MRI for the Diagnosis of Placenta Accreta Spectrum

Placenta Accreta Spectrum (PAS) is a disease associated with abnormal placental adhesion and invasion. In recent years, the incidence of PAS has increased significantly, which can cause massive postpartum hemorrhage, hysterectomy,and even maternal mortality. The research team of Peking university third hospital developed the ultrasound rating scale in china at first to conduct preliminary assessment of the PAS risk which can identify the severity of cases. In a basis of ultrasound, plan to explore the MRI for the the investigators diagnosis of PAS according to some specific PAS features, like the the uneven signal intensity , the myometrial discontinuity, and black band on T2 image, and finally established a MRI scoring system of PAS. MRI score system of PAS can reduce the subjective difference of the clinician's visual reading, and assist the clinician to assess the risk of sever PAS further, and conduct perioperative preparation to reduce the risk of maternal morbidity and mortality to achieve a better clinical outcome.

Study Overview

• Status: Unknown
• Conditions: Placenta Accreta

Detailed Description

Placenta Accreta Spectrum (PAS) is a disease associated with abnormal placental adhesion and invasion. In recent years, the incidence of PAS has increased significantly, and the main risk is high hysterectomy rate,massive postpartum hemorrhage, and even maternal mortality in women at childbearing age. The research team of Peking university third hospital developed the ultrasound rating scale in china at first to conduct preliminary assessment of the PAS risk which can identify the severity of cases and guide the junior hospitals to transfer. Peking University third hospital is in the leading position in the preoperative diagnosis of PAS currently.

Magnetic resonance imaging (MRI) has become a common method for preoperative evaluation for sever cases. MRI can provide a map of the placenta and PAS features, like the uterus enlarged significantly, the uneven signal intensity , the myometrial discontinuity, and black band on T2 image. It has a high diagnostic value. At present, only Lim and Ueno reported MRI scoring system for PAS. Due to the small sample size and the limitation of the research methods, a widely applicable rating scale has not been established. MRI score system of PAS can reduce the subjective difference of the clinician's visual reading, and assist the clinician to assess the risk of sever PAS further, and conduct perioperative preparation to reduce the risk of maternal morbidity and mortality and achieve a better clinical outcome.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Lian Chen; Phone Number: +8613811748746; Email: bysychenlian@126.com

Study Locations

• China
  • Beijing
    • Peking, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital
      • Contact: Lian Chen; Phone Number: +8613811748746; Email: bysychenlian@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The patients who have risk factors of PAS, undergo "ultrasound scoring" and MRI ,finally delivered in Peking university third hospital.

Description

Inclusion Criteria:

1. Patients diagnosed as scarred uterus(with a history of cesarean section)
2. "ultrasound score" of PAS≥ 6 points who undergo MRI
3. Terminate pregnancy or childbirth in Peking university third hospital. -

Exclusion Criteria:

1. Patients who didn't undergo MRI
2. Patients who didn't deliver the baby in PUTH -

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of PAS diagnosed	diagnose as PAS through clinical observation or specimen pathology after surgery	one week after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss volume(ml)	The blood loss volume during the 24 hours after surgery	24 hours after surgery
Rate of hysterectomy	Number of patients who were performed hysterectomy/Number of patients with PAS	two weeks after surgery
Rate of preterm labor	The number of patients who delivered between 28 to 36+6 weeks/Number of patients with PAS	two weeks after surgery
Blood transfusion volume(ml)	the volume of blood transfusion	two weeks after surgery

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Director: YangYu Zhao, MD, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: October 24, 2019
• First Submitted That Met QC Criteria: November 1, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): November 5, 2019
• Last Update Submitted That Met QC Criteria: November 1, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: MRI; diagnosis; placenta accreta spectrum; score scale
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Placenta Accreta
• Other Study ID Numbers: PAS001

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
• product manufactured in and exported from the U.S.: No