PregnancyGROSS-HISTNCT04205383
GROSS-HIST : Quantification of the Main Circulating Histones During Normal Pregnancy and Pregnancies With Placenta-mediated Complications
An observational study of Pregnancy and Pregnancy Complications, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Pregnancy generates an increased thrombotic risk, and placental-mediated diseases are a risk factor for cardiovascular diseases, in particular: pre-eclampsia (PE), intrauterine growth retardation (IUGR), retroplacental hematomas (HRP), late intrauterine fetal deaths (LIFD) of placental origin and preterm deliveries of… 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
- Pregnancy, Pregnancy Complications, Healthy Volunteers
- What is being tested?
- biological analyses
- How many people
- 115 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2019to 5 Nov 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: pregnant patient with a complication of the placental vascular pathology type (pre-eclampsia, eclampsia, HELLP syndrome, retroplacental hematoma, fetal death in utero) or venous thromboembolic disease (deep vein thrombosis, pulmonary embolism). AND pregnant woman, without complications (normal pregnancy), absence of identified chronic pathology, absence of a history of neoplastic pathology, absence of a history of thromboembolic disease, absence of a history of chronic infectious pathology, absence of acute pathology (benign infectious type) intercurrent within the previous 2 weeks. AND - female, healthy volunteer, non-pregnant, no identified chronic pathology, no history of neoplastic pathology, no history of thromboembolic disease, no history of chronic infectious pathology, no history of acute (benign infectious type) intercurrent pathology within the previous 2 weeks.
Who may be able to join
- General inclusion criteria :
- The patient must have given her free and informed consent and signed the consent
- The patient must be a member or beneficiary of a health insurance plan
- Only women are included
- The patient is at least 18 years old
- pregnant patient with a complication of the placental vascular pathology type (pre-eclampsia, eclampsia, HELLP syndrome, retroplacental hematoma, fetal death in utero) or venous thromboembolic disease (deep vein thrombosis, pulmonary embolism).
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- OR pregnant woman, without complications (normal pregnancy), absence of identified chronic pathology, absence of a history of neoplastic pathology, absence of a history of thromboembolic disease, absence of a history of chronic infectious pathology, absence of acute pathology (benign infectious type) intercurrent within the previous 2 weeks.
- OR
- female, healthy volunteer, non-pregnant, no identified chronic pathology, no history of neoplastic pathology, no history of thromboembolic disease, no history of chronic infectious pathology, no history of acute (benign infectious type) intercurrent pathology within the previous 2 weeks.
Who cannot join
- General non-inclusion criteria :
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under the protection of justice, under guardianship or curatorship
- Patient refuses to sign consent
- It is impossible to give informed information about
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- The patient does not read French fluently
- Criteria for non-inclusion regarding interfering diseases or associated conditions:
- The patient is undergoing hormonal ovarian stimulation treatment as part of medically assisted reproduction
- The patient is pregnant OR
- The patient is breastfeeding OR
- The patient has been giving birth for less than 3 months .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantification of the Main Circulating Histones During Normal Pregnancy and Pregnancies With Placenta-mediated Complications
Pregnancy generates an increased thrombotic risk, and placental-mediated diseases are a risk factor for cardiovascular diseases, in particular: pre-eclampsia (PE), intrauterine growth retardation (IUGR), retroplacental hematomas (HRP), late intrauterine fetal deaths (LIFD) of placental origin and preterm deliveries of vascular origin. They are responsible for significant maternal-fetal morbidity/mortality. Data published in 2007 by the Haute Autorité de Santé (HAS) show that hypertension and pre-eclampsia are, in France, at the origin of 3 to 8% of the risk of perinatal mortality.
During pregnancy, a transitional organ of foetal origin, the placenta, is established, which is essential for the maintenance and harmonious development of the pregnancy. The chorionic villus, in contact with maternal blood in the intervillous chamber, is the structural and functional unit of the placenta. After the initial implantation phase, the trophoblastic cell constituting the main part of the placental villi differs in two ways: (A) into "citrus cytotrophoblasts" whose cells will fuse to generate the multinucleated outer layer giving the syncytiotrophoblast that ensures fetal-maternal exchanges and endocrine functions of the placenta; (B) into "invasive extra-city cytotrophoblasts" essential for the effective anchoring of the placenta in the decidualized uterine mucosa and for the remodelling of the terminal uterine spiral arteries, whose resistance to blood flow must collapse to allow effective oxygenation of the villi. Extra-city trophoblasts change from an epithelial phenotype to an endothelial phenotype. They may thus be exposed to pro-thrombotic factors such as endothelial cells. A lack of trophoblastic invasion and incomplete remodelling of the spiral uterine arteries are responsible for placental hypo-perfusion, hypoxia and the occurrence of placenta-mediated pathologies (pre-eclampsia, intrauterine growth retardation, retroplacental hematoma, fetal loss and fetal death in utero). The most common placental-mediated disease is pre-eclampsia (5% of births). It corresponds to a complication occurring from the second trimester of pregnancy and which is clinically characterized by high blood pressure, oedema and proteinuria. It is responsible for premature deliveries and is a major cause of intrauterine growth restriction.
Read more
To date, there is no specific and early biomarker for the occurrence of placental vascular pathologies. Recent developments raise, for example, the question of circulating angiogenesis inhibitory factors (sFlt1, sEng) in pre-eclampsia. With regard to treatment, early administration of low-dose aspirin before 16 weeks of pregnancy seems to reduce the risk of pre-eclampsia, hence the importance of having very early markers of the disease. Discovering such markers is therefore one of the major challenges in strengthening women's follow-up and avoiding subsequent complications. For fetal losses and retroplacental hematoma, the administration of low molecular weight heparin has been shown to be effective. However, these treatments are not specific to placental vascular pathologies. Thus, understanding and exploring the cellular and molecular mechanisms of vascular-placental interface dysfunctions remains necessary to enable targeted management of patients feeding the general principle of precision medicine.
Compare the concentrations of (i) circulating histones involved in inflammation, proliferation, migration or cell differentiation (H3-citrullinated histone, acetylated histones (Pan-histones), H1 histone) and (ii) free HMGB1 protein between the three patient groups ("GrossN", "GrossC", "VolS").
The histones H3-citrullinated, acetylated histones (Pan-histones), H1 histone as well as the free HMGB1 protein will be quantified. This choice corresponds to the histones involved in inflammation, proliferation, migration or cell differentiation and can be quantified to date.
- Conditions
- Pregnancy, Pregnancy Complications, Healthy Volunteers
- Being tested
- biological analyses
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological analysesOther
The histones H3-citrullinated, acetylated histones (Pan-histones), H1 histone as well as the free HMGB1 protein will be quantified. This choice corresponds to the histones involved in inflammation, proliferation, migration or cell differentiation and can be quantified to date.
| Study group | Role | What they receive |
|---|---|---|
| pregnancy | pregnant women with normal pregnancy Receives: Other: biological analyses | |
| pregnancy with complications | pregnant women with placental-mediated complications of pregnancy type complications Receives: Other: biological analyses | |
| healthy volunteer | healthy, non-pregnant women volunteers Receives: Other: biological analyses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating levels : Protein HMGB1 ng/ml
Protein HMGB1 ng/ml
Measured: until the patient gives birth, up to 7 months on average
Circulating levels : Citrullinated Histone H3 U/ml
Citrullined Histone H3 U/ml
Measured: until the patient gives birth, up to 7 months on average
Circulating levels : Histone H1 U/ml
Histone H1 U/ml
Measured: until the patient gives birth, up to 7 months on average
Circulating levels : Acetylated Histones U/ml
Acetylated Histones U/ml
Measured: until the patient gives birth, up to 7 months on average
Circulating levels : Histone H3 U/ml
Histone H3 U/ml
Measured: until the patient gives birth, up to 7 months on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start1 Mar 2019
- Primary completion5 Nov 2019
- Study completion5 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Retrospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205383
- Sponsor's protocol ID
- Nimao/2018-03/SB-01
- Acronym
- GROSS-HIST
- Status last verified
- Jan 2022
- First submitted
- 16 Dec 2019
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bouvier S, Fortier M, Vincent L, Demattei C, Mousty E, Herzog M, Rommelaere G, Nouvellon E, Mercier E, Letouzey V, Gris JC. NETosis Markers in Pregnancy: Effects Differ According to Histone Subtypes. Thromb Haemost. 2021 Jul;121(7):877-890. doi: 10.1055/s-0040-1722225. Epub 2021 Jan 10.
PubMed 33423243
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of the Main Circulating Histones During Normal Pregnancy and Pregnancies With Placenta-mediated Complications
- ClinicalTrials.gov ID
- NCT04205383
- Acronym / sponsor ID
- GROSS-HIST / Nimao/2018-03/SB-01
- Conditions
- Pregnancy, Pregnancy Complications, Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 5 Nov 2019 (actual)
- Study completion
- 5 Nov 2019 (actual)
- First posted
- 19 Dec 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.
Pregnancy generates an increased thrombotic risk, and placental-mediated diseases are a risk factor for cardiovascular diseases, in particular: pre-eclampsia (PE), intrauterine growth retardation (IUGR), retroplacental hematomas (HRP), late intrauterine fetal deaths (LIFD) of placental origin and preterm deliveries of vascular origin. They are responsible for significant maternal-fetal morbidity/mortality. Data published in 2007 by the Haute Autorité de Santé (HAS) show that hypertension and pre-eclampsia are, in France, at the origin of 3 to 8% of the risk of perinatal mortality.
During pregnancy, a transitional organ of foetal origin, the placenta, is established, which is essential for the maintenance and harmonious development of the pregnancy. The chorionic villus, in contact with maternal blood in the intervillous chamber, is the structural and functional unit of the placenta. After the initial implantation phase, the trophoblastic cell constituting the main part of the placental villi differs in two ways: (A) into "citrus cytotrophoblasts" whose cells will fuse to generate the multinucleated outer layer giving the syncytiotrophoblast that ensures fetal-maternal exchanges and endocrine functions of the placenta; (B) into "invasive extra-city cytotrophoblasts" essential for the effective anchoring of the placenta in the decidualized uterine mucosa and for the remodelling of the terminal uterine spiral arteries, whose resistance to blood flow must collapse to allow effective oxygenation of the villi. Extra-city trophoblasts change from an epithelial phenotype to an endothelial phenotype. They may thus be exposed to pro-thrombotic factors such as endothelial cells. A lack of trophoblastic invasion and incomplete remodelling of the spiral uterine arteries are responsible for placental hypo-perfusion, hypoxia and the occurrence of placenta-mediated pathologies (pre-eclampsia, intrauterine growth retardation, retroplacental hematoma, fetal loss and fetal death in utero). The most common placental-mediated disease is pre-eclampsia (5% of births). It corresponds to a complication occurring from the second trimester of pregnancy and which is clinically characterized by high blood pressure, oedema and proteinuria. It is responsible for premature deliveries and is a major cause of intrauterine growth restriction.
To date, there is no specific and early biomarker for the occurrence of placental vascular pathologies. Recent developments raise, for example, the question of circulating angiogenesis inhibitory factors (sFlt1, sEng) in pre-eclampsia. With regard to treatment, early administration of low-dose aspirin before 16 weeks of pregnancy seems to reduce the risk of pre-eclampsia, hence the importance of having very early markers of the disease. Discovering such markers is therefore one of the major challenges in strengthening women's follow-up and avoiding subsequent complications. For fetal losses and retroplacental hematoma, the administration of low molecular weight heparin has been shown to be effective. However, these treatments are not specific to placental vascular pathologies. Thus, understanding and exploring the cellular and molecular mechanisms of vascular-placental interface dysfunctions remains necessary to enable targeted management of patients feeding the general principle of precision medicine.
Compare the concentrations of (i) circulating histones involved in inflammation, proliferation, migration or cell differentiation (H3-citrullinated histone, acetylated histones (Pan-histones), H1 histone) and (ii) free HMGB1 protein between the three patient groups ("GrossN", "GrossC", "VolS").
The histones H3-citrullinated, acetylated histones (Pan-histones), H1 histone as well as the free HMGB1 protein will be quantified. This choice corresponds to the histones involved in inflammation, proliferation, migration or cell differentiation and can be quantified to date.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pregnancy | – | Other: biological analysespregnant women with normal pregnancy |
| pregnancy with complications | – | Other: biological analysespregnant women with placental-mediated complications of pregnancy type complications |
| healthy volunteer | – | Other: biological analyseshealthy, non-pregnant women volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- pregnant patient with a complication of the placental vascular pathology type (pre-eclampsia, eclampsia, HELLP syndrome, retroplacental hematoma, fetal death in utero) or venous thromboembolic disease (deep vein thrombosis, pulmonary embolism). AND pregnant woman, without complications (normal pregnancy), absence of identified chronic pathology, absence of a history of neoplastic pathology, absence of a history of thromboembolic disease, absence of a history of chronic infectious pathology, absence of acute pathology (benign infectious type) intercurrent within the previous 2 weeks. AND - female, healthy volunteer, non-pregnant, no identified chronic pathology, no history of neoplastic pathology, no history of thromboembolic disease, no history of chronic infectious pathology, no history of acute (benign infectious type) intercurrent pathology within the previous 2 weeks.
Key inclusion criteria (9 listed)
- General inclusion criteria :
- The patient must have given her free and informed consent and signed the consent
- The patient must be a member or beneficiary of a health insurance plan
- Only women are included
- The patient is at least 18 years old
Key exclusion criteria (12 listed)
- General non-inclusion criteria :
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under the protection of justice, under guardianship or curatorship
- Patient refuses to sign consent
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 |
|---|---|---|
| biological analysesThe histones H3-citrullinated, acetylated histones (Pan-histones), H1 histone as well as the free HMGB1 protein will be quantified. This choice corresponds to the histones involved in inflammation, proliferation, migration or cell differentiation and can be quantified to date. | Other | healthy volunteer, pregnancy, pregnancy with complications |
Primary outcome
Circulating levels : Protein HMGB1 ng/ml
Time frame: until the patient gives birth, up to 7 months on average
Protein HMGB1 ng/ml
Circulating levels : Citrullinated Histone H3 U/ml
Time frame: until the patient gives birth, up to 7 months on average
Citrullined Histone H3 U/ml
Circulating levels : Histone H1 U/ml
Time frame: until the patient gives birth, up to 7 months on average
Histone H1 U/ml
Circulating levels : Acetylated Histones U/ml
Time frame: until the patient gives birth, up to 7 months on average
Acetylated Histones U/ml
Circulating levels : Histone H3 U/ml
Time frame: until the patient gives birth, up to 7 months on average
Histone H3 U/ml
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 Dec 2025.
- Results publication: PubMed 33423243Bouvier S, Fortier M, Vincent L, Demattei C, Mousty E, Herzog M, Rommelaere G, Nouvellon E, Mercier E, Letouzey V, Gris JC. NETosis Markers in Pregnancy: Effects Differ According to Histone Subtypes. Thromb Haemost. 2021 Jul;121(7):877-890. doi: 10.1055/s-0040-1722225. Epub 2021 Jan 10.
- Individual participant dataSharing planned: No
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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 Pregnancy and Pregnancy Complications, run by Centre Hospitalier Universitaire de Nīmes 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 9 inclusion and 12 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 Dec 2025. 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?
Circulating levels : Protein HMGB1 ng/ml (time frame: until the patient gives birth, up to 7 months on average). The study lists 5 primary outcomes in all. 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 NCT04205383, which also lists 1 linked publication.
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 Dec 2025.