Prophylactic Occlusion Balloons of Both Internal Iliac Arteries in Caesarean Hysterectomy for PASD

NCT06356493 | Completed

• 1 other identifier: OBIIA CMNT
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 2

Brief Summary

The placenta accreta spectrum is a heterogeneous disorder due to abnormal placental invasion into the uterine wall putting at risk the lives of the patients by causing a massive hemorrhage. Its incidence is increasing due to the rise of the cesarean section. The management of this spectrum is multidisciplinary but not yet codified. Hysterectomy-caesarean, though hemostatic surgery, remains the standard Gold. Several adjuvant treatments have emerged in recent years to minimize the risk of bleeding and morbidity of these disorders including the internal-iliac prophylactic occlusion balloons. The aim of the study is to demonstrate the effect of prophylactic occlusion balloons in both uterine iliac arteries in the management of placental accreta spectrum disorders.

Conditions

Hemorrhage; Placenta Accreta Spectrum; Cesarean Section Complications

Keywords

haemorrhage; Placenta accreta spectrum disorder; caesarean hysterectomy; occlusion balloons; internal iliac artery

Outcome Measures

Primary Outcomes (5)

• calculated blood loss

  The blood losses were calculated by weighing the surgical drapes and compresses and quantifying the aspirated bleeding

  peroperatively

• Transfusion peroperatively

  peroperatively

  First 24 hours]

• Duration of surgery

  MINUTES

  peroperatively

• Postoperative hospital stay

  DAYS

  up to 40 days postpartum

• Postoperative transfer to the intensive care unit

  NUMBER

  up to 40 days postpartum

Secondary Outcomes (1)

• Morbidity

  time from surgery up to 30 days postoperative

Study Arms (2)

Group1

Patients treated by caesarean hysterectomy without prior placement of prophylactic occlusion balloons of both internal iliac arteries

Procedure: caesarean hysterectomy without prior placement of prophylactic occlusion balloons of both internal iliac arteries

Group2:

Patients treated by caesarean hysterectomy with prior placement of prophylactic occlusion balloons of both internal iliac arteries

Procedure: caesarean hysterectomy with prior placement of prophylactic occlusion balloons of both internal iliac arteries

Interventions

caesarean hysterectomy with prior placement of prophylactic occlusion balloons of both internal iliac arteries PROCEDURE

Preoperative placement of prophylactic occlusion balloons of both internal iliac arteries (OBIIA) was performed at radiology department. Access to the internal iliac arteries was achieved by retrograde transcutaneous introduction of hydrophilic sheath kits of 8.5 mm under fluoroscopic guidance from both femoral arteries. Once in the lumens of the two internal iliac arteries, the radiologist inflated the balloons until blood flow ceased. The pressure at which occlusion of both internal iliac arteries was achieved was recorded for subsequent replication in the operating room. The radiologist secured the two kits to the skin and applied a compressive dressing. The patient was then directly transferred to the operating room.

Group2:

caesarean hysterectomy without prior placement of prophylactic occlusion balloons of both internal iliac arteries PROCEDURE

Caesarean hysterectomy was performed through a midline infraumbilical incision. The bladder-uterine peritoneum was dissected, followed by a vertical fundal hysterotomy away from the placenta, and the baby was delivered This was followed by clamping the umbilical cord and closure of the hysterotomy while leaving the placenta in situ without any attempt at traction or delivery and without oxytocin administration. We proceeded with the remaining steps of hysterectomy.

Group1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

We collected 38 patients who were divided into two groups: Group 1 (n=22), Group 2 (n=16).

You may qualify if:

• placenta accreta spectrum disorder (PASD) confirmed by histopathological examination.
• caesarean hysterectomy.

You may not qualify if:

• placenta accreta suspected in MRI fundings but disproved in in histopathological examination.
• conservative treatment of PASD

Sponsors & Collaborators

• Tunis University: lead

Study Sites (2)

Haithem Aloui

Manouba, Nabeul Governorate, 2010, Tunisia

Location

Haithem Aloui

Tunis, Nabeul Governorate, 2010, Tunisia

Location

MeSH Terms

Conditions

Hemorrhage; Placenta Accreta

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Officials

• Haithem Aloui, Doctor

  Tunis University Manar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: university hospital assistant

Study Record Dates

• First Submitted: March 30, 2024
• First Posted: April 10, 2024
• Study Start: January 2, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

TU (2)