Placenta AccretaPASIILNCT05232981
Conservative Treatment of PAS With or Without IIL
A study testing Ligation of the bilateral internal iliac arteries and Shehat's technique in people with Placenta Accreta and Cesarean Hysterectomy, run by Tanta University at 1 site in Egypt.
Trial summary
In the current study, the investigators aimed to compare the benefits of internal iliac ligation in placenta accreta spectrum Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Placenta Accreta, Cesarean Hysterectomy, Pelvic Devascularization
- What is being tested?
- Ligation of the bilateral internal iliac arteries and Shehat's technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 1 Oct 2024
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age under 35 years old.
- Prenatally diagnosed placenta accreta .
- Planned caesarean section ≤ 37 wks .
- ≤ previous 3 ceserian sections .
- Placenta accretta spectrum grade 1 , 2 ,3 .
- Patients who want to preserve their fertility.
- Patients who refuse hysterectomy .
Who cannot join
- Cases with high risk of intraoperative blood loss as hemorrhagic disorders and thrombocytopenia .
- Cases on anticoagulant therapy.
- Patients who completed her family.
- Hemodynamicaly unstable patients.
- Finally cases who refused to get enrolled in the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ayman Dawood
Tanta
Nahla Elbeheiry, Msc, +201115983165, nahla.elbeheiry@med.tanta.edu.eg
Nahla Elbeheiry, Msc
About this study
Official title: Conservative Management of Placenta Accreta Spectrum With or Without Internal Iliac Ligation: A Randomized Controlled Trial
In the current study, the investigators aimed to compare the benefits of internal iliac ligation in placenta accreta spectrum
Read the detailed description
This randomized control trial will be conducted at Tanta University hospital, Egypt, from 2022 to 2024. Tanta University Hospital is considered the main tertiary hospital at the center of Nile Delta .
Cases, suspected to have PAS, are recruited from the outpatient clinic, and subsequently transferred for ultrasonod gray scale and dopplar for assessment of placental location, invasion and commont on the fetus .
Cases are diagnosed to have PAS by the following criteria Placenta lacunae , Loss of clear zone , Bladder wall interruption, uterovesical hypervascularity and increased vascularity in inferior part of lower uterine segment extending into parametrial region9 will be included in the study. MRI will be done if ultrasonod isn't conclusive , cases with posterior placenta, depth of placental invasion, relationship to posterior bladder wall and presence of parametrial invasion .
All cases will be subjected to the following:
- A written consent will be obtained from the patients after informing them about the risk of intrapartum and postpartum hemorrhage, the need for blood transfusion, and the possibility of hysterectomy if needed to stop massive blood loss. The consent is approved by the medical ethical committee of Tanta University Hospital.
- Full history taking with special attention on:
- Age of the patient .
- Obstetric History especially number of children and sex .
- Detailed history of previous deliveries and gynecological procedures.
- History of any previous surgery.
- Full general and abdominal examination including weight, height, body mass index (BMI) and blood pressure.
- Routine lab investigation : CBC, coagulation profile ( PT , PTT , Bleeding time , Clotting time ) , ABO , RH Typing , virology .
Randamisation and Allocation :
Patients will be given aclosed envelope containing either letter C or letter I . The envelope that opened by patient will not change allocation .
The enrolled cases will be allocated into two groups with 1:1 allocation. Group 1 :( Study group ) include cases that will undergo bilateral internal iliac arteries ligation .
Group II :( Control group ) will undergo conservative management by three step technique (Shehata's technique) .
Intervention
Preoperative preparation :
Planned elective CS ≤ 37 wk unless the clinical situations necessitate earlier termination of pregnancy.
A multidisciplinary team including a two senior obstetricians, vascular surgeon , a urologist, an anesthesiologist, and a pediatrician are involved in the operation.
Four units of cross-matched blood are prepared for each patient .Ureteric catheters will be prepared to be used when indicated . Drugs that control bleeding will be preparedsuch as Oxytocin, Carbetocin, Ergometrine, Misoprostol and Tranexamic acid.
All cases undergo general anesthesia by a specialized team. The operation started with Pfannenstiel skin incision and careful dissection of urinary bladder till exposing the uterus.
Uterine incision above placental edge will be done to avoid transplacental incision that triggers heavy bleeding and then extraction of the baby with ecbolic administration, the uterus with the placenta inside will be exteriorized outside the abdomen .Redissecion of U.B will be done if previous dissection at the beginning of the surgery is insuffient.
- Being tested
- Ligation of the bilateral internal iliac arteries, Shehat's technique
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ligation of the bilateral internal iliac arteriesProcedure or surgery
opening the posterior peritoneum overlying the bifurcation of the common iliac arteries. Then careful dissection of the internal iliac artery is carried out on each side and the anterior division of the internal iliac artery is ligated 4 cm below the bifurcation of the common iliac on both sides by single ligation procedure using Vicryl 1.0 .
Re-checking of the femoral pulsation of both sides is performed. Then, the placenta is removed manually in a piecemeal manner, any remaining bleeding points from the placental site are then controlled by hemostatic sutures .
Shehat's techniqueProcedure or surgery
The three-step technique (Shehata's technique) entailed 3 steps, the first step is double bilateral ligation of uterine arteries before placental separation. Uterine artery ligation is made at 2 levels. First will be done at the isthmus and second will be done 1 cm above the cesarean incision. Regarding timing of ligation , we will apply the uterine artery ligation before placental separation to minimize blood loss at the attempt of placental separation.
Placenta is separated manually either totally or in piecemeal. If manual separation failed, placenta is removed by scissors.
Application of quadruple sutures is done at the lower uterine segment to compress and secure the neovascularization in the bed of placenta.
Insertion of triple way catheter is commenced from inside the uterine incision downwards using long artery forceps or uterine sound and the pulled by the assistant from below. The catheter balloon is inflated by 50 cc saline and left for 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Conservative management of PAS with Ligation of the bilateral internal iliac arteries Receives: Procedure: Ligation of the bilateral internal iliac arteries |
| Control group | Active comparator | Conservative treatment with Shehata's technique and no internal iliac ligation Receives: Procedure: Shehat's technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood loss
the volume of blood collected in the suction apparatus, excluding the volume of liquor collected, this will be done by meticulous recording of the blood volume in the suction apparatus before opening the uterus and then calculating the exactly added amount of liquor, so that it becomes excluded from the calculation) to the calculated volume of blood obtained from the pre and postoperative difference in weight of the towels and drapes placed beneath the patients, using the following formula: (WET Item Gram Weight - DRY Item Gram Weight¼milliliters of blood within the item) .
Measured: 6 months
Cesarean hysterectomy rate
The success of procedure in prevention of hysterectomy
Measured: 6 months
Secondary outcomes (2)
Operative time
From skin to skin duration in minutes
Measured: intraoperative
Operative and postoperative complications
Any operative organ injury
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 May 2022
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (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 Tanta 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman S Dawood, MD, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232981
- Sponsor's protocol ID
- PASIIL
- Acronym
- PASIIL
- Status last verified
- Feb 2024
- First submitted
- 28 Jan 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On valuable request
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Management of Placenta Accreta Spectrum With or Without Internal Iliac Ligation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05232981
- Acronym / sponsor ID
- PASIIL / PASIIL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 10 Feb 2022 (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.
In the current study, the investigators aimed to compare the benefits of internal iliac ligation in placenta accreta spectrum
Detailed description
This randomized control trial will be conducted at Tanta University hospital, Egypt, from 2022 to 2024. Tanta University Hospital is considered the main tertiary hospital at the center of Nile Delta .
Cases, suspected to have PAS, are recruited from the outpatient clinic, and subsequently transferred for ultrasonod gray scale and dopplar for assessment of placental location, invasion and commont on the fetus .
Cases are diagnosed to have PAS by the following criteria Placenta lacunae , Loss of clear zone , Bladder wall interruption, uterovesical hypervascularity and increased vascularity in inferior part of lower uterine segment extending into parametrial region9 will be included in the study. MRI will be done if ultrasonod isn't conclusive , cases with posterior placenta, depth of placental invasion, relationship to posterior bladder wall and presence of parametrial invasion .
All cases will be subjected to the following:
- A written consent will be obtained from the patients after informing them about the risk of intrapartum and postpartum hemorrhage, the need for blood transfusion, and the possibility of hysterectomy if needed to stop massive blood loss. The consent is approved by the medical ethical committee of Tanta University Hospital.
- Full history taking with special attention on:
- Age of the patient .
- Obstetric History especially number of children and sex .
- Detailed history of previous deliveries and gynecological procedures.
- History of any previous surgery.
- Full general and abdominal examination including weight, height, body mass index (BMI) and blood pressure.
- Routine lab investigation : CBC, coagulation profile ( PT , PTT , Bleeding time , Clotting time ) , ABO , RH Typing , virology .
Randamisation and Allocation :
Patients will be given aclosed envelope containing either letter C or letter I . The envelope that opened by patient will not change allocation .
The enrolled cases will be allocated into two groups with 1:1 allocation. Group 1 :( Study group ) include cases that will undergo bilateral internal iliac arteries ligation .
Group II :( Control group ) will undergo conservative management by three step technique (Shehata's technique) .
Intervention
Preoperative preparation :
Planned elective CS ≤ 37 wk unless the clinical situations necessitate earlier termination of pregnancy.
A multidisciplinary team including a two senior obstetricians, vascular surgeon , a urologist, an anesthesiologist, and a pediatrician are involved in the operation.
Four units of cross-matched blood are prepared for each patient .Ureteric catheters will be prepared to be used when indicated . Drugs that control bleeding will be preparedsuch as Oxytocin, Carbetocin, Ergometrine, Misoprostol and Tranexamic acid.
All cases undergo general anesthesia by a specialized team. The operation started with Pfannenstiel skin incision and careful dissection of urinary bladder till exposing the uterus.
Uterine incision above placental edge will be done to avoid transplacental incision that triggers heavy bleeding and then extraction of the baby with ecbolic administration, the uterus with the placenta inside will be exteriorized outside the abdomen .Redissecion of U.B will be done if previous dissection at the beginning of the surgery is insuffient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Ligation of the bilateral internal iliac arteriesConservative management of PAS with Ligation of the bilateral internal iliac arteries |
| Control group | Active comparator | Procedure: Shehat's techniqueConservative treatment with Shehata's technique and no internal iliac ligation |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age under 35 years old.
- Prenatally diagnosed placenta accreta .
- Planned caesarean section ≤ 37 wks .
- ≤ previous 3 ceserian sections .
- Placenta accretta spectrum grade 1 , 2 ,3 .
Key exclusion criteria (5 listed)
- Cases with high risk of intraoperative blood loss as hemorrhagic disorders and thrombocytopenia .
- Cases on anticoagulant therapy.
- Patients who completed her family.
- Hemodynamicaly unstable patients.
- Finally cases who refused 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 |
|---|---|---|
| Ligation of the bilateral internal iliac arteriesopening the posterior peritoneum overlying the bifurcation of the common iliac arteries. Then careful dissection of the internal iliac artery is carried out on each side and the anterior division of the internal iliac artery is ligated 4 cm below the bifurcation of the common iliac on both sides by single ligation procedure using Vicryl 1.0 . Re-checking of the femoral pulsation of both sides is performed. Then, the placenta is removed manually in a piecemeal manner, any remaining bleeding points from the placental site are then controlled by hemostatic sutures . | Procedure or surgery | Study group |
| Shehat's techniqueThe three-step technique (Shehata's technique) entailed 3 steps, the first step is double bilateral ligation of uterine arteries before placental separation. Uterine artery ligation is made at 2 levels. First will be done at the isthmus and second will be done 1 cm above the cesarean incision. Regarding timing of ligation , we will apply the uterine artery ligation before placental separation to minimize blood loss at the attempt of placental separation. Placenta is separated manually either totally or in piecemeal. If manual separation failed, placenta is removed by scissors. Application of quadruple sutures is done at the lower uterine segment to compress and secure the neovascularization in the bed of placenta. Insertion of triple way catheter is commenced from inside the uterine incision downwards using long artery forceps or uterine sound and the pulled by the assistant from below. The catheter balloon is inflated by 50 cc saline and left for 48 hours | Procedure or surgery | Control group |
Primary outcome
Intraoperative blood loss
Time frame: 6 months
the volume of blood collected in the suction apparatus, excluding the volume of liquor collected, this will be done by meticulous recording of the blood volume in the suction apparatus before opening the uterus and then calculating the exactly added amount of liquor, so that it becomes excluded from the calculation) to the calculated volume of blood obtained from the pre and postoperative difference in weight of the towels and drapes placed beneath the patients, using the following formula: (WET Item Gram Weight - DRY Item Gram Weight¼milliliters of blood within the item) .
Cesarean hysterectomy rate
Time frame: 6 months
The success of procedure in prevention of hysterectomy
2 secondary outcomes
Operative time
Time frame: intraoperative
Operative and postoperative complications
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: Yes. On valuable request
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ligation of the bilateral internal iliac arteries and Shehat's technique in people with Placenta Accreta and Cesarean Hysterectomy, run by Tanta 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 7 inclusion and 5 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 28 Feb 2024. 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 Ayman Dawood, MD (+201020972067, ayman.dawood@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative blood loss (time frame: 6 months). 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 28 Feb 2024.