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mtDNA as Novel Biomarker for Intra-amniotic Infection

NCT ID: NCT03306719

Last Updated: 2017-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-05

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Background: Intra-amniotic infection (IAI) or chorioamnionitis is a common condition seen in obstetrics leading to labor abnormalities such as uterine atony, postpartum bleeding and preterm labor (Schrag et al., 2006). Further adverse effects such as perinatal death, asphyxia, sepsis, pneumonia, respiratory distress and especially neurodevelopmental delay and cerebral palsy are associated with IAI (Buhimschi et al., 2009; Holzman, Lin, Senagore, \& Chung, 2007). Diagnosing IAI can be challenging due to its very heterogeneous clinical signs, which are often very insensitive for this condition. Clinical findings such as fever, tachycardia and maternal leukocytosis leave room for multiple differential diagnoses. During apoptosis (due to hypoxia, cell damage or infection) the cell membrane integrity is disturbed, releasing the cytoplasm into the blood circulation. Circulating cell-free mitochondrial DNA acts as a damage associated molecular pattern (DAMP) by activating the innate immune system leading to inflammation (Matzinger, 1994). These DAMPs are evolutionary conserved and have structural similarity to their bacterial ancestor (Zhang et al., 2010). Therefore, cell-free mitochondria can act as a potent agent triggering the immune system in an autoimmune manner as well as a biomarker for cell damage due to infection.

Objective: 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. Investigators hypothesize 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.

Methods: For this study the investiagtors planned 2 groups each consisting of 30 patients. The control group are pregnant women without IAI. The intervention group will be women with premature preterm rupture of membranes (pProm), suffering from IAI (meeting the diagnostic criteria for IAI suggested by the National Institute of Child Health and Human Development Workshop). 12ml of venous blood will be drawn from a peripheral venous line in addition to routine blood tests, when the patient arrives at the ward (2 weeks before delivery). A further 12ml of venous blood will be taken from the peripheral venous line, during delivery (during delivery). In addition, 12ml of venous blood will be drawn from the placenta postpartum. In total, 36 ml of blood will be withdrawn in each patient. Circulating cell-free mitochondrial DNA will be quantified in maternal and placental serum by real time quantitative PCR and statistical analysis will be performed by non-parametric tests.

Design: Single center, prospective, observational pilot trial.

Conditions

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Preterm Premature Rupture of Membrane

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Group

The intervention group will be women with premature preterm rupture of membranes (pProm), suffering from IAI

Blood sampling

Intervention Type BIOLOGICAL

Serial blood sampling

Control Group

Pregnant women without IAI

Blood sampling

Intervention Type BIOLOGICAL

Serial blood sampling

Interventions

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Blood sampling

Serial blood sampling

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Women younger than 18 years
* No written consent
* Patients suffering from any autoimmune disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Herbert Kiss

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Herbert Kiss, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Herbert Kiss, MD, PhD

Role: CONTACT

Phone: +43140400

Email: [email protected]

Facility Contacts

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Herbert Kiss, MD, PhD

Role: primary

Other Identifiers

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1115/2017

Identifier Type: -

Identifier Source: org_study_id