The Application of Comprehensive Prevention and Treatment Strategy of Placenta Accreta Spectrum Disorders

NCT06477497 | Not Yet Recruiting

• 1 other identifier: 2022YFC2704505
• Study Type: observational
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

Placenta accreta spectrum (PAS) disorders are pathological attachment of the placenta to myometrium, where trophoblastic cells invade the uterine placental interface. PAS can lead to severe postpartum hemorrhage or even maternal death. Prenatal diagnosis of PAS is essential for optimal obstetric management to improve the pregnancy outcomes. However, in some low resource regions in China, less than 20% PAS are detected before delivery. To explore the feasibility and universality of the bundled prevention and treatment strategy for placenta accreta spectrum disorders in different levels of medical institutions, and to investigate its effectiveness in improving the specialized disease management capabilities of medical institutions at all levels. We will conduct a regional, cluster-randomized trial to assess a multicomponent PAS management strategy to improve the prepartum detection rate of PAS.

Conditions

Placenta Accreta Spectrum

Keywords

placenta accreta spectrum disorders

Outcome Measures

Primary Outcomes (1)

• antepartum diagnosis rate of PAS

  through study completion, an average of 1.5 year

Study Arms (2)

study group

Theoretical training, technical supporting and standardized referral process

control group

usual care

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant women with placenta accreta spectrum disorders

You may qualify if:

• Pregnant women who have regular prenatal examination at the research hospitals
• Pregnant women diagnosed with PAS before or after delivery

You may not qualify if:

• Pregnant women who have never been diagnosed with placental implantation disease throughout the pregnancy
• Pregnant women who were lost to follow-up during the study period

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• National Key Research and Development Program of China: collaborator

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Central Study Contacts

Jinsong Gao

CONTACT

0861069156225; gaojingsong@pumch.cn

Study Design

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

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 27, 2024
• Study Start: July 1, 2024
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: June 27, 2024

Record last verified: 2024-06