PregnancyTROPHYNCT01767649
Inflammatory Signature of Human Chorionic Cells
An observational study of Pregnancy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to identify molecules produced specifically by the cells from the chorionic membranes of the materno-fetal interface ("the water bag") sign for the activation of preterm labor. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Caesarean and Vaginal delivery
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2010to Nov 2014
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Normal pregnant women followed for their pregnancy in the maternity
Who may be able to join
- >18y old
- Singleton
- Normal pregnancy without complication
- >37 weeks of gestation
Who cannot join
- Minor
- Without Health Insurance
- Inflammatory Disorders (diabetes, twin, autoimmune disesses, etc)
- Infection HIV, hepatitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inflammatory Signature of Chorionic Cells as Markers of Premature Labor
The purpose of this study is to identify molecules produced specifically by the cells from the chorionic membranes of the materno-fetal interface ("the water bag") sign for the activation of preterm labor.
Read the detailed description
- Background
During human gestation, fetal membranes (the "water bag") encompass the amnion, facing the amniotic cavity, and the chorion, lining the maternal decidua and comprising trophoblast cells. Membranes usually remain intact until their spontaneous rupture, close to the first stage of labor at term. Often seen as a simple inert shell, with a role of "airbag" for the developing fetus, the membranes provide yet a large surface of interaction between maternal and fetal tissues and function as a transient endocrine organ with immune properties. Indeed human parturition is tightly correlated with hormonal changes at the maternal-fetal interface during pregnancy, that may control cell interactions and chorio-decidua remodeling, the amnion remaining usually intact until the final break. Precocious remodeling may lead to a premature onset of labor, associated or not with premature rupture of membrane whether the cause is infectious or not. A better understanding of this membrane remodeling may thus offer new avenues to define biomarkers of preterm labor.
Hereof, the fact that the mother-to-be accepts and keeps the fetus for months within her womb has long being seen as an enigma, since the fetus is a semi-allograft, half of his genome being of paternal, thus of foreign, origin. This apparent paradox was deciphered by the demonstration of the set-up of an immunotolerance at the site of implantation through the education of maternal immune cells (Natural Killer and T cells) by the fetal trophoblast. This immunotolerance is normally maintained throughout pregnancy, and some recurrent spontaneous miscarriages have been shown to be due to the loss of this immunotolerance, which activates the rejection of the semi-allograft.
In this regard, remodeled fetal membranes overlying the cervix may discharge signals that could be detectable in cervicovaginal fluids and serve as biomarkers of the imminence of delivery. Such information on delivery timing may be of great importance for an adequate prediction that would change drastically the management of threatening preterm delivery.
- Current proposal The objective of this study is to characterize the fetal and maternal cells in the chorio-decidua during the remodeling of the membranes using our well-established cell model (Hervé et al. 2008, J Immunol).
- Conditions
- Pregnancy
- Being tested
- Caesarean, Vaginal delivery
- Keywords
- Pregnancy, Remodelling, Extracellular matrix, Biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaesareanOther
Collection of tissues and blood
Vaginal deliveryOther
Collection of tissues and blood
| Study group | Role | What they receive |
|---|---|---|
| Caesarean | Normal pregnant women at term without complication during pregnancy and without inflammatory disorders Receives: Other: Caesarean | |
| Vaginal Delivery | Normal pregnant women at term without complication during pregnancy and without inflammatory disorders Receives: Other: Vaginal delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein overexpression
Setting of measurements of proteins in the supernatant of chorionic cells
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2013 (estimated)
- Study startNov 2010
- Primary completionMay 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Céline Méhats, PhD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767649
- Sponsor's protocol ID
- NI10056
- Acronym
- TROPHY
- Status last verified
- Feb 2026
- First submitted
- 11 Jan 2013
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Herve R, Schmitz T, Evain-Brion D, Cabrol D, Leroy MJ, Mehats C. The PDE4 inhibitor rolipram prevents NF-kappaB binding activity and proinflammatory cytokine release in human chorionic cells. J Immunol. 2008 Aug 1;181(3):2196-202. doi: 10.4049/jimmunol.181.3.2196.
PubMed 18641359Mehats C, Schmitz T, Marcellin L, Breuiller-Fouche M. [Biochemistry of fetal membranes rupture]. Gynecol Obstet Fertil. 2011 Jun;39(6):365-9. doi: 10.1016/j.gyobfe.2011.04.006. Epub 2011 May 24. French.
PubMed 21602079Marcellin L, Schmitz T, Messaoudene M, Chader D, Parizot C, Jacques S, Delaire J, Gogusev J, Schmitt A, Lesaffre C, Breuiller-Fouche M, Caignard A, Vaiman D, Goffinet F, Cabrol D, Gorochov G, Mehats C. Immune Modifications in Fetal Membranes Overlying the Cervix Precede Parturition in Humans. J Immunol. 2017 Feb 1;198(3):1345-1356. doi: 10.4049/jimmunol.1601482. Epub 2016 Dec 28.
PubMed 28031337
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Signature of Chorionic Cells as Markers of Premature Labor
- ClinicalTrials.gov ID
- NCT01767649
- Acronym / sponsor ID
- TROPHY / NI10056
- Conditions
- Pregnancy
- Keywords
- Pregnancy, Remodelling, Extracellular matrix, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Nov 2010
- Primary completion
- May 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 14 Jan 2013 (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 identify molecules produced specifically by the cells from the chorionic membranes of the materno-fetal interface ("the water bag") sign for the activation of preterm labor.
Detailed description
- Background
During human gestation, fetal membranes (the "water bag") encompass the amnion, facing the amniotic cavity, and the chorion, lining the maternal decidua and comprising trophoblast cells. Membranes usually remain intact until their spontaneous rupture, close to the first stage of labor at term. Often seen as a simple inert shell, with a role of "airbag" for the developing fetus, the membranes provide yet a large surface of interaction between maternal and fetal tissues and function as a transient endocrine organ with immune properties. Indeed human parturition is tightly correlated with hormonal changes at the maternal-fetal interface during pregnancy, that may control cell interactions and chorio-decidua remodeling, the amnion remaining usually intact until the final break. Precocious remodeling may lead to a premature onset of labor, associated or not with premature rupture of membrane whether the cause is infectious or not. A better understanding of this membrane remodeling may thus offer new avenues to define biomarkers of preterm labor.
Hereof, the fact that the mother-to-be accepts and keeps the fetus for months within her womb has long being seen as an enigma, since the fetus is a semi-allograft, half of his genome being of paternal, thus of foreign, origin. This apparent paradox was deciphered by the demonstration of the set-up of an immunotolerance at the site of implantation through the education of maternal immune cells (Natural Killer and T cells) by the fetal trophoblast. This immunotolerance is normally maintained throughout pregnancy, and some recurrent spontaneous miscarriages have been shown to be due to the loss of this immunotolerance, which activates the rejection of the semi-allograft.
In this regard, remodeled fetal membranes overlying the cervix may discharge signals that could be detectable in cervicovaginal fluids and serve as biomarkers of the imminence of delivery. Such information on delivery timing may be of great importance for an adequate prediction that would change drastically the management of threatening preterm delivery.
- Current proposal The objective of this study is to characterize the fetal and maternal cells in the chorio-decidua during the remodeling of the membranes using our well-established cell model (Hervé et al. 2008, J Immunol).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caesarean | – | Other: CaesareanNormal pregnant women at term without complication during pregnancy and without inflammatory disorders |
| Vaginal Delivery | – | Other: Vaginal deliveryNormal pregnant women at term without complication during pregnancy and without inflammatory disorders |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Normal pregnant women followed for their pregnancy in the maternity
Key inclusion criteria (4 listed)
- >18y old
- Singleton
- Normal pregnancy without complication
- >37 weeks of gestation
Key exclusion criteria (4 listed)
- Minor
- Without Health Insurance
- Inflammatory Disorders (diabetes, twin, autoimmune disesses, etc)
- Infection HIV, hepatitis
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 |
|---|---|---|
| CaesareanCollection of tissues and blood | Other | Caesarean |
| Vaginal deliveryCollection of tissues and blood | Other | Vaginal Delivery |
Primary outcome
Protein overexpression
Time frame: 1 year
Setting of measurements of proteins in the supernatant of chorionic cells
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 13 Feb 2026.
- Background: PubMed 18641359Herve R, Schmitz T, Evain-Brion D, Cabrol D, Leroy MJ, Mehats C. The PDE4 inhibitor rolipram prevents NF-kappaB binding activity and proinflammatory cytokine release in human chorionic cells. J Immunol. 2008 Aug 1;181(3):2196-202. doi: 10.4049/jimmunol.181.3.2196.
- Background: PubMed 21602079Mehats C, Schmitz T, Marcellin L, Breuiller-Fouche M. [Biochemistry of fetal membranes rupture]. Gynecol Obstet Fertil. 2011 Jun;39(6):365-9. doi: 10.1016/j.gyobfe.2011.04.006. Epub 2011 May 24. French.
- Results publication: PubMed 28031337Marcellin L, Schmitz T, Messaoudene M, Chader D, Parizot C, Jacques S, Delaire J, Gogusev J, Schmitt A, Lesaffre C, Breuiller-Fouche M, Caignard A, Vaiman D, Goffinet F, Cabrol D, Gorochov G, Mehats C. Immune Modifications in Fetal Membranes Overlying the Cervix Precede Parturition in Humans. J Immunol. 2017 Feb 1;198(3):1345-1356. doi: 10.4049/jimmunol.1601482. Epub 2016 Dec 28.
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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.
Céline Méhats, PhD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
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 Pregnancy, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 4 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 13 Feb 2026. 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 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?
Protein overexpression (time frame: 1 year). 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 NCT01767649, which also lists 3 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 13 Feb 2026.