NCT03782168

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 20, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

January 31, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

September 3, 2024

Status Verified

October 1, 2021

Enrollment Period

Same day

First QC Date

December 10, 2018

Last Update Submit

August 29, 2024

Conditions

Abruptio Placentae

Outcome Measures

Primary Outcomes (2)

  • 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 PA compared to 10 matched control subjects.

    Up to 75 minutes

  • 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)

    Determine quantitatively the level of biomarkers which may be altered in 10 subjects with PA compared to 10 matched control subjects.

    Up to 75 minutes

Secondary Outcomes (1)

  • Examine the correlation between maternal serum total placental MPs and biomarkers to clinical symptomology and the severity of placental abruption after delivery.

    Up to 75 minutes

Study Arms (2)

Placental Abruption

Mother-infant dyads with suspected or confirmed diagnosis of placental abruption

Other: There is no other intervention, only clinical treatment.

Phenotypically-matched controlled group

Healthy mother-infant dyads admitted for delivery

Other: There is no other intervention, only clinical treatment.

Interventions

There is no other intervention, only clinical treatment.OTHER

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.

Phenotypically-matched controlled groupPlacental Abruption

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Mother-infant dyads with suspected or confirmed diagnosis of placental abruption and healthy mother-infant dyads admitted for delivery.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood for serum biomarkers and placental micro-particles.

MeSH Terms

Conditions

Abruptio Placentae

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Study Officials

  • Nadir Shawrawi, MD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2018

First Posted

December 20, 2018

Study Start

January 31, 2019

Primary Completion

January 31, 2019

Study Completion

August 1, 2021

Last Updated

September 3, 2024

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)