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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

France1 site
  • CHUNimes

    Nîmes

Other trials in France

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.

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 groups in NCT04205383
Study groupRoleWhat they receive
pregnancypregnant women with normal pregnancy
Receives: Other: biological analyses
pregnancy with complicationspregnant women with placental-mediated complications of pregnancy type complications
Receives: Other: biological analyses
healthy volunteerhealthy, 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.

  1. Circulating levels : Protein HMGB1 ng/ml

    Protein HMGB1 ng/ml

    Measured: until the patient gives birth, up to 7 months on average

  2. Circulating levels : Citrullinated Histone H3 U/ml

    Citrullined Histone H3 U/ml

    Measured: until the patient gives birth, up to 7 months on average

  3. Circulating levels : Histone H1 U/ml

    Histone H1 U/ml

    Measured: until the patient gives birth, up to 7 months on average

  4. Circulating levels : Acetylated Histones U/ml

    Acetylated Histones U/ml

    Measured: until the patient gives birth, up to 7 months on average

  5. 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.

  1. First posted19 Dec 2019
  2. Study start1 Mar 2019
  3. Primary completion5 Nov 2019
  4. Study completion5 Nov 2019

Resources

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)
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

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.

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