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

NCT04705935 | Completed

• 1 other identifier: AU011020
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth; Preterm Premature Rupture of Membrane; Preterm Labor

Keywords

Amniochorionic Membrane Cells; Fetal Membrane Cells

Outcome Measures

Primary Outcomes (1)

• ACM cells in maternal blood

  Number

  At inclusion

Secondary Outcomes (4)

• Gestational age at delivery

  At delivery

• Birth weight of child

  At delivery

• APGAR score

  At delivery

• Sex of child

  At delivery

Other Outcomes (2)

• Maternal age

  At inclusion

• Maternal BMI

  At inclusion

Study Arms (8)

Term pregnant women without labor contractions or rupture of membranes

Term pregnant women \> 37 weeks gestation with a normal pregnancy. One blood sample before a scheduled caesarean section.

Term pregnant women with labor contractions

Term pregnant women \> 37 weeks gestation with a normal pregnancy. One blood sample when labor contractions, but before spontaneous rupture of membranes.

Term pregnant women with spontaneous rupture of membranes

Term pregnant women \> 37 weeks gestation with a normal pregnancy. One blood sample after spontaneous rupture of membranes, but without labor contractions.

Preterm labor contractions (PLC)

One blood sample when labor contractions before 34 weeks gestation without rupture of membranes.

Preterm Prelabor Rupture of the Fetal Membranes (PPROM)

One blood sample when rupture of the fetal membranes before 34 weeks gestation without labor contractions.

Control group

Women with normal pregnancies. One blood sample in gestation week 25+0 to 37 matched as controls for PLC and PPROM cases.

Longitudinal cohort during pregnancy

Women with normal pregnancies, where blood samples will be collected at week 12, 20, 28, 34 and 36, as well as at labor.

Longitudinal cohort post partum

Women with normal pregnancies, where blood samples will be collected at labor, as well as 2 days, and 4, 8 and 12 weeks after birth.

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women who complies to the above mentioned inclusion and exclusion criteria.

You may qualify if:

• 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 37.
• Normal pregnancy at gestational age 12 included at the nuchal translucency scan.
• Normal pregnancy at birth.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Arcedi Biotech: collaborator
• Aarhus University Hospital: collaborator
• The University of Texas Medical Branch, Galveston: collaborator
• Medical University of Graz: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Premature Birth; Preterm Premature Rupture of the Membranes; Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

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

Study Officials

• Ramkumar Menon, PhD

  The University of Texas Medical Branch, Galveston

  STUDY CHAIR

• Torben Steiniche, DMSc

  Aarhus University Hospital

  STUDY CHAIR

• Palle Schelde, MSc

  Arcedi Biotech

  PRINCIPAL INVESTIGATOR

• Ripudaman Singh, PhD

  Arcedi Biotech

  STUDY CHAIR

• Berthold Huppertz, PhD

  Medical University of Graz

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: January 12, 2021
• Study Start: August 15, 2022
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Locations

DK (1)