Arms (2)

Study group

ACTIVE COMPARATOR

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

Control group

PLACEBO COMPARATOR

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

Interventions

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

Study group

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

Control group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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".

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 3, 2022
• First Posted: July 22, 2022
• Study Start: July 3, 2022
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

EG (1)