Placenta AccretaNCT03129035
Bilateral Internal Iliac Artery Ligation Before Cesarean Hysterectomy
A study testing Cesarean hystrectomy and Internal iliac artery ligation in people with Placenta Accreta, run by Cairo University at 1 site in Egypt.
Trial summary
All women with placenta accreta will be managed by upper segment cesarean section followed by cesarean hysterectomy without attempts of placental removal. Women were randomized to either bilateral internal iliac artery ligation before hysterectomy and after fetal extraction or no additional intervention Read more about this study
- Who is it for?
- Ages 20 to 44 years, women only
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- Cesarean hystrectomy and Internal iliac artery ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- May 2017to Feb 2018
- 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 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women with suspected placenta accreta
- Scarred uterus
- Approving hysterectomy
Who cannot join
- Women needed conservative surgery
- women with coagulopathy or bleeding disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bilateral Internal Iliac Artery Ligation Before Cesarean Hysterectomy : A Randomized Controlled Trial
All women with placenta accreta will be managed by upper segment cesarean section followed by cesarean hysterectomy without attempts of placental removal.
Women were randomized to either bilateral internal iliac artery ligation before hysterectomy and after fetal extraction or no additional intervention
Read the detailed description
All women with placenta accreta will be managed by upper segment cesarean section followed by cesarean hysterectomy without attempts of placental removal.
Women were randomized to either bilateral internal iliac artery ligation before hysterectomy and after fetal extraction or no additional intervention.
Midline incision in the all patients is preferred. The retroperitoneal space was entered at the level of common iliac bifurcation and followed to the point of division into the external and internal iliac arteries. The ureter was retracted medially by gentle finger dissection, revealing the retroperitoneal anatomy. The fat and loose connective tissue around the IIA and vein were removed and a right-angle clamp was passed beneath the IIA from the lateral to the medial side approximately 4 cm distal to its origin.
Using an absorbable suture, the IIA was ligated doubly in all cases . Pulsations of the external iliac and femoral arteries were identified after internal iliac ligation. The procedure was then repeated on the other side.
- Conditions
- Placenta Accreta
- Being tested
- Cesarean hystrectomy, Internal iliac artery ligation
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cesarean hystrectomyProcedure or surgery
Upper segment cesarean section followed by fetal extraction and cesarean hystrectomy started without any attempts of placental removal
Internal iliac artery ligationProcedure or surgery
The retroperitoneal space was entered at the level of common iliac bifurcation and followed to the point of division into the external and internal iliac arteries. The ureter was retracted medially by gentle finger dissection, revealing the retroperitoneal anatomy. The fat and loose connective tissue around the IIA and vein were removed and a right-angle clamp was passed beneath the IIA from the lateral to the medial side approximately 4 cm distal to its origin. Using an absorbable suture, the IIA was ligated doubly in all cases . Pulsations of the external iliac and femoral arteries were identified after internal iliac ligation. The procedure was then repeated on the other side
| Study group | Role | What they receive |
|---|---|---|
| internal iliac artery ligation | Active comparator | women undergo bilateral internal iliac artery ligation after fetal extraction and before proceeding in cesarean hysterectomy Receives: Procedure: Cesarean hystrectomy; Procedure: Internal iliac artery ligation |
| No internal iliac artery ligation | Active comparator | Women undergo cesarean hysterectomy after fetal extraction Receives: Procedure: Cesarean hystrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants needed blood transfusion
number of cases in each group who needed blood transfusion whether intraoperative or within 24 hours postoperative
Measured: within 24 hours from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study startMay 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta AccretaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, Kasr Alainy medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129035
- Sponsor's protocol ID
- 4
- Status last verified
- Apr 2017
- First submitted
- 20 Apr 2017
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Internal Iliac Artery Ligation Before Cesarean Hysterectomy : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03129035
- Acronym / sponsor ID
- 4
- Conditions
- Placenta Accreta
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 26 Apr 2017 (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.
All women with placenta accreta will be managed by upper segment cesarean section followed by cesarean hysterectomy without attempts of placental removal.
Women were randomized to either bilateral internal iliac artery ligation before hysterectomy and after fetal extraction or no additional intervention
Detailed description
All women with placenta accreta will be managed by upper segment cesarean section followed by cesarean hysterectomy without attempts of placental removal.
Women were randomized to either bilateral internal iliac artery ligation before hysterectomy and after fetal extraction or no additional intervention.
Midline incision in the all patients is preferred. The retroperitoneal space was entered at the level of common iliac bifurcation and followed to the point of division into the external and internal iliac arteries. The ureter was retracted medially by gentle finger dissection, revealing the retroperitoneal anatomy. The fat and loose connective tissue around the IIA and vein were removed and a right-angle clamp was passed beneath the IIA from the lateral to the medial side approximately 4 cm distal to its origin.
Using an absorbable suture, the IIA was ligated doubly in all cases . Pulsations of the external iliac and femoral arteries were identified after internal iliac ligation. The procedure was then repeated on the other side.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| internal iliac artery ligation | Active comparator | Procedure: Cesarean hystrectomy, Procedure: Internal iliac artery ligationwomen undergo bilateral internal iliac artery ligation after fetal extraction and before proceeding in cesarean hysterectomy |
| No internal iliac artery ligation | Active comparator | Procedure: Cesarean hystrectomyWomen undergo cesarean hysterectomy after fetal extraction |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- women with suspected placenta accreta
- Scarred uterus
- Approving hysterectomy
Key exclusion criteria (2 listed)
- Women needed conservative surgery
- women with coagulopathy or bleeding disorders
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 |
|---|---|---|
| Cesarean hystrectomyUpper segment cesarean section followed by fetal extraction and cesarean hystrectomy started without any attempts of placental removal | Procedure or surgery | No internal iliac artery ligation, internal iliac artery ligation |
| Internal iliac artery ligationThe retroperitoneal space was entered at the level of common iliac bifurcation and followed to the point of division into the external and internal iliac arteries. The ureter was retracted medially by gentle finger dissection, revealing the retroperitoneal anatomy. The fat and loose connective tissue around the IIA and vein were removed and a right-angle clamp was passed beneath the IIA from the lateral to the medial side approximately 4 cm distal to its origin. Using an absorbable suture, the IIA was ligated doubly in all cases . Pulsations of the external iliac and femoral arteries were identified after internal iliac ligation. The procedure was then repeated on the other side | Procedure or surgery | internal iliac artery ligation |
Primary outcome
Number of participants needed blood transfusion
Time frame: within 24 hours from surgery
number of cases in each group who needed blood transfusion whether intraoperative or within 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Individual participant dataSharing planned: Yes
Related trials for Placenta Accreta
Not yet recruitingObservational study
Placenta-Cervical Interface Angle for Predicting Placenta Accreta Spectrum Severity
Placenta Accreta Spectrum, Placenta Previa
Not yet recruitingObservational study
Hematological and Coagulation Markers in Predicting Placenta Accreta Spectrum in Placenta Previa
Placenta Accreta Spectrum, Placenta Previa
Not yet recruitingObservational study
Ultrasound Scoring System for Diagnosis and Prediction of Severity and Surgical Outcomes of Placenta Accreta Spectrum
Placenta Accreta, Third Trimester
Not yet recruitingObservational study
Total Lower Uterine Segmentectomy With Adjunctive Mechanical Towel Compression for the Surgical Management of Placenta Accreta Spectrum Disorders
Placenta Accreta Management
Recruiting
Comparison Between 3 Conservative Surgeries for Placenta Accreta Spectrum
Placenta Accreta Spectrum
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 Maged, MD principal investigator
Kasr Alainy medical school
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cesarean hystrectomy and Internal iliac artery ligation in people with Placenta Accreta, 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 3 inclusion and 2 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 26 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Maged, MD (01005227404, prof.ahmedmaged@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants needed blood transfusion (time frame: within 24 hours from surgery). 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 Apr 2017; AzTrials last refreshed its copy on 6 Nov 2026.