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Clinical Trials/NCT05471102
NCT05471102
Completed
Not Applicable

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

Cairo University1 site in 1 country44 target enrollmentJuly 3, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Placenta Accreta
Sponsor
Cairo University
Enrollment
44
Locations
1
Primary Endpoint
Amount of blood loss 24 hours post-operative
Status
Completed
Last Updated
9 months ago

Overview

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

Registry
clinicaltrials.gov
Start Date
July 3, 2022
End Date
January 31, 2024
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Abdalla Mousa

Principal Investigator

Cairo University

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.

Outcomes

Primary Outcomes

Amount of blood loss 24 hours post-operative

Time Frame: 24 hours post-operative

Amount of blood loss 24 hours post-operative

Amount of blood loss intra-operative

Time Frame: during operation

Amount of blood loss intra-operative

Secondary Outcomes

  • Operative time(during operation)
  • Number of blood units transfused(within 24 hours after surgery)

Study Sites (1)

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