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

Placenta Accreta Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05471102
• Other study ID #: MS-38-2022
• Status: Recruiting
• Phase: N/A
• Start date: July 3, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: July 2022
• Source: Cairo University
• Contact: amr essam
• Phone: 01004365349
• Email: amro_394[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Placenta Accreta

Intervention

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

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of blood loss intra-operative	Amount of blood loss intra-operative	during operation
Primary	Amount of blood loss 24 hours post-operative	Amount of blood loss 24 hours post-operative	24 hours post-operative
Secondary	Operative time	duration of the surgery	during operation
Secondary	Number of blood units transfused	Number of blood units transfused within 24 hours after surgery	within 24 hours after surgery