Blood LossPhase 3NCT03824873
Internal Iliac Artery Ligation Before Cesarean Hysterectomy in Morbidly Adherent Placenta
A Phase 3 study testing Internal iliac artery ligation and cesarean hysterectomy in people with Blood Loss, run by Ain Shams University at 1 site in Egypt.
Trial summary
40 pregnant females at term diagnosed with morbidly adherent placenta and planned for elective cesarean section were recruited and randomized to 2 groups. Group A: Internal iliac ligation followed by cesarean hysterectomy. Group B: cesarean hysterectomy. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Blood Loss
- 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
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2017to 2 Jul 2020
- Phase
- Phase 3
- 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 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Placenta previa accreta
- Previous 2 cesarean section
- completed her family
- Hemoglobin > 11 gm/dl
- Elective cesarean hysterectomy
Who cannot join
- Anemia ( Hemoglobin < 11 gm/dl)
- Not completed her family
- BMI > 35 Kg/m2
- Bleeding tendency
- Emergengy cesarean section
- Thrombophilia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internal Iliac Artery Ligation Before Cesarean Hysterectomy in Morbidly Adherent Placenta: A Randomized Clinical Trial
40 pregnant females at term diagnosed with morbidly adherent placenta and planned for elective cesarean section were recruited and randomized to 2 groups. Group A: Internal iliac ligation followed by cesarean hysterectomy. Group B: cesarean hysterectomy.
- Conditions
- Blood Loss
- Being tested
- Internal iliac artery ligation, cesarean hysterectomy
- Keywords
- Internal iliac artery, Internal iliac artery ligation, Placenta previa, Placenta accreta, cesarean hysterectomy
- Medical subject headings
- Hemorrhage, Placenta Previa, 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
Also called cesarean hysterectomy
Internal iliac artery ligation and cesarean hysterectomy
cesarean hysterectomyProcedure or surgery
cesarean hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| internal iliac artery ligation + cesarean hysterectomy | Active comparator | Not described Receives: Procedure: Internal iliac artery ligation; Procedure: cesarean hysterectomy |
| cesarean hysterectomy | Active comparator | Not described Receives: Procedure: cesarean hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of blood loss
Measured: intraoperative
Amount of Blood transfusion needed in mililiters
Measured: 24 hours
Secondary outcomes (4)
change of hemoglobin
Measured: 24 hours
change of hematocrit
Measured: 24 hours
operative time
Measured: intraoperative
incidence of injury of important structures during operation
incidence of injury of important structures during operation as urinary bladder, ureteric, intestinal or great vessels injury
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start1 Mar 2017
- Primary completion1 Jan 2020
- Study completion2 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood LossStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed S Sweed, MD, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824873
- Sponsor's protocol ID
- AS1862
- Status last verified
- Jul 2020
- First submitted
- 26 Jan 2019
- Last updated
- 8 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internal Iliac Artery Ligation Before Cesarean Hysterectomy in Morbidly Adherent Placenta: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03824873
- Acronym / sponsor ID
- AS1862
- Conditions
- Blood Loss
- Keywords
- Internal iliac artery, Internal iliac artery ligation, Placenta previa, Placenta accreta, cesarean hysterectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 2 Jul 2020 (actual)
- First posted
- 31 Jan 2019 (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.
40 pregnant females at term diagnosed with morbidly adherent placenta and planned for elective cesarean section were recruited and randomized to 2 groups. Group A: Internal iliac ligation followed by cesarean hysterectomy. Group B: cesarean hysterectomy.
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 + cesarean hysterectomy | Active comparator | Procedure: Internal iliac artery ligation, Procedure: cesarean hysterectomy |
| cesarean hysterectomy | Active comparator | Procedure: cesarean hysterectomy |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Placenta previa accreta
- Previous 2 cesarean section
- completed her family
- Hemoglobin > 11 gm/dl
- Elective cesarean hysterectomy
Key exclusion criteria (6 listed)
- Anemia ( Hemoglobin < 11 gm/dl)
- Not completed her family
- BMI > 35 Kg/m2
- Bleeding tendency
- Emergengy cesarean section
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 ligationAlso: cesarean hysterectomyInternal iliac artery ligation and cesarean hysterectomy | Procedure or surgery | internal iliac artery ligation + cesarean hysterectomy |
| cesarean hysterectomycesarean hysterectomy | Procedure or surgery | cesarean hysterectomy, internal iliac artery ligation + cesarean hysterectomy |
Primary outcome
Amount of blood loss
Time frame: intraoperative
Amount of Blood transfusion needed in mililiters
Time frame: 24 hours
4 secondary outcomes
change of hemoglobin
Time frame: 24 hours
change of hematocrit
Time frame: 24 hours
operative time
Time frame: intraoperative
incidence of injury of important structures during operation
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 8 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Blood Loss
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
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 Phase 3 study testing Internal iliac artery ligation and cesarean hysterectomy in people with Blood Loss, run by Ain Shams 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 5 inclusion and 6 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 8 Jul 2020. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 blood loss (time frame: intraoperative). The study lists 2 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 8 Jul 2020.