Clinical trial NCT03782168: Plasma Concentration of Biological Markers in Placental Abruption
Official title: Plasma Concentration of Biological Markers in Placental Abruption
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Abruptio Placentae
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mother-infant dyads with suspected or confirmed diagnosis of placental abruption and healthy mother-infant dyads admitted for delivery.

Brief summary: This will be a prospective study conducted on women with a suspected/confirmed diagnosis of placental abruption. Maternal blood samples will be taken at various points during the peripartum 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 (specifically; placental growth factor (PlGF), soluble fms-like tyrosine kinase-1 (sFLT-1), vascular endothelial growth factor (VEGF), soluble endoglin (sEng)). Secondary outcomes if will examine the correlation between placental micro-particles, biomarkers, and extent of placental abruption.

Detailed description: The purpose of this study is to determine how well maternal serum biomarkers and placental micro-particles (MP) correlate with PA. The sensitivity and specificity of these proteins will be analyzed to further increase our understanding of the pathological mechanisms involved in PA. The knowledge gained from this study has the potential to develop a diagnostic test for PA with the ability to improve outcomes for mother and baby through earlier diagnosis and targeted therapy.

Eligibility criteria: Inclusion Criteria:

* Age 18 - to 45-years old, inclusive
* Suspected or confirmed PA or phenotypically matched controls
* All modes of delivery
* Gestational age greater than 28 weeks
* Singleton pregnancy

Exclusion Criteria:

* Intrauterine fetal demise,
* Severe fetal anomalies (infant not expected to survive)
* Inability to communicate in English

Primary outcomes:
measure: Determine the level of placental-derived MPs (Microparticles/mL)
timeFrame: Up to 75 minutes
measure: Identify biomarkers (picogram/mL) specifically, placental growth factor (PlGF), vascular endothelial growth factor (VEGF), soluble fms-like tyrosine kinase-1 (sFLT-1), and soluble endoglin (sEng)
timeFrame: Up to 75 minutes
Secondary outcomes:
measure: Examine the correlation between maternal serum total placental MPs and biomarkers to clinical symptomology and the severity of placental abruption after delivery.
timeFrame: Up to 75 minutes
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Nadir Shawrawi, MD
role: PRINCIPAL_INVESTIGATOR
References: