Morbidly Adherent Placenta, Diagnosis and Proper Management

Study Overview
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Brief Summary
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The main idea of this study is to establish the diagnostic criteria for cases of morbidly adherent placenta (MAP) using different ultrasonographic modalities and compare this with intra-operative findings and postoperative histopathological assessment

Detailed Description
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This study is a clinical trial that will include all patients fulfilling the eligibility criteria and presented to the emergency unit of the department of Obstetrics and Gynecology in Sohag University hospital (Egyptian tertiary referral hospital) between February 2022 and February 2023. The attending physician will explain the nature of the study and all patients will be asked to sign an informed consent. A senior physician will evaluate the patient to confirm the diagnosis of placenta previa and degree of invasion in query accreta patients by using transabdominal and transvaginal US (Voluson,p8). 2D gray scale ultrasound, color and power doppler ultrasound will be performed firstly followed by 3D ultrasound. All data will be saved in closed excel sheet and patients will be operated by a different surgical team, intraoperative staging of degree of placental invasion will be done according to clinical grading system by Collins et al., 2015 [5] in addition to histopathological evaluation when available, such as in cases of hysterectomy and cases with anterior placenta who were treated by excision of part of anterior uterine wall suitable for histopathological evaluation.

Official Title
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Dilemma of the Appropriate Surgical Intervention of Morbidly Adherent Placenta: Could it be Solved Prenatally?

Conditions
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Morbidly Adherent Placenta

Intervention / Treatment
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* Diagnostic Test: Two dimensional ultrasonography power and color doppler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: o All pregnancies complicated with any degree of Placenta previa anterior, posterior or centralis undergoing pre-labor CS at gestational age (36+0 to 40+0), patients will be divided into subgroups according to number of previous CS, presence or absence of antepartum hemorrhage and qualifications of operative theatre in previous deliveries (public or private sector). Exclusion Criteria: Women with history of medical co-morbidities such as chronic hypertension, Diabetes mellitus, renal diseases, autoimmune diseases, history of organ transplantation and immunosuppressive therapy, hematological diseases, history of thrombotic events, cardiopulmonary diseases, liver diseases Acute and chronic inflammatory diseases. Pregnancy induced medical disorders like: Gestational hypertension, preeclampsia, Gestational diabetes, Gestational thrombocytopenia and proteinuria. Fetal anomalies. Emergency CS if the patient is in labor.
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 |
| --- | --- |
| MAP patients<br>All pregnancies complicated with any degree of Placenta previa anterior, posterior or centralis undergoing pre-labor CS at gestational age (36+0 to 40+0) | Diagnostic Test: Two dimensional ultrasonography power and color doppler<br>* transabdominal and transvaginal two-dimensional power Doppler ultrasound volumes of the placental bed were obtained according to a predefined protocol with the participant in a semi-recumbent position and a full bladder using a RAB4-8-D 3D/4D curved array abdominal transducer (4-8.5 MHz) on a Voluson E8. Predetermined machine settings were used. To allow for differences in attenuation of the power Doppler signal resulting from variation in placental site and maternal adiposity. Intraoperative staging of degree of placental invasion will be done according to clinical grading system by Collins et al., 2015. Specimens obtained from patients who underwent hysterectomy or resection of segment of anterior uterine wall in cases with anterior placenta previa will be immersed in formalin 10% concentration and will be sent for histopathological evaluation that will be done by the same pathologist.<br>* Other names: postoperative histopathological assessment of available specimens;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acurray of ultrasonographic features for diagnosis of different degrees of MAP | The sensitivity and specificity of the ultrasonographic findings of MAP according to the final intraoperative diagnosis and available histopathological data | All pregnancies complicated by any degree of placenta previa undergoing pre-labor CS at gestational age (36+0 to 40+0) weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The validity of ultrasonographic findings of MAP for selecting the appropriate surgical intervention |  | All pregnancies complicated by any degree of placenta previa undergoing pre-labor CS at gestational age (36+0 to 40+0) weeks | 
| Evaluating the accuracy of this criteria in all types of placenta previa |  | All pregnancies complicated by any degree of placenta previa undergoing pre-labor CS at gestational age (36+0 to 40+0) weeks | 
| Studying all factors that may affect the accuracy of this criteria such as number of previous CS, qualifications of the previous CS, presence or absence of antepartum hemorrhage. |  | All pregnancies complicated by any degree of placenta previa undergoing pre-labor CS at gestational age (36+0 to 40+0) weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultrasonography, Intraoperative staging, Histopathological assessment