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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04525534
Other study ID # 261299
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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