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

August 18, 2022 updated by: Abdallah Ahmed Refaat, Sohag University
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 51 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

community sample, any suspected case of PAS disorders.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
successful intervention procedure
Time Frame: 1 day
Preservation of the uterus
1 day
maternal mortality and morbidity
Time Frame: 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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

August 18, 2022

First Submitted That Met QC Criteria

August 18, 2022

First Posted (Actual)

August 22, 2022

Study Record Updates

Last Update Posted (Actual)

August 22, 2022

Last Update Submitted That Met QC Criteria

August 18, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-22-08-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Placenta Accreta Spectrum

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe