Plasma Concentration of Biological Markers in Placenta Accreta Spectrum

NCT04525534 | Terminated

• 1 other identifier: 261299
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Placenta Accreta; Placenta Diseases

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 PAS and 10 phenotypically-matched controls.

  Up to 6 hours

• 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 Outcomes (1)

• 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.

  Up to 6 hours

Study Arms (2)

Placenta accreta spectrum

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

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

Phenotypically-matched controlled group

Mother-infant dyads admitted for delivery without placenta accreta spectrum

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

Interventions

There is no other intervention, only clinical treatment. OTHER

There is no other intervention, only clinical treatment

Phenotypically-matched controlled group; Placenta accreta spectrum

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Mother-infant dyads with suspected or confirmed diagnosis of PAS and healthy mother-infant dyads admitted for cesarean delivery

You may qualify if:

• 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

You may not qualify if:

• Intrauterine fetal demise,
• Severe fetal anomalies (infant not expected to survive)
• Emergent cesarean delivery

Sponsors & Collaborators

• University of Arkansas: lead

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

Placenta Accreta; Placenta Diseases

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Nadir e Sharawi, MD

  UAMS

  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: August 20, 2020
• First Posted: August 25, 2020
• Study Start: August 30, 2020
• Primary Completion: July 10, 2023
• Study Completion: July 10, 2023
• Last Updated: September 3, 2024

Record last verified: 2023-11

Locations

US (1)