An interventional study of Ligation of the bilateral internal iliac arteries and Shehat's technique in Placenta Accreta, Cesarean Hysterectomy and Pelvic Devascularization, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-02-28.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
In the current study, the investigators aimed to compare the benefits of internal iliac ligation in placenta accreta spectrum
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:
Full history taking with special attention on:
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.
150 studies on the registry are indexed under Placenta Accreta; 40 are open to participants now.
This study's planned enrollment of 90 is above the median of 70 across 67 interventional studies indexed under Placenta Accreta.
Browse Placenta Accreta studies →Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Conservative management of PAS with Ligation of the bilateral internal iliac arteries
Procedure: Ligation of the bilateral internal iliac arteries
Conservative treatment with Shehata's technique and no internal iliac ligation
Procedure: Shehat's technique
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 .
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
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) .
Time frame: 6 months
Cesarean hysterectomy rate
The success of procedure in prevention of hysterectomy
Time frame: 6 months
Operative time
From skin to skin duration in minutes
Time frame: intraoperative
Operative and postoperative complications
Any operative organ injury
Time frame: 6 months
Plan to share: Yes — On valuable request
Supporting information: Study protocol, Statistical analysis plan
Time frame: 6 months
Access criteria: full acess
No publications or documents are linked to this record.
Started May 2022 (actual). Primary completion is estimated for Oct 2024, 29 months after the start.
Of 45 non-industry interventional studies with no phase under Placenta Accreta, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's planned 29 months is above that.
Counting every sponsor, half of 45 studies reached it within 19 months; a quarter within 12 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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