Placenta Accreta Spectrum Disorder Conservative Managment Versus Hysterectomy Prospective Analysis

November 3, 2023 updated by: Nourhan Elsadany

The aim of this study is to identify risk factors associated with performing cesarean hysterectomy versus conservative management in patients with placenta accreta spectrum (PAS).

Research question What are the risk factors associated with cesarean hysterectomy in patients with placenta accreta spectrum? Research hypothesis There are certain risk factors associated with cesarean hysterectomy in patients with Placenta accreta spectrum (PAS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Placenta accreta spectrum disorder (PAS) is a serious obstetric disorder that is characterized by low lying and deep penetration of the villi which are abnormally attached to the myometrium of the uterus. This obstructs its complete separation during the third stage of labor which induces continued bleeding, and have potentially life- threatening for the mother. Most commonly, it is a consequence of a partial or complete absence of the compact and spongy layer known as the decidua basalis, and mis-development of the fibrinoid Nitabuch's layer which lies between the boundary zone of the thick endometrium and the cytotrophoblastic shell in the placenta.

Traditionally, caesarean hysterectomy at the time of delivery has been the preferred management strategy for placenta previa accreta. Not only does this approach preclude future fertility, but it is also a procedure synonymous with significant perioperative risks. For women who wish to conserve their reproductive function, other treatment options have been described.

1.INTRODUCTION/ REVIEW Placenta accreta is defined as "the abnormal localization and adherence of the placenta villi to the uterine myometrium. Patients at risk for abnormal placentation should be assessed antenally by ultrasonography, with or without adjunct magnetic resonance imaging if indicated . Various grading systems of villous invasion during placenta implantation are integrated to a spectrum (PAS), including placenta accreta (the villi invade superficially into the myometrium), increta (the villi invade deeper into the myometrium but do not reach the serosa), and percreta (the villi invade into the uterine serosa or adjacent organs) Clinically, severe complications of PA include severe obstetric hemorrhage leading to disseminated intravascular coagulopathy (DIC), iatrogenic injury to the ureters, bladder, bowel, respiratory distress syndrome (RDS), acute transfusion reactions, electrolyte imbalance, and renal failure. In women with PA, the expected blood loss at delivery is 3000- 5000 mL, About 90% of patients require a blood transfusion with 40% requiring more than ten units of packed cell transfusion .

The most difficult problem to deal with is controlling hemorrhage during delivery caused by PAS disorders. The potential for bleeding correlates with the degree to which the placenta invades the myometrium, the area of abnormal adherence involved, and the presence or absence of invasion into extrauterine tissues such as the bladder or parametrial tissues .

Different methods have been employed to manage the PA, ranging from uterine conservation, which involves leaving the placenta in situ, to conventional hysterectomy. Classical cesarean sections (C- sections) prevent the excessive bleeding by leaving the adherent placenta in situ and by adopting strategic planning with a comprehensive analysis that aids the reduction in maternal morbidity and mortality rates .

Perinatal emergency hysterectomy is routinely used to avoid maternal morbidity and mortality . Given the fact that cesarean section history and placenta previa are major risk factors, the incidence of PAS disorders increases with the increasing rate of cesarean section .

Other risk factors include spontaneous or induced abortion, repeated miscarriages, in vitro fertilization embryo transfer, advanced maternal age, history of endometrial ablation, and previous uterine surgery .

Conservative and non-conservative management for PAS disorders have been compared. Cesarean hysterectomy is regarded as the safest and most practical, thereby remaining the management option of choice. Nevertheless, hysterectomy is associated with high rates of severe maternal morbidity. In cases of placenta percreta, especially with bladder invasion, owing to damage to pelvic organs and vasculature during hysterectomy .In recent years, with the application of an abdominal artery balloon and the improvement of surgical techniques, efforts are made to preserve the uterus for patients PAS. This is not only the improvement for fertility preservation, but also for better control of bleeding to reduce maternal morbidity.

The evidence on conservative management is considered low-quality, less reproducible, and operator-dependent. Critics noted the lack of histopathological confirmation or detailed differential diagnosis. Confounding factors in these studies needs to be controlled including the application of interventional techniques, the severity of placental invasion, and various placental positions and suture techniques .

Therefore, investigators will undertake a prospective study to analyze maternal and neonatal outcomes comparing women with PAS disorders treated with cesarean hysterectomy or conservatively.

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

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

Study Locations

  • Egypt
      • Giza, Egypt, 267138
        • Nourhan Abdelhady Soliman Elsadany

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

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The aim of this study is to identify risk factors associated with performing cesarean hysterectomy versus conservative management in patients with placenta accreta spectrum (PAS).

Description

Inclusion Criteria:

  • Pregnant women with history of previous cesarean section.
  • Age above 18 years.
  • Gestational age above 28 weeks.
  • Confirmed diagnosis of Placenta previa accreta spectrum disorder by U/S or MRI if needed.
  • U/S signs suggestive of placenta previa accrete (Green-top Guideline).

Exclusion Criteria:

  • Gestational age less than 28 weeks.
  • Age less than 18years

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
Intervention / Treatment
Conservative management
150 patients
Procedure: interventional techniques, the severity of placental invasion, and various placental positions and suture techniques
Clinically, severe complications of PA include severe obstetric hemorrhage leading to disseminated intravascular coagulopathy (DIC), iatrogenic injury to the ureters, bladder, bowel, respiratory distress syndrome (RDS), acute transfusion reactions, electrolyte imbalance, and renal failure. In women with PA, the expected blood loss at delivery is 3000- 5000 mL, About 90% of patients require a blood transfusion with 40% requiring more than ten units of packed cell transfusion
CS hysterectomy
150 patients
Procedure: interventional techniques, the severity of placental invasion, and various placental positions and suture techniques
Clinically, severe complications of PA include severe obstetric hemorrhage leading to disseminated intravascular coagulopathy (DIC), iatrogenic injury to the ureters, bladder, bowel, respiratory distress syndrome (RDS), acute transfusion reactions, electrolyte imbalance, and renal failure. In women with PA, the expected blood loss at delivery is 3000- 5000 mL, About 90% of patients require a blood transfusion with 40% requiring more than ten units of packed cell transfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of the patient who diagnosed intraoperative with placenta accreta spectrum disorder and undergoing conservative management or hysterectomy
Time Frame: from time of operation to diagnoses 1week
The diagnoses will be made based on intra-operative findings and/or pathologic features depending on the degree of placenta invasion (invading the myometrium or invading up to or beyond the uterine serosa). Patients with placenta accreta with complete peri-operative information will be included for further analysis.
from time of operation to diagnoses 1week

Collaborators and Investigators

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

Sponsor

Nourhan Elsadany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 1, 2022

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

May 11, 2022

First Submitted That Met QC Criteria

October 23, 2023

First Posted (Actual)

October 27, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 3, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS 714/2021

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.

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