Plasma Concentration of Biological Markers in Placenta Accreta Spectrum

NCT ID: NCT04525534

Last Updated: 2024-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-30

Study Completion Date

2023-07-10

Brief Summary

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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

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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.

Conditions

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Placenta Accreta Placenta Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Placenta accreta spectrum

Mother-infant dyads with suspected or confirmed diagnosis of placenta accreta spectrum

There is no other intervention, only clinical treatment.

Intervention Type OTHER

There is no other intervention, only clinical treatment

Phenotypically-matched controlled group

Mother-infant dyads admitted for delivery without placenta accreta spectrum

There is no other intervention, only clinical treatment.

Intervention Type OTHER

There is no other intervention, only clinical treatment

Interventions

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There is no other intervention, only clinical treatment.

There is no other intervention, only clinical treatment

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nadir e Sharawi, MD

Role: PRINCIPAL_INVESTIGATOR

UAMS

Locations

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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261299

Identifier Type: -

Identifier Source: org_study_id

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