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

NCT05510076 | Unknown

• 1 other identifier: Soh-Med-22-08-03
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Placenta Accreta Spectrum

Outcome Measures

Primary Outcomes (2)

• successful intervention procedure

  Preservation of the uterus

  1 day

• maternal mortality and morbidity

  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

  6 weeks

Study Arms (3)

Group A

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

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

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

Eligibility Criteria

• Age: Up to 51 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

community sample, any suspected case of PAS disorders.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, Egypt

RECRUITING

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Central Study Contacts

AbdAllah Refaat

CONTACT

+201141519467; abdallah.refaat@med.sohag.edu.eg

AbdAllah Refaat

CONTACT

+01555518179; abdoscopy@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: mr.

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 22, 2022
• Study Start: August 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 22, 2022

Record last verified: 2022-08

Locations

EG (1)