MRI for the Diagnosis of Placenta Accreta Spectrum

Placenta Accreta Clinical Trial

Official title:

MRI for the Diagnosis of Placenta Accreta Spectrum

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04151979
• Other study ID #: PAS001
• Status: Recruiting
• Start date: January 1, 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2019
• Source: Peking University Third Hospital
• Contact: Lian Chen
• Phone: +8613811748746
• Email: bysychenlian[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 -

Related Conditions & MeSH terms

• Placenta Accreta

Locations

Country	Name	City	State
China	Peking University Third Hospital	Peking	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of PAS diagnosed	diagnose as PAS through clinical observation or specimen pathology after surgery	one week after surgery
Secondary	Blood loss volume(ml)	The blood loss volume during the 24 hours after surgery	24 hours after surgery
Secondary	Rate of hysterectomy	Number of patients who were performed hysterectomy/Number of patients with PAS	two weeks after surgery
Secondary	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
Secondary	Blood transfusion volume(ml)	the volume of blood transfusion	two weeks after surgery