New Conservative Technique for Placenta Accreta Spectrum

Study Overview
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Brief Summary
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participants diagnosed as placenta accreta spectrum were subjected to cesarean delivery. Investigators manually detected a plan of cleavage through which the placenta was separated followed by closure of defective placental bed. Data were collected about the outcome.

Detailed Description
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Demographic data, detailed history taking, routine blood tests were done. Trans-abdominal and trans-vaginal ultrasound to diagnose placenta accreta spectrum ( PAS). Detecting new signs to help sure diagnosis of PAS. Cesarean section will be performed through extended transverse supra-pubic incision bladder dissection from anterior uterine wall using electro-coagulation instruments and double ligation of large caliber bridging vessels. Uterine incision above the placental bulge by at least 5 mm then complete separation of the placenta starting from least resistance plans to high resistant one leaving a clear defect which will be closed by running sutures from inside the uterus and controlling placental bed hemorrhage then closing the uterine incision with compressing the bed from outwards ( double compression sutures ) internal Iliac artery ligation may be done as a complementary measure to control the bleeding from abnormal pelvic vasculature, insertion of intraperitoneal drain and closure of abdominal wall in layers.

Official Title
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Placenta Accreta; A Vision for Conservative Surgery

Conditions
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Placenta Accreta Spectrum

Intervention / Treatment
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* Diagnostic Test: ultrasound
* Procedure: closure of uterine wall defect


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnant women diagnosed as placenta accreta spectrum with previous Cesarean section, with or without other uterine surgeries and less than 40 years of age. Exclusion Criteria: pregnant women having medical conditions such as cardiac diseases, coagulopathy and hematological disorders. pregnant women had 5 or more previous Cesarean sections or their age more than 40 years

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Investigators conducting prospective study for management of placenta accreta spectrum including diagnosis and uterine sparing surgery.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pregnant women with placenta accreta spectrum<br>The participants were subjected to ultrasound to diagnose placenta accreta spectrum followed by new conservative surgical technique. | Diagnostic Test: ultrasound<br>* trans-vaginal and trans-abdominal ultrasound using different modalities such as grey-scale, Doppler, multi-planer mode<br>Procedure: closure of uterine wall defect<br>* uterine incision above placental bulge by at least 5 mm then complete separation of the placenta starting from areas of least resistance to areas of high resistance leaving a clear defect which will be closed by non locked running sutures from inside the uterus starting from one edge, hitch the bed to the other edge of the defect and controlling placental bed hemorrhage then closing the uterine incision via running sutures in 2 layers with compressing the bed from outwards in the first layer. hemostasis of the abnormal pelvic vasculature if excessive bleeding internal iliac artery may be ligated then insertion of intra-peritoneal drain followed by closing the abdomen.<br>* Other names: Double compression suture;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical outcome | number of participants whom their uterus were preserved without major hemorrhage | from the time of the surgery until 48 hours after. | 
| intra-operative blood loss | the amount of blood loss during operation was estimated for each participant. | intraoperative | 
| surgical complications | number of participants had bladder, ureter injury or hysterectomy, | intraoperative | 
| internal iliac artery ligation | number of participants had with either unilateral or bilateral internal iliac artery ligation | intra-operative | 
| high dependency unit admission | number of participants needed high dependency unit admission | from 0 to 48 hours postoperative | 
| wound complications | number of patients suffered wound infection | up to 2 weeks postoperative | 
| change in the hemoglobin level | participant's hemoglobin was measured | from 48 hours pre operative to 48 hours post operative | 
| blood transfusion | number of units of blood and it's products transfused to participants | from 48 hours preoperative to 48 hours postoperative. | 
| hematuria | number of participants suffered hematuria | post-operative up to 24 hours | 
| manual cervical assesment | participants were subjected to vaginal examination to asses the cervix lenght | before skin incision | 
| placental separation | number of participants whom their placenta was separated manually | intra-operative | 
| surgical grading of the placenta | number of participants who had accreta, increta, percreta or mixed type | intra-operative | 
| ultrasound grading of the placenta | number of participants who were diagnosed by ultrasound as accreta, increta or percreta | pre-operative | 
| manual assessment of vaginal fornices | participants were subjected to vaginal examination to assess fornices | before skin incision | 
| repair time | the time recorded from the end of the placental separation to the closure of the first layer of the uterus | intra-operative | 
| total operation time | the time taken from the start of the skin incision to the skin closure | intra-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| placental bed | number of participants that investigators detected a well delineated placental bed like a pouch | intra-operative | 
| pouch site | the site of the pouch in relation to the cervix | intra-operative | 
| defect site | the location of the myometrium defects | intra-operative |