Internal Iliac ArteryNCT06562712
Evaluation of Bilateral Internal Iliac Artery Balloon Occlusion in Placenta Accreta Spectrum Management
A study testing Conventional management and Bilateral internal iliac artery balloon occlusion in people with Internal Iliac Artery and Balloon Occlusion, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate the efficacy and safety of bilateral internal iliac artery balloon occlusion in the management of the placenta accreta spectrum. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Internal Iliac Artery, Balloon Occlusion, Placenta Accreta Spectrum
- What is being tested?
- Conventional management and Bilateral internal iliac artery balloon occlusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2024to 1 Dec 2024
- Phase
- Interventional
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age from 18 to 40 years.
- Women with placenta accreta spectrum based on ultrasound (US) and/or magnetic resonance imaging (MRI) findings.
Who cannot join
- Women with a bleeding disorder.
- History of known allergy to contrast media.
- Women with Impaired renal function.
- Emergency cesarean section.
- Women had severe attack of bleeding before the operation affecting patient's general condition.
- Women had previous four or more cesarean scars.
- If ultrasound (US) and magnetic resonance imaging (MRI) suspect the presence of placenta accrete preoperative, then intraoperative the placenta is found to have normal adhesion to the uterine wall, this case will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Bilateral Internal Iliac Artery Balloon Occlusion in Placenta Accreta Spectrum Management: A Randomized Controlled Trial
This study aims to evaluate the efficacy and safety of bilateral internal iliac artery balloon occlusion in the management of the placenta accreta spectrum.
Read the detailed description
Placenta accreta spectrum (PAS) is abnormal placental adhesion beyond superficial myometrium, which includes placenta accreta, placenta increta, and placenta percreta.
However, there is a desire to preserve the uterus and fertility, so alternatives to hysterectomy are needed. Presently, attempts to avoid hysterectomy include reducing intraoperative hemorrhage such as uterine compression sutures, intrauterine balloon tamponade, pelvic artery ligation, and spiral suturing of the lower uterine segment. Intrauterine balloon tamponade may increase CS scar dehiscence, uterine rupture, and infection. Combined with compression sutures, it may induce uterine necrosis.
Placement of balloons in the bilateral internal iliac arteries before caesarean section can reduce uterine artery pressure and intraoperative blood loss during balloon inflation, thus temporarily blocking the main blood supply of the uterus, helping to expose the visual field, shortening the operation time during surgery, and leading to opportunities for timely adjustments to the operative plan during surgery.
- Being tested
- Conventional management, Bilateral internal iliac artery balloon occlusion
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional managementProcedure or surgery
Patients will be subjected to conventional management for placenta accreta spectrum.
Bilateral internal iliac artery balloon occlusionProcedure or surgery
Patients will be subjected to bilateral internal iliac artery balloon occlusion for placenta accreta spectrum.
| Study group | Role | What they receive |
|---|---|---|
| Conventional management | Active comparator | Patients will be subjected to conventional management for placenta accreta spectrum. Receives: Procedure: Conventional management |
| Bilateral internal iliac artery balloon occlusion | Experimental | Patients will be subjected to bilateral internal iliac artery balloon occlusion for placenta accreta spectrum. Receives: Procedure: Bilateral internal iliac artery balloon occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of intraoperative blood loss
The amount of intraoperative blood loss will be calculated with reference to the contents of the suction apparatus and to weight of the surgical pads and the hemoglobin concentration difference, immediate preoperative (the morning of cesarean delivery) and postoperative (immediately after cesarean delivery) hemoglobin levels.
Measured: Intraoperatively
Secondary outcomes (6)
Operation time
Operation time will be recorded from start till end of surgery.
Measured: From the start till the end of surgery
Number of blood products units transfused
Number of blood products units transfused will be recorded.
Measured: 24 hours postoperatively
Hospitalization length
Hospitalization length will be recorded from admission till discharge from hospital.
Measured: 28 days postoperatively
Incidence of hysterectomy
Incidence of hysterectomy will be recorded.
Measured: 24 hours postoperatively
Intensive Care Unit (ICU) admission rate
Intensive Care Unit (ICU) admission rate will be recorded.
Measured: 24 hours postoperatively
Intraoperative complications
Intraoperative complications such as bladder injury, ureteric ligature, and uterine atony will be recorded.
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start20 Aug 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internal Iliac ArteryStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ibrahim Adel Eleissawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562712
- Sponsor's protocol ID
- 36264PR753/7/24
- Status last verified
- Jun 2025
- First submitted
- 15 Aug 2024
- Last updated
- 26 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bilateral Internal Iliac Artery Balloon Occlusion in Placenta Accreta Spectrum Management: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06562712
- Acronym / sponsor ID
- 36264PR753/7/24
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 20 Aug 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.
This study aims to evaluate the efficacy and safety of bilateral internal iliac artery balloon occlusion in the management of the placenta accreta spectrum.
Detailed description
Placenta accreta spectrum (PAS) is abnormal placental adhesion beyond superficial myometrium, which includes placenta accreta, placenta increta, and placenta percreta.
However, there is a desire to preserve the uterus and fertility, so alternatives to hysterectomy are needed. Presently, attempts to avoid hysterectomy include reducing intraoperative hemorrhage such as uterine compression sutures, intrauterine balloon tamponade, pelvic artery ligation, and spiral suturing of the lower uterine segment. Intrauterine balloon tamponade may increase CS scar dehiscence, uterine rupture, and infection. Combined with compression sutures, it may induce uterine necrosis.
Placement of balloons in the bilateral internal iliac arteries before caesarean section can reduce uterine artery pressure and intraoperative blood loss during balloon inflation, thus temporarily blocking the main blood supply of the uterus, helping to expose the visual field, shortening the operation time during surgery, and leading to opportunities for timely adjustments to the operative plan during surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional management | Active comparator | Procedure: Conventional managementPatients will be subjected to conventional management for placenta accreta spectrum. |
| Bilateral internal iliac artery balloon occlusion | Experimental | Procedure: Bilateral internal iliac artery balloon occlusionPatients will be subjected to bilateral internal iliac artery balloon occlusion for placenta accreta spectrum. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age from 18 to 40 years.
- Women with placenta accreta spectrum based on ultrasound (US) and/or magnetic resonance imaging (MRI) findings.
Key exclusion criteria (7 listed)
- Women with a bleeding disorder.
- History of known allergy to contrast media.
- Women with Impaired renal function.
- Emergency cesarean section.
- Women had severe attack of bleeding before the operation affecting patient's general condition.
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 |
|---|---|---|
| Conventional managementPatients will be subjected to conventional management for placenta accreta spectrum. | Procedure or surgery | Conventional management |
| Bilateral internal iliac artery balloon occlusionPatients will be subjected to bilateral internal iliac artery balloon occlusion for placenta accreta spectrum. | Procedure or surgery | Bilateral internal iliac artery balloon occlusion |
Primary outcome
Amount of intraoperative blood loss
Time frame: Intraoperatively
The amount of intraoperative blood loss will be calculated with reference to the contents of the suction apparatus and to weight of the surgical pads and the hemoglobin concentration difference, immediate preoperative (the morning of cesarean delivery) and postoperative (immediately after cesarean delivery) hemoglobin levels.
6 secondary outcomes
Operation time
Time frame: From the start till the end of surgery
Number of blood products units transfused
Time frame: 24 hours postoperatively
Hospitalization length
Time frame: 28 days postoperatively
Incidence of hysterectomy
Time frame: 24 hours postoperatively
Intensive Care Unit (ICU) admission rate
Time frame: 24 hours postoperatively
Intraoperative complications
Time frame: Intraoperatively
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 26 Jun 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional management and Bilateral internal iliac artery balloon occlusion in people with Internal Iliac Artery and Balloon Occlusion, run by Tanta University at 1 site in Egypt.
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 7 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 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
Amount of intraoperative blood loss (time frame: Intraoperatively). 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 26 Jun 2025.