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Amniochorionic Membrane Cells in the Maternal Blood as a Biomarker for Preterm Birth

NCT04705935 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 83

Last updated 2024-12-18

No results posted yet for this study

Summary

Globally, preterm birth (15 mill. per year) is the leading cause of under-5 child mortality (1 mill. per year) and morbidity. Important pathways include preterm labor contractions, Preterm Prelabor Rupture of the Fetal Membranes (PPROM), and iatrogenic delivery. At labor, the fetal amniochorionic membrane undergoes a cellular senescence and shed fetal amniochorionic membrane cells (ACM cells) to the maternal circulation. In collaboration with the private firm ARCEDI Biotech and The University of Texas Medical Branch at Galveston, Aarhus University has identified specific antibodies, which can be used to isolate ACM cells from maternal blood. Thus, the aim of this study is 1) to characterize ACM cells by histological and immunological techniques, and 2) in a cohort assess their performance as biomarkers of amniochorionic membrane dysfunction, including early detection of threatening preterm birth. In perspective, the findings are expected to improve the diagnostics and treatment of preterm birth.

Conditions

  • Preterm Birth
  • Preterm Premature Rupture of Membrane
  • Preterm Labor

Sponsors & Collaborators

  • Arcedi Biotech

    collaborator INDUSTRY

  • Aarhus University Hospital

    collaborator OTHER

  • The University of Texas Medical Branch, Galveston

    collaborator OTHER

  • Medical University of Graz

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Ramkumar Menon, PhD · University of Texas Medical Branch at Galveston

  • Torben Steiniche, DMSc · Aarhus University Hospital

  • Palle Schelde, MSc · Arcedi Biotech

  • Ripudaman Singh, PhD · Arcedi Biotech

  • Berthold Huppertz, PhD · Medical University of Graz

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-15
Primary Completion
2024-06-28
Completion
2024-06-28

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04705935 on ClinicalTrials.gov