Evaluation of Different Surgical Approaches Used for Conservative Management of Placenta Accreta Spectrum in Sohag University Hospital

• Conditions: Placenta Accreta Spectrum

• Registration Number: NCT05510076
• Lead Sponsor: Sohag University

Brief Summary

The objective of this study is to evaluate different intra-operative procedures to control bleeding in cases of PAS disorders aiming to determine the best procedure regarding maternal morbidity and mortality post-operatively, and to evaluate the long-term effects of conservative management of PAS disorders.

Detailed Description

The term "placenta accreta spectrum" (PAS), formerly known as "morbidly adherent placenta" or "abnormally invasive placenta," refers to the aberrant trophoblast invasion of all or a portion of the placenta into the myometrium of the uterus. according to the depth of the villous invasion into the myometrium, the spectrum is assorted into three groups: placenta accreta (villi attach to the myometrium without invading it), placenta increta (villi infiltrate the myometrium), and placenta percreta (villi pierce through the uterine serosa and may infiltrate the surrounding tissues). The optimal strategy for managing PAS disorders remains debatable. Conservative management of PAS disorders includes all techniques aimed at preserving the uterus. Because intraoperative bleeding from PAS disorders is frequently massive and dramatic, causing severe maternal morbidity and mortality, it is essential to have a well-planned, effective, and rapid approach to this surgical challenge.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2022-08
• Study Start: 2022-08-01
• Study First Submitted: 2022-08-18
• Study First Submitted QC: 2022-08-18
• Last Update Submitted: 2022-08-18
• Study First Posted: 2022-08-22
• Last Update Posted: 2022-08-22
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Women with at least one previous caesarean section and suspected PAS disorders by imaging studies

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Exclusion Criteria

• Patients with intraoperative spontaneous placental separation.
• Patients with a preoperative diagnosis of placenta percreta who chose to have an elective hysterectomy.
• Any other associated uterine pathology requiring hysterectomy.
• Coagulation disorders.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
successful intervention procedure	1 day	Preservation of the uterus
maternal mortality and morbidity	6 weeks	ICU admission, need of re-exploration, drop of hemoglobin and hematocrit values, massive blood transfusion, bladder and/ or ureteric injury, coagulopathy, infection and hospital re-admission within 6 weeks

Trial Locations

Locations (1)

Sohag University; 🇪🇬 Sohag, Egypt