Morbidly Adherent Placenta, Diagnosis and Proper Management

• Conditions: Morbidly Adherent Placenta
• Interventions: Diagnostic Test: Two dimensional ultrasonography power and color doppler

• Registration Number: NCT05307016
• Lead Sponsor: Sohag University

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-02-01
• Status Verified: 2022-03
• Study First Submitted: 2022-03-23
• Study First Submitted QC: 2022-03-23
• Last Update Submitted: 2022-03-23
• Study First Posted: 2022-04-01
• Last Update Posted: 2022-04-01
• Primary Completion: 2023-02-01
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MAP patients	Two dimensional ultrasonography power and color doppler	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)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Sohag University, Medical school; 🇪🇬 Sohag, Egypt