MRI for the Diagnosis of Placenta Accreta Spectrum

NCT04151979 | Unknown

• 1 other identifier: PAS001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Placenta Accreta

Keywords

placenta accreta spectrum; MRI; score scale; diagnosis

Outcome Measures

Primary Outcomes (1)

• Rate of PAS diagnosed

  diagnose as PAS through clinical observation or specimen pathology after surgery

  one week after surgery

Secondary Outcomes (4)

• Blood loss volume(ml)

  24 hours after surgery

• Rate of hysterectomy

  two weeks after surgery

• Rate of preterm labor

  two weeks after surgery

• Blood transfusion volume(ml)

  two weeks after surgery

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients who didn't undergo MRI
• Patients who didn't deliver the baby in PUTH -

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Placenta Accreta; Disease

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• YangYu Zhao, MD

  Peking University Third Hospital

  STUDY DIRECTOR

Central Study Contacts

Lian Chen

CONTACT

+8613811748746; bysychenlian@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: November 5, 2019
• Study Start: January 1, 2015
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: November 5, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)