NCT05307016

Morbidly Adherent Placenta, Diagnosis and Proper Management

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Sohag University · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Morbidly Adherent Placenta

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Two dimensional ultrasonography power and color doppler	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.

Timeline

• Start date: 2022-02-01
• Primary completion: 2023-02-01
• Completion: 2023-05-01
• First posted: 2022-04-01
• Last updated: 2022-04-01

Locations

1 site across 1 country: Egypt