Placenta PercretaNCT02728232
Internal Iliac Artery Ligation and Abnormally Invasive Placenta
A study testing internal iliac artery ligation and Cesarean Hysterectomy in people with Placenta Percreta, run by Cairo University at 1 site in Egypt.
Trial summary
This trial is set to detect the impact of bilateral internal iliac artery ligation on the amount of intra-operative blood loss during the hysterectomy procedure done for the management of abnormally invasive placenta Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Percreta
- What is being tested?
- internal iliac artery ligation and Cesarean Hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2016to 1 Apr 2017
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- females with pre-operative diagnosis of abnormally invasive placenta
Who cannot join
- refusal to get enrolled in the study
Trial locations and contacts
1 site in 1 country.
About this study
This trial is set to detect the impact of bilateral internal iliac artery ligation on the amount of intra-operative blood loss during the hysterectomy procedure done for the management of abnormally invasive placenta
- Conditions
- Placenta Percreta
- Being tested
- internal iliac artery ligation, Cesarean Hysterectomy
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internal iliac artery ligationProcedure or surgery
Cesarean HysterectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Internal Iliac artery ligation group | Experimental | in this group the patients will undergo bilateral internal iliac artery ligation prior to the hysterectomy procedure Receives: Procedure: internal iliac artery ligation; Procedure: Cesarean Hysterectomy |
| Hysterectomy only | Active comparator | in this group patients will undergo cesarean hysterectomy only Receives: Procedure: Cesarean Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of intra-operative hemorrhage
Measured: 2-3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion1 Apr 2017
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta PercretaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahmoud Hussein, Cairo University
- Investigators
- Ahmed M Hussein, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728232
- Sponsor's protocol ID
- PP2302019
- Status last verified
- Apr 2017
- First submitted
- 31 Mar 2016
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internal Iliac Artery Ligation and Abnormally Invasive Placenta
- ClinicalTrials.gov ID
- NCT02728232
- Acronym / sponsor ID
- PP2302019
- Conditions
- Placenta Percreta
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 5 Apr 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.
This trial is set to detect the impact of bilateral internal iliac artery ligation on the amount of intra-operative blood loss during the hysterectomy procedure done for the management of abnormally invasive placenta
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internal Iliac artery ligation group | Experimental | Procedure: internal iliac artery ligation, Procedure: Cesarean Hysterectomyin this group the patients will undergo bilateral internal iliac artery ligation prior to the hysterectomy procedure |
| Hysterectomy only | Active comparator | Procedure: Cesarean Hysterectomyin this group patients will undergo cesarean hysterectomy only |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- females with pre-operative diagnosis of abnormally invasive placenta
Key exclusion criteria (1 listed)
- refusal to get enrolled in the study
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 |
|---|---|---|
| internal iliac artery ligation | Procedure or surgery | Internal Iliac artery ligation group |
| Cesarean Hysterectomy | Procedure or surgery | Hysterectomy only, Internal Iliac artery ligation group |
Primary outcome
amount of intra-operative hemorrhage
Time frame: 2-3 hours
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 18 Apr 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Placenta Percreta
Not yet recruitingObservational study
Prediction of Placenta Accreta Outcome in Pregnant Woman With Placenta Previa Using (hcg_h ) as Abiomarkers
Placenta Accreta / Percreta
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.
Ahmed M Hussein, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing internal iliac artery ligation and Cesarean Hysterectomy in people with Placenta Percreta, run by Cairo 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 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 18 Apr 2017. 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 intra-operative hemorrhage (time frame: 2-3 hours). 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 18 Apr 2017.