Amniochorionic Membrane Cells in the Maternal Blood as a Biomarker for Preterm Birth
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 83
- Locations
- 1
- Primary Endpoint
- ACM cells in maternal blood
Study Overview
Brief 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.
Detailed Description
Aim:
The aim of the study is 1) to characterize circulating fetal amniochorionic membrane cells (ACM cells) in pregnant women and 2) to investigate if they can function as biomarkers of amniochorionic membrane dysfunction, including risk of preterm birth.
Background:
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 (PLC), Preterm Prelabor Rupture of the Fetal Membranes (PPROM), and iatrogenic delivery due to preeclampsia and fetal growth restriction.
At labor, the fetal amniochorionic membrane undergoes a cellular senescence and shed fetal amniochorionic membrane cells (ACM cells) to the maternal circulation. Similar features are expected to be seen in cases with PPROM. In collaboration with ARCEDI Biotech Aps and the University of Texas Medical Branch at Galveston, Aarhus University has identified specific fetal membrane cell markers, i.e. specific proteins highly expressed by the ACM cells. Commercially available antibodies specific for these identified proteins can be used to isolate ACM cells from the maternal blood. The preliminary studies indicate that circulating ACM cells are present in the second half of pregnancy but not in the first half of pregnancy.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Normal pregnancy at term (> 37 weeks) the day before a planned caesarean section.
- •Normal pregnancy at term (> 37 weeks) with planned vaginal delivery.
- •Women with preterm labor contractions < 34 weeks admitted at the hospital.
- •Women with PPROM < 34 weeks admitted at the hospital.
- •Normal pregnancy at gestational age 25+0 to
- •Normal pregnancy at gestational age 12 included at the nuchal translucency scan.
- •Normal pregnancy at birth.
Exclusion Criteria
- •Maternal age < 18
- •Women who does not understand the oral or written information
- •Women who does not speak Danish
- •Women who does not want to participate
- •Women with complications in pregnancy
Outcomes
Primary Outcomes
ACM cells in maternal blood
Time Frame: At inclusion
Number
Secondary Outcomes
- Gestational age at delivery(At delivery)
- Birth weight of child(At delivery)
- APGAR score(At delivery)
- Sex of child(At delivery)
Investigators
Niels Uldbjerg
Professor
University of Aarhus