Plasma Concentration of Biological Markers in Placenta Accreta Spectrum

Terminated

• Conditions: Placenta Diseases; Placenta Accreta

• Registration Number: NCT04525534
• Lead Sponsor: University of Arkansas

Brief Summary

The purpose of this exploratory study is to determine how well maternal serum biomarkers and placental micro-particles (MP) correlate with placenta accreta spectrum (PAS) at the time of cesarean delivery in women with suspected PAS compared to women without PAS. Our aim is to determine if women with PAS have a unique MP and protein signature at the time of delivery compared with women without PAS.

Detailed Description

Maternal blood samples will be taken at various points during the intrapartum period. A healthy group of women admitted for delivery will act as a matched control and will have their blood sampled at similar time points. The primary outcome variables will include the total number of micro-particles, the number of micro-particles from each cell line (platelet, placental, endothelial etc.), and protein markers The knowledge gained from this study has the potential to develop a diagnostic test for PAS with the ability to improve management and outcomes for mother and baby through earlier diagnosis.

Study Timeline

• Study First Submitted: 2020-08-20
• Study First Submitted QC: 2020-08-20
• Study First Posted: 2020-08-25
• Study Start: 2020-08-30
• Primary Completion: 2023-07-10
• Study Completion: 2023-07-10
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 19

Inclusion Criteria

• Age 18 - to 45-years old, inclusive
• Suspected or confirmed PAS or phenotypically matched controls
• Delivery by cesarean section
• Gestational age greater than 28 weeks
• Singleton pregnancy

Exclusion Criteria

• Intrauterine fetal demise,
• Severe fetal anomalies (infant not expected to survive)
• Emergent cesarean delivery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine the level of placental-derived MPs (Microparticles/mL)	Up to 6 hours	Determine quantitatively the level of placental-derived MPs which may be altered in 10 subjects with PAS and 10 phenotypically-matched controls.
Identify biomarkers (picogram/mL)	Up to 6 hours	Determine quantitatively the level of biomarkers which may be altered in 10 subjects with PAS and 10 phenotypically-matched controls.

Secondary Outcome Measures

Name	Time	Method
Is there a correlation between maternal serum total placental MPs and biomarkers to the International Federation of Gynecology and Obstetrics (FIGO) classification for PAS at the time of cesarean delivery.	Up to 6 hours	Examine the correlation between maternal serum total placental MPs and biomarkers to the FIGO classification