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

NCT ID: NCT05510076

Last Updated: 2022-08-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-06-30

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.

Conditions

Placenta Accreta Spectrum

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group A

in which full-thickness vertical compression suture combined with inflated intrauterine balloon are used to control bleeding

No interventions assigned to this group

Group B

in this group, a resective-reconstructive technique is used, which involves resecting the invasive accreta area followed by immediate uterine reconstruction and bladder reinforcement

No interventions assigned to this group

Group C

In this group, bilateral uterine artery ligations combined with cervical tamponade which is performed by elevating the cervix into the uterine cavity with Allis forceps, then suturing the anterior and/ or posterior cervical lip(s) into the anterior and/ or posterior uterine segment(s) depending on the site of bleeding with two or three simple interrupted stitches, with the patency of the cervical canal confirmed, followed by closure of the uterine incision

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

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.

• Maximum Eligible Age: 51 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Abdallah Ahmed Refaat

mr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag University

Sohag, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

AbdAllah Refaat

Role: CONTACT

abdallah.refaat@med.sohag.edu.eg

+201141519467

AbdAllah Refaat

Role: CONTACT

abdoscopy@gmail.com

+01555518179

Facility Contacts

AbdAllah Refaat

Role: primary

abdallah.refaat@med.sohag.edu.eg

+201141519467

Other Identifiers

Soh-Med-22-08-03

Identifier Type: -

Identifier Source: org_study_id