- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05471102
Ligation of Anterior Internal Iliac Artery With Conservative Management of Partial or Focal Placenta Accreta Spectrum
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
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
Study Overview
Status
Conditions
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Cairo, Egypt
- Cairo University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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.
|
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.
|
|
Placebo Comparator: 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).
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Amount of blood loss intra-operative
Time Frame: during operation
|
Amount of blood loss intra-operative
|
during operation
|
|
Amount of blood loss 24 hours post-operative
Time Frame: 24 hours post-operative
|
Amount of blood loss 24 hours post-operative
|
24 hours post-operative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Operative time
Time Frame: during operation
|
duration of the surgery
|
during operation
|
|
Number of blood units transfused
Time Frame: within 24 hours after surgery
|
Number of blood units transfused within 24 hours after surgery
|
within 24 hours after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS-38-2022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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