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

Sponsor
Sohag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05510076
Collaborator
(none)
60
1
10.9
5.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Different Surgical Approaches Used for Conservative Management of Placenta Accreta Spectrum in Sohag University Hospital
    Actual Study Start Date :
    Aug 1, 2022
    Anticipated Primary Completion Date :
    Jun 30, 2023
    Anticipated Study Completion Date :
    Jun 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. successful intervention procedure [1 day]

      Preservation of the uterus

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 51 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sohag University Sohag Egypt

    Sponsors and Collaborators

    • Sohag University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abdallah Ahmed Refaat, mr., Sohag University
    ClinicalTrials.gov Identifier:
    NCT05510076
    Other Study ID Numbers:
    • Soh-Med-22-08-03
    First Posted:
    Aug 22, 2022
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 22, 2022