Pathology of PregnancyICARNCT01610258
Maternal Plasmatic Regulatory T Cells and Th17 as Possible Diagnosis Markers of Acute Chorioamnionitis
A study testing Blood and placenta samples in people with Pathology of Pregnancy, run by Centre Hospitalier Universitaire Dijon at 2 sites in France.
Trial summary
The purpose of this study is to evaluate if regulator T cells (Treg) and Th17 level modifications in maternal blood and placenta could be correlated to a chorioamnionitis, in women hospitalized for PPROM. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pathology of Pregnancy
- What is being tested?
- Blood and placenta samples
- How many people
- 95 participants
- Where
- 2 sitesFrance
- Study dates
- 26 Mar 2013to 8 Dec 2016
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent signed
- Patient affiliated with a social security scheme
- term pregnancy betwwen 24 and 34 weeks
- PPROM diagnosis
- singleton pregnancy
Who cannot join
- delivery occured in 1 hour after admission
- hemorragic praevia placenta or retro-placental hematoma
- confirmed autoimmune or inflammatory disease
- confirmed infectious disease by VIH, VHC, and VHB
Trial locations and contacts
2 sites in 1 country.
France2 sites
Maternité du CHU de Dijon
Dijon, Bourgogne-Franche-Comté, 21000
Hôpital Hautepierre
Strasbourg, 67200
About this study
Official title: Contribution of the Study of Maternal Plasmatic Regulator T Cells and Th17 for the Diagnosis of Acute Chorioanmionitis Among Women Hospitalized for Premature Rupture of Fetal Membranes (PPROM) Between 24 and 34 Gestation Weeks
The purpose of this study is to evaluate if regulator T cells (Treg) and Th17 level modifications in maternal blood and placenta could be correlated to a chorioamnionitis, in women hospitalized for PPROM.
Read the detailed description
Acute chorioamnionitis is the principal antecedent of premature birth and an important contributor to specific neonatal and other complications that may extend throughout subsequent life. The PPROM is a high risk condition for developing chorioamnionitis. Available biological markers have a low prognostic value. Indeed, currently the diagnosis of intra-uterine infection relies only on placental cultures and anatomo-pathological exam after the delivery.
Moreover, pregnancy is an immunologic particular condition. Indeed an immune tolerance is required with respect to the fetus and is mediated by Treg lymphocytes, which suppressed Th17 activity.
Recent studies have shown among women with frequent miscarriages, a balance between Treg and Th17, with a decrease in Treg number and an increase in Th17 number in decidua and blood.
In case of infection, the immune pro-inflammatory response (Th17) is restored in peripheric tissues and in blood in order to limit the extention of intra-uterine infection. This restoration of this pro-inflammatory response could be due to a modification of Treg number ou tolerogenic activity.
In this context, our hypothesis is that chorioamnionitis will lead to a decrease of treg proportion and an increase of Th17 proportion in lymphocyte populations of maternal blood and placenta, with a back to values near than which is observed in beginning of pregnancy or in no pregnant women.
- Conditions
- Pathology of Pregnancy
- Being tested
- Blood and placenta samples
- Keywords
- pregnancy, chorioamnionitis, PPROM, Treg
- Medical subject headings
- Chorioamnionitis, Preterm Premature Rupture of the Membranes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and placenta samplesOther
The placenta sample is realised, specially for the study, in surgical unit after the delivery.
The blood samples are taken, specially for the study, the day of admission and at time of delivery or seven days after the admission.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the percentage of Treg in maternal blood at the time of admission
Measured: the day of delivery or 7 days after the admission if no delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2012 (estimated)
- Study start26 Mar 2013
- Primary completion8 Dec 2016
- Study completion8 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathology of PregnancyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01610258
- Sponsor's protocol ID
- BARDOU-PHRC-2011
- Acronym
- ICAR
- Status last verified
- Feb 2024
- First submitted
- 31 May 2012
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of the Study of Maternal Plasmatic Regulator T Cells and Th17 for the Diagnosis of Acute Chorioanmionitis Among Women Hospitalized for Premature Rupture of Fetal Membranes (PPROM) Between 24 and 34 Gestation Weeks
- ClinicalTrials.gov ID
- NCT01610258
- Acronym / sponsor ID
- ICAR / BARDOU-PHRC-2011
- Conditions
- Pathology of Pregnancy
- Keywords
- pregnancy, chorioamnionitis, PPROM, Treg
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 26 Mar 2013 (actual)
- Primary completion
- 8 Dec 2016 (actual)
- Study completion
- 8 Dec 2016 (actual)
- First posted
- 1 Jun 2012 (estimated)
- 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.
The purpose of this study is to evaluate if regulator T cells (Treg) and Th17 level modifications in maternal blood and placenta could be correlated to a chorioamnionitis, in women hospitalized for PPROM.
Detailed description
Acute chorioamnionitis is the principal antecedent of premature birth and an important contributor to specific neonatal and other complications that may extend throughout subsequent life. The PPROM is a high risk condition for developing chorioamnionitis. Available biological markers have a low prognostic value. Indeed, currently the diagnosis of intra-uterine infection relies only on placental cultures and anatomo-pathological exam after the delivery.
Moreover, pregnancy is an immunologic particular condition. Indeed an immune tolerance is required with respect to the fetus and is mediated by Treg lymphocytes, which suppressed Th17 activity.
Recent studies have shown among women with frequent miscarriages, a balance between Treg and Th17, with a decrease in Treg number and an increase in Th17 number in decidua and blood.
In case of infection, the immune pro-inflammatory response (Th17) is restored in peripheric tissues and in blood in order to limit the extention of intra-uterine infection. This restoration of this pro-inflammatory response could be due to a modification of Treg number ou tolerogenic activity.
In this context, our hypothesis is that chorioamnionitis will lead to a decrease of treg proportion and an increase of Th17 proportion in lymphocyte populations of maternal blood and placenta, with a back to values near than which is observed in beginning of pregnancy or in no pregnant women.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent signed
- Patient affiliated with a social security scheme
- term pregnancy betwwen 24 and 34 weeks
- PPROM diagnosis
- singleton pregnancy
Key exclusion criteria (4 listed)
- delivery occured in 1 hour after admission
- hemorragic praevia placenta or retro-placental hematoma
- confirmed autoimmune or inflammatory disease
- confirmed infectious disease by VIH, VHC, and VHB
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 and placenta samplesThe placenta sample is realised, specially for the study, in surgical unit after the delivery. The blood samples are taken, specially for the study, the day of admission and at time of delivery or seven days after the admission. | Other | – |
Primary outcome
Evaluate the percentage of Treg in maternal blood at the time of admission
Time frame: the day of delivery or 7 days after the admission if no delivery
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 22 Feb 2024.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood and placenta samples in people with Pathology of Pregnancy, run by Centre Hospitalier Universitaire Dijon at 2 sites in France.
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 4 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 22 Feb 2024. 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 France. 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?
Evaluate the percentage of Treg in maternal blood at the time of admission (time frame: the day of delivery or 7 days after the admission if no 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 22 Feb 2024.