Mitochondrial DNANCT04045223
Mitochondrial DNA Triggering Epidural Related Maternal Fever
An observational study of Mitochondrial DNA and Epidural Related Maternal Fever (ERMF), run by Medical University of Vienna at 1 site in Austria.
Trial summary
Background: Giving birth is a critical moment for the mother and the fetus, potentially accompanied by stress, tissue damage, cell injury, placental hypoxia and sometimes multisystem vascular syndrome known as preeclampsia. Epidural analgesia with a local anesthetic is a common anesthetic approach during labor. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Mitochondrial DNA, Epidural Related Maternal Fever (ERMF)
- What is being tested?
- Blood samples
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jul 2019to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients must meet inclusion criteria and must give written consent. Informed consent will be obtained only for conscious patients preoperative. The cause of admission will be noted, baseline demographics and clinical history will be recorded. Patients included are giving birth at the Department of Obstetrics and Feto-Maternal Medicine at the Medical University of Vienna between July 2019 and July 2020. We are expecting to need to observe 15 patients per group in order to prove our hypothesis in this pilot study.
Who may be able to join
- women
- between 18 and 45 years
- Para 0 or Para 1
- Gestational week
- Elective procedure 37±0 to 42±0
Who cannot join
- younger than 18 years
- Emergency procedures
- No written consent
- Fever <2 weeks
- Intraoperative conversion from one anesthetic or surgical procedure to another one.
- preeclampsia
Show all 10Show fewer
- HELLP syndrome
- intrauterine growth reduction
- gestational diabetes mellitus
- autoimmune disease
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna
Vienna, 1090
About this study
Official title: Circulating Cell-free Mitochondrial DNA Triggering Epidural Related Maternal Fever (ERMF) in Obstetric Anesthesia: a Pilot Study
Background: Giving birth is a critical moment for the mother and the fetus, potentially accompanied by stress, tissue damage, cell injury, placental hypoxia and sometimes multisystem vascular syndrome known as preeclampsia. Epidural analgesia with a local anesthetic is a common anesthetic approach during labor. Local anesthetics inhibit the oxidative phosphorylation and impair the synthesis of ATP, resulting in mitochondrial dysfunction and increased reactive oxygen species. Especially when the high demand of ATP during pregnancy cannot be reached, apoptosis will occur in an anaerobic environment. During apoptosis 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. These DAMPs are evolutionary conserved and have structural similarity to their bacterial ancestor. 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 and hypoxia.
Objective: The aim of this study is to investigate to role of epidural analgesia during birth, quantifying the copy number of circulating cell-free mitochondrial DNA in maternal serum and the placenta compared to controls. The investigators hypothesize that epidural analgesia with a local anesthetic has an effect on cell-free mitochondrial DNA levels, promoting the pathogenesis of ERMF and early inflammation. In addition, circulating mitochondrial DNA could be a potent biomarker for cell damage, early placenta hypoxia/insufficiency or preeclampsia.
Methods: For this study the investigators planned 3 groups each consisting of 15 patients. The intervention group (group 1) will be women with vaginal delivery having epidural analgesia and developing fever before delivery. The control group (group 2) will be women with vaginal delivery having an epidural analgesia without developing fever before delivery. Women with vaginal delivery without an epidural analgesia will serve as additional control (group 3). Blood will be taken at arrival at the delivery ward and immediately after delivery from a peripheral venous line. In addition, venous blood from the umbilical vein will be drawn postpartum. Axillary temperature will be measured routinely using a thermometer in a routine clinical fashion. Circulating cell-free mitochondrial DNA and other immunological markers will be quantified in maternal and umbilical cord (fetal) serum by real time quantitative PCR and statistical analysis will be performed by non-parametric tests.
- Being tested
- Blood samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
Maternal blood will be taken at arrival at the delivery unit and after delivery. Furthermore, placental blood will be taken after delivery.
| Study group | Role | What they receive |
|---|---|---|
| Epidural analgesia and fever | Group 1 will be patients with vaginal delivery and having an epidural analgesia that develop fever during delivery. Receives: Other: Blood samples | |
| Epidural analgesia and no fever | Group 2 will be patients with vaginal delivery and having an epidural analgesia that do not develop fever during delivery. Receives: Other: Blood samples | |
| No epidural analgesia | Group 3 serves as additional control group and consists of patients having no epidural analgesia and no fever. Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
quantity of circulating cell-free mitochondrial DNA
The aim of this study is to elucidate the influence of epidural analgesia (epidural analgesia or no epidural analgesia) during labor with regard to the quantity of circulating cell-free mitochondrial DNA in women developing ERMF.
Measured: change from quantity of baseline mtDNA to quantity of mtDNA immediately after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start1 Jul 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitochondrial DNAStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ass.-Prof. PD Dr. Klaus Ulrich Klein, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045223
- Sponsor's protocol ID
- 2119/2017
- Status last verified
- Dec 2021
- First submitted
- 25 Jul 2019
- Last updated
- 3 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Cell-free Mitochondrial DNA Triggering Epidural Related Maternal Fever (ERMF) in Obstetric Anesthesia: a Pilot Study
- ClinicalTrials.gov ID
- NCT04045223
- Acronym / sponsor ID
- 2119/2017
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Giving birth is a critical moment for the mother and the fetus, potentially accompanied by stress, tissue damage, cell injury, placental hypoxia and sometimes multisystem vascular syndrome known as preeclampsia. Epidural analgesia with a local anesthetic is a common anesthetic approach during labor. Local anesthetics inhibit the oxidative phosphorylation and impair the synthesis of ATP, resulting in mitochondrial dysfunction and increased reactive oxygen species. Especially when the high demand of ATP during pregnancy cannot be reached, apoptosis will occur in an anaerobic environment. During apoptosis 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. These DAMPs are evolutionary conserved and have structural similarity to their bacterial ancestor. 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 and hypoxia.
Objective: The aim of this study is to investigate to role of epidural analgesia during birth, quantifying the copy number of circulating cell-free mitochondrial DNA in maternal serum and the placenta compared to controls. The investigators hypothesize that epidural analgesia with a local anesthetic has an effect on cell-free mitochondrial DNA levels, promoting the pathogenesis of ERMF and early inflammation. In addition, circulating mitochondrial DNA could be a potent biomarker for cell damage, early placenta hypoxia/insufficiency or preeclampsia.
Methods: For this study the investigators planned 3 groups each consisting of 15 patients. The intervention group (group 1) will be women with vaginal delivery having epidural analgesia and developing fever before delivery. The control group (group 2) will be women with vaginal delivery having an epidural analgesia without developing fever before delivery. Women with vaginal delivery without an epidural analgesia will serve as additional control (group 3). Blood will be taken at arrival at the delivery ward and immediately after delivery from a peripheral venous line. In addition, venous blood from the umbilical vein will be drawn postpartum. Axillary temperature will be measured routinely using a thermometer in a routine clinical fashion. Circulating cell-free mitochondrial DNA and other immunological markers will be quantified in maternal and umbilical cord (fetal) serum by real time quantitative PCR and statistical analysis will be performed by non-parametric tests.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Epidural analgesia and fever | – | Other: Blood samplesGroup 1 will be patients with vaginal delivery and having an epidural analgesia that develop fever during delivery. |
| Epidural analgesia and no fever | – | Other: Blood samplesGroup 2 will be patients with vaginal delivery and having an epidural analgesia that do not develop fever during delivery. |
| No epidural analgesia | – | Other: Blood samplesGroup 3 serves as additional control group and consists of patients having no epidural analgesia and no fever. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients must meet inclusion criteria and must give written consent. Informed consent will be obtained only for conscious patients preoperative. The cause of admission will be noted, baseline demographics and clinical history will be recorded. Patients included are giving birth at the Department of Obstetrics and Feto-Maternal Medicine at the Medical University of Vienna between July 2019 and July 2020. We are expecting to need to observe 15 patients per group in order to prove our hypothesis in this pilot study.
Key inclusion criteria (5 listed)
- women
- between 18 and 45 years
- Para 0 or Para 1
- Gestational week
- Elective procedure 37±0 to 42±0
Key exclusion criteria (10 listed)
- younger than 18 years
- Emergency procedures
- No written consent
- Fever <2 weeks
- Intraoperative conversion from one anesthetic or surgical procedure to another one.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplesMaternal blood will be taken at arrival at the delivery unit and after delivery. Furthermore, placental blood will be taken after delivery. | Other | Epidural analgesia and fever, Epidural analgesia and no fever, No epidural analgesia |
Primary outcome
quantity of circulating cell-free mitochondrial DNA
Time frame: change from quantity of baseline mtDNA to quantity of mtDNA immediately after delivery
The aim of this study is to elucidate the influence of epidural analgesia (epidural analgesia or no epidural analgesia) during labor with regard to the quantity of circulating cell-free mitochondrial DNA in women developing ERMF.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitochondrial DNA and Epidural Related Maternal Fever (ERMF), run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quantity of circulating cell-free mitochondrial DNA (time frame: change from quantity of baseline mtDNA to quantity of mtDNA immediately after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2022; AzTrials last refreshed its copy on 1 Nov 2026.