HemorrhageNCT06356493
Prophylactic Occlusion Balloons of Both Internal Iliac Arteries in Caesarean Hysterectomy for PASD
An observational study of Hemorrhage and Placenta Accreta Spectrum, run by Tunis University at 2 sites in Tunisia.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hemorrhage, Placenta Accreta Spectrum, Cesarean Section Complications
- What is being tested?
- caesarean hysterectomy with prior placement of prophylactic occlusion balloons of both internal iliac arteries and caesarean hysterectomy without prior placement of prophylactic occlusion balloons of both internal iliac arteries
- Type of treatment
- Surgery or procedure
- How many people
- 38 participants
- Where
- 2 sitesTunisia
- Study dates
- 2 Jan 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: We collected 38 patients who were divided into two groups: Group 1 (n=22), Group 2 (n=16).
Who may be able to join
- placenta accreta spectrum disorder (PASD) confirmed by histopathological examination.
- caesarean hysterectomy.
Who cannot join
- placenta accreta suspected in MRI fundings but disproved in in histopathological examination.
- conservative treatment of PASD
Trial locations and contacts
2 sites in 1 country.
Tunisia2 sites
Haithem Aloui
Manouba, Nabeul Governorate, 2010
Haithem Aloui
Tunis, Nabeul Governorate, 2010
About this study
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
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.
Read the 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.
- Being tested
- caesarean hysterectomy with prior placement of prophylactic occlusion balloons of both internal iliac arteries, caesarean hysterectomy without prior placement of prophylactic occlusion balloons of both internal iliac arteries
- Keywords
- haemorrhage, Placenta accreta spectrum disorder, caesarean hysterectomy, occlusion balloons, internal iliac artery
- Medical subject headings
- Hemorrhage, Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caesarean hysterectomy with prior placement of prophylactic occlusion balloons of both internal iliac arteriesProcedure or surgery
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 arteriesProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Patients treated by caesarean hysterectomy without prior placement of prophylactic occlusion balloons of both internal iliac arteries Receives: 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 Receives: Procedure: caesarean hysterectomy with prior placement of prophylactic occlusion balloons of both internal iliac arteries |
What is being measured
The primary outcome is the main question the study is designed to answer.
calculated blood loss
The blood losses were calculated by weighing the surgical drapes and compresses and quantifying the aspirated bleeding
Measured: peroperatively
Transfusion peroperatively
peroperatively
Measured: First 24 hours]
Duration of surgery
MINUTES
Measured: peroperatively
Postoperative hospital stay
DAYS
Measured: up to 40 days postpartum
Postoperative transfer to the intensive care unit
NUMBER
Measured: up to 40 days postpartum
Secondary outcomes (1)
Morbidity
surgical site infection, bladder injury, need for surgical revision, and pulmonary embolism
Measured: time from surgery up to 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start2 Jan 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tunis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haithem Aloui, Tunis University
- Investigators
- Haithem Aloui, Doctor, Principal investigator, Tunis University Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356493
- Sponsor's protocol ID
- OBIIA CMNT
- Status last verified
- Apr 2024
- First submitted
- 30 Mar 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06356493
- Acronym / sponsor ID
- OBIIA CMNT
- Keywords
- haemorrhage, Placenta accreta spectrum disorder, caesarean hysterectomy, occlusion balloons, internal iliac artery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Tunis UniversityUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1 | – | Procedure: caesarean hysterectomy without prior placement of prophylactic occlusion balloons of both internal iliac arteriesPatients treated by caesarean hysterectomy without prior placement of prophylactic occlusion balloons of both internal iliac arteries |
| Group2: | – | Procedure: caesarean hysterectomy with prior placement of prophylactic occlusion balloons of both internal iliac arteriesPatients treated by caesarean hysterectomy with prior placement of prophylactic occlusion balloons of both internal iliac arteries |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- We collected 38 patients who were divided into two groups: Group 1 (n=22), Group 2 (n=16).
Key inclusion criteria (2 listed)
- placenta accreta spectrum disorder (PASD) confirmed by histopathological examination.
- caesarean hysterectomy.
Key exclusion criteria (2 listed)
- placenta accreta suspected in MRI fundings but disproved in in histopathological examination.
- conservative treatment of PASD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| caesarean hysterectomy with prior placement of prophylactic occlusion balloons of both internal iliac arteriesPreoperative 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. | Procedure or surgery | Group2: |
| caesarean hysterectomy without prior placement of prophylactic occlusion balloons of both internal iliac arteriesCaesarean 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. | Procedure or surgery | Group1 |
Primary outcome
calculated blood loss
Time frame: peroperatively
The blood losses were calculated by weighing the surgical drapes and compresses and quantifying the aspirated bleeding
Transfusion peroperatively
Time frame: First 24 hours]
peroperatively
Duration of surgery
Time frame: peroperatively
MINUTES
Postoperative hospital stay
Time frame: up to 40 days postpartum
DAYS
Postoperative transfer to the intensive care unit
Time frame: up to 40 days postpartum
NUMBER
1 secondary outcome
Morbidity
Time frame: time from surgery up to 30 days postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haithem Aloui, Doctor principal investigator
Tunis University Manar
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhage and Placenta Accreta Spectrum, run by Tunis University at 2 sites in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
calculated blood loss (time frame: peroperatively). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.