Intrauterine InfectionINFIL-6NCT05793970
IL6 on Umbilical Cord (Evaluation of IL-6 Levels on Umbilical Cord)
An observational study of Intrauterine Infection and Fetus Disorder, run by Parma University Hospital at 2 sites in Italy.
Trial summary
Fetal inflammatory response syndrome (FIRS) is a major cause of non-hypoxic fetal intrapartum injury. One of the most common determinants of FIRS during labor is the exposure to an ongoing intra-amniotic infectious agent as in the event of a chorioamnionitis. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Intrauterine Infection, Fetus Disorder
- How many people
- 450 participants
- Where
- 2 sitesItaly
- Study dates
- 25 Mar 2022to 1 Jun 2023
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: singleton pregnancies at term submitted to a continuous CTG tracing during labor
Who may be able to join
- singleton pregnancies at term submitted to a continuous CTG tracing during labor
- Exclusion Criteria:elective Cesarean Delivery, maternal tachycardia or pyrexia >38°C, drugs assumption
- -
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
University Hospital of Parma
Parma, 43123
Tullio Ghi, Professor
Elvira di Pasquo, MD
- Recruiting
Fondazione Universitaria Policlinico Gemelli
Roma, 00186
Antonio Lanzone, Professor
Alessandra Familiari, MD
About this study
Official title: Evaluation of IL-6 Levels on Umbilical Cord
Fetal inflammatory response syndrome (FIRS) is a major cause of non-hypoxic fetal intrapartum injury. One of the most common determinants of FIRS during labor is the exposure to an ongoing intra-amniotic infectious agent as in the event of a chorioamnionitis. Interleuchine-6 (IL-6) is considered a reliable hallmark of FIRS. No specific fetal heart rate pattern for the diagnosis of FIRS have been described so far at intrapartum Cardiotocography (CTG). The aim the present study is to investigate the correlation between intrapartum CTG findings and IL-6 levels on the arterial cord.
Read the detailed description
The labor will be managed according to the local protocol and 5mL of blood will collected from the umbilical artery soon after birth to determine the IL-6 values. CardioTocography (CTG) traces will be retrospectively reviewed by two expert operators that will be blinded to the IL-6 results and will categorize them as "inflammatory" or "not inflammatory".
Inflammatory pattern will be defined in presence of 1) inappropriately high FHR for the given gestational age and/or 2) an increase >10% compared with the FHR baseline values at admission without preceding deceleration with/without reduced variability or absent cycling.
The association between CTG findings as the umbilical levels of IL6 will be analyzed.
- Conditions
- Intrauterine Infection, Fetus Disorder
- Medical subject headings
- Fetal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
IL6 Levels
correlation between intrapartum CTG findings and IL-6 levels on the arterial cord
Measured: IL6 will be measured on the umbilical blood sampled within 5 minutes after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start25 Mar 2022
- Primary completion23 Mar 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intrauterine InfectionStudies of the same condition, open and under way.
- 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
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parma University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tullio Ghi, Parma University Hospital
- Investigators
- Tullio Ghi, Professor, Principal investigator, University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793970
- Sponsor's protocol ID
- 561/2021/OSS/AOUPR
- Acronym
- INFIL-6
- Status last verified
- Mar 2023
- First submitted
- 19 Mar 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jung E, Romero R, Yeo L, Diaz-Primera R, Marin-Concha J, Para R, Lopez AM, Pacora P, Gomez-Lopez N, Yoon BH, Kim CJ, Berry SM, Hsu CD. The fetal inflammatory response syndrome: the origins of a concept, pathophysiology, diagnosis, and obstetrical implications. Semin Fetal Neonatal Med. 2020 Aug;25(4):101146. doi: 10.1016/j.siny.2020.101146. Epub 2020 Oct 23.
PubMed 33164775Gotsch F, Romero R, Kusanovic JP, Mazaki-Tovi S, Pineles BL, Erez O, Espinoza J, Hassan SS. The fetal inflammatory response syndrome. Clin Obstet Gynecol. 2007 Sep;50(3):652-83. doi: 10.1097/GRF.0b013e31811ebef6.
PubMed 17762416Romero R, Chaemsaithong P, Docheva N, Korzeniewski SJ, Tarca AL, Bhatti G, Xu Z, Kusanovic JP, Chaiyasit N, Dong Z, Yoon BH, Hassan SS, Chaiworapongsa T, Yeo L, Kim YM. Clinical chorioamnionitis at term V: umbilical cord plasma cytokine profile in the context of a systemic maternal inflammatory response. J Perinat Med. 2016 Jan;44(1):53-76. doi: 10.1515/jpm-2015-0121.
PubMed 26360486Ren J, Qiang Z, Li YY, Zhang JN. Biomarkers for a histological chorioamnionitis diagnosis in pregnant women with or without group B streptococcus infection: a case-control study. BMC Pregnancy Childbirth. 2021 Mar 25;21(1):250. doi: 10.1186/s12884-021-03731-7.
PubMed 33765949
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of IL-6 Levels on Umbilical Cord
- ClinicalTrials.gov ID
- NCT05793970
- Acronym / sponsor ID
- INFIL-6 / 561/2021/OSS/AOUPR
- Conditions
- Intrauterine Infection, Fetus Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Parma University HospitalUniversity, hospital or other
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 23 Mar 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 31 Mar 2023 (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.
Fetal inflammatory response syndrome (FIRS) is a major cause of non-hypoxic fetal intrapartum injury. One of the most common determinants of FIRS during labor is the exposure to an ongoing intra-amniotic infectious agent as in the event of a chorioamnionitis. Interleuchine-6 (IL-6) is considered a reliable hallmark of FIRS. No specific fetal heart rate pattern for the diagnosis of FIRS have been described so far at intrapartum Cardiotocography (CTG). The aim the present study is to investigate the correlation between intrapartum CTG findings and IL-6 levels on the arterial cord.
Detailed description
The labor will be managed according to the local protocol and 5mL of blood will collected from the umbilical artery soon after birth to determine the IL-6 values. CardioTocography (CTG) traces will be retrospectively reviewed by two expert operators that will be blinded to the IL-6 results and will categorize them as "inflammatory" or "not inflammatory".
Inflammatory pattern will be defined in presence of 1) inappropriately high FHR for the given gestational age and/or 2) an increase >10% compared with the FHR baseline values at admission without preceding deceleration with/without reduced variability or absent cycling.
The association between CTG findings as the umbilical levels of IL6 will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- singleton pregnancies at term submitted to a continuous CTG tracing during labor
Key inclusion criteria (3 listed)
- singleton pregnancies at term submitted to a continuous CTG tracing during labor
- Exclusion Criteria:elective Cesarean Delivery, maternal tachycardia or pyrexia >38°C, drugs assumption
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IL6 Levels
Time frame: IL6 will be measured on the umbilical blood sampled within 5 minutes after birth
correlation between intrapartum CTG findings and IL-6 levels on the arterial cord
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Background: PubMed 33164775Jung E, Romero R, Yeo L, Diaz-Primera R, Marin-Concha J, Para R, Lopez AM, Pacora P, Gomez-Lopez N, Yoon BH, Kim CJ, Berry SM, Hsu CD. The fetal inflammatory response syndrome: the origins of a concept, pathophysiology, diagnosis, and obstetrical implications. Semin Fetal Neonatal Med. 2020 Aug;25(4):101146. doi: 10.1016/j.siny.2020.101146. Epub 2020 Oct 23.
- Background: PubMed 17762416Gotsch F, Romero R, Kusanovic JP, Mazaki-Tovi S, Pineles BL, Erez O, Espinoza J, Hassan SS. The fetal inflammatory response syndrome. Clin Obstet Gynecol. 2007 Sep;50(3):652-83. doi: 10.1097/GRF.0b013e31811ebef6.
- Background: PubMed 26360486Romero R, Chaemsaithong P, Docheva N, Korzeniewski SJ, Tarca AL, Bhatti G, Xu Z, Kusanovic JP, Chaiyasit N, Dong Z, Yoon BH, Hassan SS, Chaiworapongsa T, Yeo L, Kim YM. Clinical chorioamnionitis at term V: umbilical cord plasma cytokine profile in the context of a systemic maternal inflammatory response. J Perinat Med. 2016 Jan;44(1):53-76. doi: 10.1515/jpm-2015-0121.
- Background: PubMed 33765949Ren J, Qiang Z, Li YY, Zhang JN. Biomarkers for a histological chorioamnionitis diagnosis in pregnant women with or without group B streptococcus infection: a case-control study. BMC Pregnancy Childbirth. 2021 Mar 25;21(1):250. doi: 10.1186/s12884-021-03731-7.
- Individual participant dataSharing planned: Undecided
Related trials for Intrauterine Infection
RecruitingObservational study
Primitive Immunodeficiency, Intrauterine Devices and Menstrual Hygiene Products
Primary Immune Deficiency Diseases
Active, not recruitingObservational study
Analysis on the Health of Newborns in Three Hospitals, 2008-2024
Neonatal Morbidity and Mortality, Intrauterine Growth Disorders (IUGR and Macrosomia)
Not yet recruiting
Effects of Copper Versus Levonorgestrel Intrauterine Devices on Mucosal Microbiota and Barrier Function Among Young African Women
Vaginal Microbial Diversity
RecruitingObservational study
A Prospective Longitudinal Observational Cohort Study of Pregnant Women Residing at High Altitude in Bolivia
Hypertensive Disorder of Pregnancy, Pulmonary Arterial Hypertension
Not yet recruitingObservational study
Prevalence of Carriage of Extended-Spectrum Beta-Lactamase (ESBL)-Producing Enterobacteria in Preterm Premature Rupture of Membranes : A French Multicenter Cohort Study
Premature Rupture of Membranes, Enterobacteriaceae
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.
Tullio Ghi, Professor principal investigator
University of Parma
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrauterine Infection and Fetus Disorder, run by Parma University Hospital at 2 sites in Italy.
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 3 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tullio Ghi, Professor (+390521702434, tullio.ghi@unipr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL6 Levels (time frame: IL6 will be measured on the umbilical blood sampled within 5 minutes after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05793970, which also lists 4 linked publications.
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 31 Mar 2023.