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

Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06356493
• Other study ID #: OBIIA CMNT
• Status: Completed
• Start date: January 2, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2024
• Source: Tunis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications
• Hemorrhage
• Placenta Accreta
• Placenta Accreta Spectrum

Intervention

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.
• 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.

Locations

Country	Name	City	State
Tunisia	Haithem Aloui	Manouba	Nabeul
Tunisia	Haithem Aloui	Tunis	Nabeul

Sponsors (1)

Lead Sponsor	Collaborator
Tunis University

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	calculated blood loss	The blood losses were calculated by weighing the surgical drapes and compresses and quantifying the aspirated bleeding	peroperatively
Primary	Transfusion peroperatively	peroperatively	First 24 hours]
Primary	Duration of surgery	MINUTES	peroperatively
Primary	Postoperative hospital stay	DAYS	up to 40 days postpartum
Primary	Postoperative transfer to the intensive care unit	NUMBER	up to 40 days postpartum
Secondary	Morbidity	surgical site infection, bladder injury, need for surgical revision, and pulmonary embolism	time from surgery up to 30 days postoperative