Plasma Concentration of Biological Markers in Placenta Accreta Spectrum

Placenta Accreta Clinical Trial

Official title:

Plasma Concentration of Biological Markers in Placenta Spectrum

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04525534
• Other study ID #: 261299
• Status: Terminated
• Start date: August 30, 2020
• Est. completion date: July 10, 2023

Study information

• Verified date: November 2023
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: July 10, 2023
• Est. primary completion date: July 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Placenta Accreta
• Placenta Diseases

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the level of placental-derived MPs (Microparticles/mL)	Determine quantitatively the level of placental-derived MPs which may be altered in 10 subjects with PAS and 10 phenotypically-matched controls.	Up to 6 hours
Primary	Identify biomarkers (picogram/mL)	Determine quantitatively the level of biomarkers which may be altered in 10 subjects with PAS and 10 phenotypically-matched controls.	Up to 6 hours
Secondary	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.	Examine the correlation between maternal serum total placental MPs and biomarkers to the FIGO classification	Up to 6 hours