An observational study in Hemorrhage, Placenta Accreta Spectrum and Cesarean Section Complications, sponsored by Tunis University. Completed at 2 sites in Tunisia. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-04-10.
Sponsored by Tunis University · Observational
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 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.
147 studies on the registry are indexed under Placenta Accreta; 39 are open to participants now.
This study's enrollment of 38 is below the median of 84 across 79 observational studies indexed under Placenta Accreta.
Browse Placenta Accreta studies →Tunis University is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
We collected 38 patients who were divided into two groups: Group 1 (n=22), Group 2 (n=16).
Exclusion Criteria:
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
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.
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.
calculated blood loss
The blood losses were calculated by weighing the surgical drapes and compresses and quantifying the aspirated bleeding
Time frame: peroperatively
Transfusion peroperatively
peroperatively
Time frame: First 24 hours]
Duration of surgery
MINUTES
Time frame: peroperatively
Postoperative hospital stay
DAYS
Time frame: up to 40 days postpartum
Postoperative transfer to the intensive care unit
NUMBER
Time frame: up to 40 days postpartum
Morbidity
surgical site infection, bladder injury, need for surgical revision, and pulmonary embolism
Time frame: time from surgery up to 30 days postoperative
Plan to share: Undecided
No publications or documents are linked to this record.
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Tunis University