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Completed

NCT Number: NCT05471102

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

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

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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).

Primary outcomes

  1. Amount of blood loss intra-operative

    Time frame: during operation

    Amount of blood loss intra-operative

  2. Amount of blood loss 24 hours post-operative

    Time frame: 24 hours post-operative

    Amount of blood loss 24 hours post-operative

Secondary outcomes

  1. Operative time

    Time frame: during operation

    duration of the surgery

  2. Number of blood units transfused

    Time frame: within 24 hours after surgery

    Number of blood units transfused within 24 hours after surgery

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 22, 2022
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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