Paracervical Pouch in Placenta Accreta Spectrum

Study Overview
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Brief Summary
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The study objective is the significance of the ultrasound detection of the paracervical pouch in placenta accreta spectrum. It aimed to evaluate its relation to the degree of placenta accreta spectrum, amount of the blood loss and the number of packed red blood cells transfused.

Detailed Description
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The study will be carried on patients diagnosed with placenta previa or placenta accreta spectrum and had at least one caesarean section. The study will be divided into 2 groups of 70 patients at least per each. The first group will include patients in whom a paracervical pouch is detected, and the second group will include patients in whom the pouch is not detected by transvaginal ultrasound. paracervical pouch is defined ultrasonographic as the downward displacement of the uterine serosa from the level of the cervical internal os

Official Title
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Paracervical Pouch Significance in Placenta Accreta Spectrum

Conditions
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Placenta Accreta

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Patients between 19 to 40 years old Patients had at least one cesarean section. Exclusion Criteria: • Patients who request hysterectomy. Patients diagnosed with hepatitis B, C, or HIV, Those with bleeding diathesis. Patients whose BMI is more than 40 kg/m2. Patients who need an emergency cesarean section.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| positive paracervical pouch<br>The first group will include patients in whom a paracervical pouch is detected by transvaginal ultrasound. | |
| negative paracervical pouch<br>the second group will include patients in whom the pouch is not detected by transvaginal ultrasound | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of intraoperative diagnosis of placenta accreta spectrum | the number of patients diagnosed intraoperatively with placenta accreta spectrum according to international federation of obstetrics and gynecology in both groups. | intraoperative | 
| calculated amount of blood loss | the total amount blood lost intraoperatively in millilitres. | intraoperative and 24 hours postoperative | 
| blood transfusion | the amount of packed red blood cell, fresh frozen plasma and platelets transfused in both groups. | intraoperative and 24 hours postoperative | 
| rate of hysterectomy | the percentage of cases had hysterectomy in both groups. | intraoperative till 40 days postoperative | 
| internal iliac artery ligation | the rate of internal iliac artery ligation in both groups. | intraoperative | 
| Intensive care unit admission | the number of patients admitted to the intensive care unit and the duration of their stay. | postoperative for 5 days | 
| hospital stays | the duration of hospital stays after the operation. | postoperative for 1 month | 
| the presence of intraoperative pouch | the detection of an intraoperative paracervical pouch grossly. | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total operation time | the duration from the skin incision till skin closure. | intraoperative | 
| repair time | the duration from the placental separation till closure of the first layer. | intraoperative | 
| preoperative hemoglobin levels in gm/dl | the amount of the hemoglobin measured in gm/dl before the operation in both groups. | 24 hours before the operation | 
| postoperative hemoglobin levels in gm/dl | the amount of the hemoglobin measured in gm/dl after the operation in both groups. | 6 hours postoperative | 
| rate of uterine wall disruption | the number of patients who have a disruption of their anterior uterine wall during bladder dissection or placental separation in both groups. | intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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placenta adherence