Placenta Accreta Spectrum Protocol

May 8, 2020 updated by: Sherif Abdelkarim Mohammed Shazly, Assiut University

Placenta Accreta Spectrum International Database (PAS-ID): Project Protocol

Aim of this project is to study diagnosis and management approaches of PAS and to assess safety and efficacy of different conservative approaches compared to planned hysterectomy. We aim at improving selection process and patient counselling for women who would like to consider alternatives to hysterectomy. To achieve these objectives, creation of an international database collected by PAS-experienced centers that represent all continents would promote conduction of large studies that provide higher level of evidence on different options of management of PAS

Study Overview

Detailed Description

Placenta accreta spectrum (PAS) is a complex placentation disorder associated with high maternal morbidity; complications of PAS include hemorrhage, blood transfusion, multiple organ failure, and death

  • The incidence of PAS has been increasing steadily in response to the increase in cesarean delivery rate
  • Available evidence supports planned preterm cesarean hysterectomy with the placenta left in situ as the standard treatment of PAS

However, hysterectomy is traumatic to many women due to its operative sequences, impact on fertility, and disruption of self-image. Therefore, several conservative management options were proposed as an alternative to hysterectomy

  • Although many of conservative approaches yielded satisfactory results, their implementation as a part of standard protocols has been limited
  • There is primarily because evidence supporting most of these approaches is limited to case series, which is insufficient to support their safety. As a sequence, clinical trials are challenged by the lack of the margin of safety that would support ethical rationale of future studies. Availability of large multicenter studies is anticipated to provide robust evidence regarding optimal management of PAS and appropriate patient selection for conservative management

Study Type

Observational

Enrollment (Anticipated)

1500

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 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

18 years to 48 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women diagnosed with placenta accreta spectrum (PAS) and managed in the recuriting hospitals between 2010 and 2020, who met study selection criteria

Description

Inclusion Criteria:

  • Pregnant women diagnosed with PAS, aged between 18 to 48 years.
  • Women should be delivered by the corresponding center.

Exclusion Criteria:

  • Inadequate follow-up
  • Authorization to use anonymous patient data for research purposes.

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
Patients with placenta accreta spectrum (PAS)
This cohort presents patients who were suspected or diagnosed either antenatal or intrapartum with placenta accreta spectrum
This procedure refers to planned delivery of the fetus through Cesarean incision, leaving the placenta in situ and proceeding with hysterectomy
This term describes a single or combined intervention of uterine artery ligation, internal iliac artery ligation, prophylactic balloon placement in the aorta or internal iliac artery, uterine artery embolization, compression sutures, or excision and reconstruction of uterine wall

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure of conservative management of placenta accreta spectrum (PAS)
Time Frame: from delivery to 6 months after delivery
Need for emergency or delayed hysterectomy following trial of conservative treatment
from delivery to 6 months after delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal blood loss
Time Frame: From delivery and up to 24 hours postpartum
Estimation of blood loss during Cesarean section in ml
From delivery and up to 24 hours postpartum
Incidence of urinary injury during intraoperative management of placenta accreta spectrum (PAS)
Time Frame: From delivery and up to 6 weeks postpartum
Incidence of urinary bladder and/or ureteric injury
From delivery and up to 6 weeks postpartum
Admission to maternal intensive care unit (ICU) after management of placenta accreta spectrum (PAS)
Time Frame: From delivery and up to 6 weeks postpartum
Admission to ICU due to maternal instability
From delivery and up to 6 weeks postpartum
Infectious morbidity after management of placenta accreta spectrum (PAS)
Time Frame: From delivery and up to 6 weeks postpartum
Incidence of sepsis and septic shock following interventions to manage PAS
From delivery and up to 6 weeks postpartum

Collaborators and Investigators

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

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.

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, 2020

Primary Completion (Anticipated)

August 31, 2020

Study Completion (Anticipated)

November 1, 2020

Study Registration Dates

First Submitted

May 8, 2020

First Submitted That Met QC Criteria

May 8, 2020

First Posted (Actual)

May 12, 2020

Study Record Updates

Last Update Posted (Actual)

May 12, 2020

Last Update Submitted That Met QC Criteria

May 8, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • PAS-ID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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