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NCT04705935
Amniochorionic Membrane Cells in the Maternal Blood as a Biomarker for Preterm Birth
trial in Preterm Birth in 83 participants. Completed in 28 June 2024.
28 June 2024
Quick facts
| Lead sponsor | University of Aarhus |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 83 |
| Start date | 15 August 2022 |
| Primary completion | 28 June 2024 |
| Estimated completion | 28 June 2024 |
| Sites | 1 location across Denmark |
Conditions studied
- Preterm Birth — all drugs for Preterm Birth →
- Preterm Premature Rupture of Membrane — all drugs for Preterm Premature Rupture of Membrane →
- Preterm Labor — all drugs for Preterm Labor →
Sponsor
University of Aarhus
Who can join
18 and older, female only, with Preterm Birth or Preterm Premature Rupture of Membrane. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04705935
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04705935 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Aarhus
- Last refreshed: 18 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04705935.
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