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

Prophylactic Occlusion Balloons of Both Internal Iliac Arteries in Caesarean Hysterectomy for Placenta Accreta Spectrum Disorder Reduces Blood Loss: a Retrospective Comparative Study

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.

Study Overview

• Status: Completed
• Conditions: Hemorrhage; Cesarean Section Complications; Placenta Accreta Spectrum
• Intervention / Treatment: Procedure: caesarean hysterectomy without 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

Detailed Description

Study population:

In the study, the population was divided into two groups:

Group1: Patients treated by 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.

Service Protocol:

All patients received dexamethasone for foetal lung maturation. 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.

General anaesthesia was preferred. Blood loss was estimated by weighing surgical sponges and drapes and quantifying aspirated blood.

Initially, a JJ stent was inserted for both groups to limit urinary tract injuries. 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 foetus was delivered. Inflation of the occlusion balloons of both internal iliac arteries was performed simultaneously with extraction by the radiologist. 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.

the surgeon proceeded with the remaining steps of hysterectomy. The radiologist deflated the balloons at the end of the hysterectomy. The inflation of the OBIIA did not exceed 60 minutes. Haemostasis was verified, and an intraperitoneal drainage system was installed. A video was developed summarizing the procedure in Group 2.

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• Tunisia
  • Nabeul
    • Manouba, Nabeul, Tunisia, 2010
      • Haithem Aloui
    • Tunis, Nabeul, Tunisia, 2010
      • Haithem Aloui

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity	surgical site infection, bladder injury, need for surgical revision, and pulmonary embolism	time from surgery up to 30 days postoperative

Collaborators and Investigators

• Sponsor: Tunis University
• Investigators: Principal Investigator: Haithem Aloui, Doctor, Tunis University Manar

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: March 30, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: haemorrhage; Placenta accreta spectrum disorder; caesarean hysterectomy; occlusion balloons; internal iliac artery
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hemorrhage; Placenta Accreta
• Other Study ID Numbers: OBIIA CMNT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No