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

Primary Purpose

Placenta Accreta

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Study group: lower segment resection with ligation of the anterior division of the internal iliac artery
Control group: lower segment resection without ligation of the anterior division of the internal iliac artery
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Placenta Accreta

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Study group

Control group

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Amount of blood loss intra-operative
Amount of blood loss intra-operative
Amount of blood loss 24 hours post-operative
Amount of blood loss 24 hours post-operative

Secondary Outcome Measures

Operative time
duration of the surgery
Number of blood units transfused
Number of blood units transfused within 24 hours after surgery

Full Information

First Posted
July 3, 2022
Last Updated
July 27, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05471102
Brief Title
Ligation of Anterior Internal Iliac Artery With Conservative Management of Partial or Focal Placenta Accreta Spectrum
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 3, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Accreta

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Name(s)
Study group: lower segment resection with ligation of the anterior division of the internal iliac artery
Intervention Description
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
Intervention Name(s)
Control group: lower segment resection without ligation of the anterior division of the internal iliac artery
Intervention Description
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 Outcome Measure Information:
Title
Amount of blood loss intra-operative
Description
Amount of blood loss intra-operative
Time Frame
during operation
Title
Amount of blood loss 24 hours post-operative
Description
Amount of blood loss 24 hours post-operative
Time Frame
24 hours post-operative
Secondary Outcome Measure Information:
Title
Operative time
Description
duration of the surgery
Time Frame
during operation
Title
Number of blood units transfused
Description
Number of blood units transfused within 24 hours after surgery
Time Frame
within 24 hours after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
amr essam
Phone
01004365349
Email
amro_394@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
abdalla mousa
Phone
01277664430
Email
dr_abdallamousa@yahoo.com
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
amr essam
Phone
01004365349
Email
amro_394@hotmail.com

12. IPD Sharing Statement

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

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