Placenta PreviaNCT02966197
Efficacy of Prophylactic Internal Iliac Artery Balloon Catheterization in the Management of Placenta Previa and Accreta
A study testing prophylactic internal iliac artery balloon catheterization, Prophylactic internal iliac artery balloon and Radiology operation in people with Placenta Previa and Placenta Accreta, run by Deng Dongrui.
Trial summary
Placenta previa and accreta both could potentially cause serious postpartum hemorrhage and even maternal death. Interventional radiological techniques have been developed to limit massive hemorrhage during caesarean section. Read more about this study
- Who is it for?
- Ages 15 to 60 years, women only
- Conditions the study is for
- Placenta Previa, Placenta Accreta
- What is being tested?
- prophylactic internal iliac artery balloon catheterization, Prophylactic internal iliac artery balloon and Radiology operation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Sep 2016
- 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 15 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pregnant women were eligible if they were diagnosed to have placenta previa and accreta by sonographic examination or Magnetic Resonance Imaging.
Who cannot join
- Any case who had bleeding disorder or underwent emergency cesarean delivery was excluded.
About this study
Official title: the Efficacy of Prophylactic Internal Iliac Artery Balloon Catheterization in the Management of Placenta Previa and Accreta
Placenta previa and accreta both could potentially cause serious postpartum hemorrhage and even maternal death. Interventional radiological techniques have been developed to limit massive hemorrhage during caesarean section. This study investigated the efficacy of prophylactic internal iliac artery balloon catheterization in management for placenta previa and accreta.
Read the detailed description
Placenta previa and accreta both could potentially cause serious postpartum hemorrhage and even maternal death. Interventional radiological techniques have been developed to limit massive hemorrhage during caesarean section. This study investigated the efficacy of prophylactic internal iliac artery balloon catheterization in management for placenta previa and accreta. Between June 2015 and August 2016,patients were personally recruited and managed by the authors,and assigned to either balloon group or control group by their willingness to catheterization or not. Both groups benefitted similar management protocol with the exception of interventional radiology operation. Intraoperative blood loss, transfusion volume, radiation dose, exposure time, surgical duration, procedure complications and neonatal outcomes were analyzed.
- Conditions
- Placenta Previa, Placenta Accreta
- Being tested
- prophylactic internal iliac artery balloon catheterization, Prophylactic internal iliac artery balloon, Radiology operation
- Medical subject headings
- Placenta Previa, Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prophylactic internal iliac artery balloon catheterizationProcedure or surgery
Between June 2015 and August 2016
Prophylactic internal iliac artery balloonDevice
Radiology operationRadiation
| Study group | Role | What they receive |
|---|---|---|
| Balloon group | Experimental | Prophylactic Internal Iliac Artery Balloon Catheterization Receives: Procedure: prophylactic internal iliac artery balloon catheterization; Device: Prophylactic internal iliac artery balloon; Radiation: Radiology operation |
| Control group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood loss
Measured: intraoperative
Secondary outcomes (3)
operation duration
Measured: intraoperative
fluid transfusion
Measured: intraoperative
blood transfusion
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startJun 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta PreviaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deng Dongrui
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Deng Dongrui, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966197
- Sponsor's protocol ID
- TJ-C20150516
- Status last verified
- Nov 2016
- First submitted
- 15 Nov 2016
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Efficacy of Prophylactic Internal Iliac Artery Balloon Catheterization in the Management of Placenta Previa and Accreta
- ClinicalTrials.gov ID
- NCT02966197
- Acronym / sponsor ID
- TJ-C20150516
- Conditions
- Placenta Previa, Placenta Accreta
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Deng DongruiUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 17 Nov 2016 (estimated)
- 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.
Placenta previa and accreta both could potentially cause serious postpartum hemorrhage and even maternal death. Interventional radiological techniques have been developed to limit massive hemorrhage during caesarean section. This study investigated the efficacy of prophylactic internal iliac artery balloon catheterization in management for placenta previa and accreta.
Detailed description
Placenta previa and accreta both could potentially cause serious postpartum hemorrhage and even maternal death. Interventional radiological techniques have been developed to limit massive hemorrhage during caesarean section. This study investigated the efficacy of prophylactic internal iliac artery balloon catheterization in management for placenta previa and accreta. Between June 2015 and August 2016,patients were personally recruited and managed by the authors,and assigned to either balloon group or control group by their willingness to catheterization or not. Both groups benefitted similar management protocol with the exception of interventional radiology operation. Intraoperative blood loss, transfusion volume, radiation dose, exposure time, surgical duration, procedure complications and neonatal outcomes were analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balloon group | Experimental | Procedure: prophylactic internal iliac artery balloon catheterization, Device: Prophylactic internal iliac artery balloon, Radiation: Radiology operationProphylactic Internal Iliac Artery Balloon Catheterization |
| Control group | No intervention | –no intervention |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pregnant women were eligible if they were diagnosed to have placenta previa and accreta by sonographic examination or Magnetic Resonance Imaging.
Key exclusion criteria (1 listed)
- Any case who had bleeding disorder or underwent emergency cesarean delivery was excluded.
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 |
|---|---|---|
| prophylactic internal iliac artery balloon catheterizationBetween June 2015 and August 2016 | Procedure or surgery | Balloon group |
| Prophylactic internal iliac artery balloon | Device | Balloon group |
| Radiology operation | Radiation | Balloon group |
Primary outcome
blood loss
Time frame: intraoperative
3 secondary outcomes
operation duration
Time frame: intraoperative
fluid transfusion
Time frame: intraoperative
blood transfusion
Time frame: intraoperative
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 17 Nov 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing prophylactic internal iliac artery balloon catheterization, Prophylactic internal iliac artery balloon and Radiology operation in people with Placenta Previa and Placenta Accreta, run by Deng Dongrui.
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 1 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 17 Nov 2016. 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?
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?
blood loss (time frame: intraoperative). 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 17 Nov 2016.