Placenta AccretaNCT04423263
Internal Iliac Artery Occlusion in Placenta Accreta
A study testing Bilateral internal iliac artery balloon occlusion in people with Placenta Accreta, run by Voon Hian Yan.
Trial summary
This is a randomized study to assess the efficacy of prophylactic bilateral internal iliac artery occlusion performed prior to planned surgical management for placenta accreta spectrum (PAS). Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- 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
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 31 Dec 2023
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All pregnant women with prenatally diagnosed placenta accreta spectrum
Who cannot join
- Women who declined to participate
- Women with bleeding diathesis or severe thrombocytopenia <100k x 1,000,000/L
- Surgery performed prior to 28 weeks of gestation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Perioperative Prophylactic Bilateral Internal Iliac Artery Occlusion in Placenta Accreta: a Randomized Trial
This is a randomized study to assess the efficacy of prophylactic bilateral internal iliac artery occlusion performed prior to planned surgical management for placenta accreta spectrum (PAS). The intervention group would receive balloon occlusion, ureteric stenting and caesaeran hysterectomy while the control group would undergo the same procedure, excluding balloon occlusion. The primary outcome is to demonstrate a three pint or greater reduction in pack cell transfusion requirement.
Read the detailed description
Interventional radiology, including internal iliac artery occlusion, has been used as an adjunct in the management of placenta accreta spectrum (PAS). Retrospective studies have shown benefit in terms of reduction of blood loss. However, studies reported in literature vary widely in terms of the exact surgical procedure undertaken, in conjunction with the radiological intervention. The radiological intervention itself lacks standardization, occurring at different anatomical levels, ranging from infrarenal aortic occlusion to internal iliac or uterine artery. Furthermore, there have been reported cases of arterial thrombosis associated with arterial occlusion.
We sought to clarify the effectiveness of a standardized approach , where perioperative bilateral internal iliac artery occlusion is performed followed by bilateral ureteric stenting and caesarean hysterectomy. The control group would undergo the exact procedure, excluding internal iliac artery occlusion. Patients would be randomized but neither the patient nor surgeon could be blinded.
The primary outcome would be to demonstrate a three pint or greater reduction in packed cell transfusion. Secondary outcomes include a difference in estimated blood loss, additional blood product transfusion, unplanned additional surgical procedure, serious complications arising from internal iliac artery occlusion, total procedural time and early neonatal outcome.
- Conditions
- Placenta Accreta
- Being tested
- Bilateral internal iliac artery balloon occlusion, Control
- Keywords
- balloon occlusion, iliac artery, interventional radiology, postpartum hemorrhage, blood transfusion
- Medical subject headings
- Placenta Accreta, Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral internal iliac artery balloon occlusionProcedure or surgery
Bilateral internal iliac artery balloon placement under fluoroscopic guidance preoperatively which will be occluded intraoperatively based on existing local protocol
ControlProcedure or surgery
Surgical approach similar to intervention arm, except bilateral internal iliac artery occlusion
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Receives bilateral internal iliac artery occlusion Receives: Procedure: Bilateral internal iliac artery balloon occlusion |
| Control | Active comparator | Does not receive bilateral internal iliac artery occlusion Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pack cell transfusion
To detect a three pint reduction in pack cell transfusion
Measured: First 7 days post-operatively
Secondary outcomes (3)
Other blood components
Platelets, fresh fozen plasma, cryoprecipitate
Measured: First 7 days post-operatively
Unplanned perioperative surgical procedures
Internal iliac artery ligation, abdominal packing, relaparotomy
Measured: First 7 days post-operatively
Complication from internal iliac occlusion
death, arterial thrombosis, aneurysm, hematoma requiring evacuation
Measured: First 14 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Jul 2020 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Placenta AccretaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Voon Hian Yan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Voon Hian Yan, Sarawak General Hospital
- Investigators
- Hian Yan Voon, MRCOG, Principal investigator, Sarawak General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423263
- Sponsor's protocol ID
- Research ID 55302
- Status last verified
- Jun 2020
- First submitted
- 5 Jun 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and anonymized information including demographics, primary and secondary outcomes
Publications
Chen M, Liu X, You Y, Wang X, Li T, Luo H, Qu H, Xu L. Internal Iliac Artery Balloon Occlusion for Placenta Previa and Suspected Placenta Accreta: A Randomized Controlled Trial. Obstet Gynecol. 2020 May;135(5):1112-1119. doi: 10.1097/AOG.0000000000003792.
PubMed 32282608Salim R, Chulski A, Romano S, Garmi G, Rudin M, Shalev E. Precesarean Prophylactic Balloon Catheters for Suspected Placenta Accreta: A Randomized Controlled Trial. Obstet Gynecol. 2015 Nov;126(5):1022-1028. doi: 10.1097/AOG.0000000000001113.
PubMed 26444128
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Prophylactic Bilateral Internal Iliac Artery Occlusion in Placenta Accreta: a Randomized Trial
- ClinicalTrials.gov ID
- NCT04423263
- Acronym / sponsor ID
- Research ID 55302
- Conditions
- Placenta Accreta
- Keywords
- balloon occlusion, iliac artery, interventional radiology, postpartum hemorrhage, blood transfusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Voon Hian YanUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Jun 2020 (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 is a randomized study to assess the efficacy of prophylactic bilateral internal iliac artery occlusion performed prior to planned surgical management for placenta accreta spectrum (PAS). The intervention group would receive balloon occlusion, ureteric stenting and caesaeran hysterectomy while the control group would undergo the same procedure, excluding balloon occlusion. The primary outcome is to demonstrate a three pint or greater reduction in pack cell transfusion requirement.
Detailed description
Interventional radiology, including internal iliac artery occlusion, has been used as an adjunct in the management of placenta accreta spectrum (PAS). Retrospective studies have shown benefit in terms of reduction of blood loss. However, studies reported in literature vary widely in terms of the exact surgical procedure undertaken, in conjunction with the radiological intervention. The radiological intervention itself lacks standardization, occurring at different anatomical levels, ranging from infrarenal aortic occlusion to internal iliac or uterine artery. Furthermore, there have been reported cases of arterial thrombosis associated with arterial occlusion.
We sought to clarify the effectiveness of a standardized approach , where perioperative bilateral internal iliac artery occlusion is performed followed by bilateral ureteric stenting and caesarean hysterectomy. The control group would undergo the exact procedure, excluding internal iliac artery occlusion. Patients would be randomized but neither the patient nor surgeon could be blinded.
The primary outcome would be to demonstrate a three pint or greater reduction in packed cell transfusion. Secondary outcomes include a difference in estimated blood loss, additional blood product transfusion, unplanned additional surgical procedure, serious complications arising from internal iliac artery occlusion, total procedural time and early neonatal outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Bilateral internal iliac artery balloon occlusionReceives bilateral internal iliac artery occlusion |
| Control | Active comparator | Procedure: ControlDoes not receive bilateral internal iliac artery occlusion |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All pregnant women with prenatally diagnosed placenta accreta spectrum
Key exclusion criteria (3 listed)
- Women who declined to participate
- Women with bleeding diathesis or severe thrombocytopenia <100k x 1,000,000/L
- Surgery performed prior to 28 weeks of gestation
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 |
|---|---|---|
| Bilateral internal iliac artery balloon occlusionBilateral internal iliac artery balloon placement under fluoroscopic guidance preoperatively which will be occluded intraoperatively based on existing local protocol | Procedure or surgery | Intervention |
| ControlSurgical approach similar to intervention arm, except bilateral internal iliac artery occlusion | Procedure or surgery | Control |
Primary outcome
Pack cell transfusion
Time frame: First 7 days post-operatively
To detect a three pint reduction in pack cell transfusion
3 secondary outcomes
Other blood components
Time frame: First 7 days post-operatively
Unplanned perioperative surgical procedures
Time frame: First 7 days post-operatively
Complication from internal iliac occlusion
Time frame: First 14 days post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Background: PubMed 32282608Chen M, Liu X, You Y, Wang X, Li T, Luo H, Qu H, Xu L. Internal Iliac Artery Balloon Occlusion for Placenta Previa and Suspected Placenta Accreta: A Randomized Controlled Trial. Obstet Gynecol. 2020 May;135(5):1112-1119. doi: 10.1097/AOG.0000000000003792.
- Background: PubMed 26444128Salim R, Chulski A, Romano S, Garmi G, Rudin M, Shalev E. Precesarean Prophylactic Balloon Catheters for Suspected Placenta Accreta: A Randomized Controlled Trial. Obstet Gynecol. 2015 Nov;126(5):1022-1028. doi: 10.1097/AOG.0000000000001113.
- Individual participant dataSharing planned: Yes. Study protocol and anonymized information including demographics, primary and secondary outcomes
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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.
Hian Yan Voon, MRCOG principal investigator
Sarawak General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral internal iliac artery balloon occlusion in people with Placenta Accreta, run by Voon Hian Yan.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hian Yan Voon, MRCOG (+6082 276666, vhaxyn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pack cell transfusion (time frame: First 7 days post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04423263, which also lists 2 linked publications.
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 9 Jun 2020.