## Protocol Section
### Identification Module
**NCT ID:** NCT04151979

**Brief Title:** MRI for the Diagnosis of Placenta Accreta Spectrum

**Official Title:** MRI for the Diagnosis of Placenta Accreta Spectrum

#### Organization Study ID Info
**ID:** PAS001
#### Organization
**Class:** OTHER
**Full Name:** Peking University Third Hospital
### Status Module
#### Completion Date
**Date:** 2019-12-31

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2019-11-05

**Type:** ACTUAL

**Last Update Submit Date:** 2019-11-01

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2019-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2015-01-01

**Type:** ACTUAL

**Status Verified Date:** 2019-10

#### Study First Post Date
**Date:** 2019-11-05
**Type:** ACTUAL
**Study First Submit Date:** 2019-10-24
**Study First Submit QC Date:** 2019-11-01
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Peking University Third Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** 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.

**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.

### Conditions Module

**Conditions:**

- Placenta Accreta

**Keywords:**

- placenta accreta spectrum

- MRI

- score scale

- diagnosis

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** diagnose as PAS through clinical observation or specimen pathology after surgery

**Measure:** Rate of PAS diagnosed

**Time Frame:** one week after surgery

#### Secondary Outcomes

**Description:** The blood loss volume during the 24 hours after surgery

**Measure:** Blood loss volume(ml)

**Time Frame:** 24 hours after surgery

**Description:** Number of patients who were performed hysterectomy/Number of patients with PAS

**Measure:** Rate of hysterectomy

**Time Frame:** two weeks after surgery

**Description:** The number of patients who delivered between 28 to 36+6 weeks/Number of patients with PAS

**Measure:** Rate of preterm labor

**Time Frame:** two weeks after surgery

**Description:** the volume of blood transfusion

**Measure:** Blood transfusion volume(ml)

**Time Frame:** two weeks after surgery

### Eligibility Module

**Eligibility Criteria:** 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 -

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** bysychenlian@126.com

**Name:** Lian Chen

**Phone:** +8613811748746

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Peking

**Contacts:**

***Contact 1:***

- **Email:** bysychenlian@126.com

- **Name:** Lian Chen

- **Phone:** +8613811748746

- **Role:** CONTACT

**Country:** China

**Facility:** Peking University Third Hospital

**State:** Beijing

**Status:** RECRUITING

**Zip:** 100191

#### Overall Officials

**Official 1:**

**Affiliation:** Peking University Third Hospital

**Name:** YangYu Zhao, MD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007744

- Term: Obstetric Labor Complications

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000010922

- Term: Placenta Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13811

- Name: Placenta Accreta

- Relevance: HIGH

- As Found: Placenta Accreta

- ID: M10764

- Name: Obstetric Labor Complications

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M13812

- Name: Placenta Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4583

- Name: Placenta Disorder

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010921

- Term: Placenta Accreta

### Misc Info Module

- Version Holder: 2024-05-24
