mtDNA as Novel Biomarker for Intra-amniotic Infection
mtDNA
Circulating Cell-free Mitochondrial as a Novel Biomarker for Intra-amniotic Infection in Obstetrics
1 other identifier
observational
50
1 country
1
Brief Summary
Finding a predictive biomarker for IAI could improve the clinical outcome for the mother and the neonate. The aim of this study is to quantify the copy number of circulating cell-free mitochondrial DNA in maternal serum and the placenta compared to controls.the investigators hypothesise that circulating cell-free mitochondrial DNA levels could help predict the likelihood of early inflammation in IAI. In addition, mitochondrial DNA could be a promotor triggering the pathogenesis of systemic inflammation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 5, 2017
CompletedFirst Submitted
Initial submission to the registry
October 1, 2017
CompletedFirst Posted
Study publicly available on registry
October 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedOctober 11, 2017
October 1, 2017
1.2 years
October 1, 2017
October 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
mtDNA in Plasma
through study completion, an average of 1 year
Study Arms (2)
Study Group
The intervention group will be women with premature preterm rupture of membranes (pProm), suffering from IAI
Control Group
Pregnant women without IAI
Interventions
Eligibility Criteria
Pregnant women
You may qualify if:
- Pregnant women 2 weeks before scheduled elective caesarian section at term (control group)
- Pregnant women in week 22+0 until week 28+0 who are admitted because of pPROM (intervention group)
- aged between 18 and 45 years
- Provide signed and dated informed consent
You may not qualify if:
- Women younger than 18 years
- No written consent
- Patients suffering from any autoimmune disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Vienna
Vienna, 1090, Austria
Biospecimen
Venous blood samples and placental blood samples
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Herbert Kiss, MD, PhD
Medical University of Vienna
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
October 1, 2017
First Posted
October 11, 2017
Study Start
April 5, 2017
Primary Completion
June 30, 2018
Study Completion
December 31, 2018
Last Updated
October 11, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share
Biomarker pilot trial