ELGAN (22-28SA)ELGAN AMINESNCT06737965
Cardiovascular Immaturity in Extremely Low Gestational Age Newborns: a Fundamental Prospective Study
An observational study of ELGAN (22-28SA) and Extremely Low Gestational Age Newborns, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Birth is a major turning point in the life of the newborn, as it moves from intrauterine life to extrauterine life. This sudden transition forces the newborn to adapt quickly. Oxygenation, which was only provided by the placenta during uterine life, will have to be provided by the lungs, which will open when the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ELGAN (22-28SA), Extremely Low Gestational Age Newborns, Cardiovascular Immaturity
- What is being tested?
- Medical abortion, Foetopathology exam and Outcomes mesurement
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2025to 31 Dec 2025
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All pregnant woman who will receive a medical abortion at Montpellier Hospital and who present eligibility criteria for her and her foetus will be invited to participate to the study
Who may be able to join
- For the pregnant women:
- Over 18 years old.
- Speaks and understands French.
- Medical abortion requested by the participant, scheduled and validated by the CPDPN of the Montpellier University Hospital.
- Participant's agreement to use for research purposes the biological tissues from the systematic foetopathological examination.
- For fetuses:
- Interest group: Fœtus ≥ 22 WA and <28 WA
- Control group: Fœtus ≥ 34 WA
Who cannot join
- For the pregnant women :
- Injection of betamethasone or maternal use of dexamethasone in the month before foeticide
- Known family genetic mutation that may be linked with cardiomyopathy
- Failure to obtain consent (adults, unemancipated minors, persons unable to give consent)
- Not affiliated to a social security
- Persons under legal protection
Show all 12Show fewer
- Person taking part in another research study with an exclusion period still in progress.
- For fetuses:
- Fetus from unplanned in-utero death
- Significant cardiac malformation suspected antenatally (excluding atrial septal defect ostium secundum and isolated muscular ventricular septal defect).
- Suspected abnormality of myocardial tissue
- Biological tissue sampling more than 48 hours after fœticide
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Montpellier
Montpellier, 34000
Arthur GAVOTTO, Doctor, +33 04 67 33 66 09, a-gavotto@chu-montpellier.fr
About this study
Birth is a major turning point in the life of the newborn, as it moves from intrauterine life to extrauterine life. This sudden transition forces the newborn to adapt quickly. Oxygenation, which was only provided by the placenta during uterine life, will have to be provided by the lungs, which will open when the newborn cries for the first time. This phenomenon will change the way blood reaches the lungs and will require the newborn's heart to work harder. In addition, the cardiac workload will also increase due to the clamping of the umbilical cord, which will force the heart to pump through more resistant blood vessels.
This transition, generally well tolerated in newborns at term, can be much more complicated in premature newborns, particularly in extremely low gestational age newborns (e.g. ELGAN, born before 28 weeks of amenorrhoea). There are several causes of this difficult adaptation on the cardiovascular system: poor heart function, difficulty in revascularizing lungs due to the physiological characteristics of premature newborns (high pulmonary vascular resistance, persistence of the ductus arteriosus), and a tone of the blood vessel muscles that is probably immature. In addition, respiratory failure is often associated with pulmonary immaturity.
Read more
The consequences of a difficult adaptation to extrauterine life, combined with cardiovascular failure, will be poor organ perfusion, whose brain. Moreover, ELGANs have immature regulation of their brain vascularisation. Variations in the vascularisation of the brain (in the event of cardiovascular failure) may be responsible for irreversible lesions with intraventricular hemorrhage. Ultimately, these bleedings carry a high risk of mortality or severe disability in premature infants.
Several hypotheses have been put forward as to the causes of this poor adaptation to extrauterine life, but there are few recommendations on adapted medical management. Cardiac ultrasound and the use of drugs to support the heart and blood vessels have been suggested. However, a large number of ELGANs will develop complications that investigators cannot predict or intervene in time. In addition, studies on the drugs used have not been carried out on ELGANs, which limits the conclusions investigators can draw.
These factors encourage us to improve our fundamental knowledge of the cardiovascular system in the ELGANs. The aim is to identify the most effective clinical tools and treatments for assessing and treating neonatal cardiovascular failure at an early stage, before complications appear. Investigators aim to compare the architecture and composition of the heart, blood vessels, and blood of fetuses under 28 weeks of amenorrhea gestation with those of fetuses over or equal to 34 weeks of amenorrhea gestation.
For this research, investigators need tissues (heart muscle, blood, and vessels) from fetuses of different ages. These tissues are usually already taken during the foetopathology examination to try to provide a medical explanation of the medical abortion. There will be no change to the foetopathology examination carried out on the foetus, with the exception that some of the tissue taken will have additional analyses carried out in our INSERM laboratory attached to the Montpellier University Hospital.
Population resulting from medical abortion is motivated by the ethical impossibility of taking such invasive samples from live newborns. The non-use of animals is justified by the difficulty of extrapolating results to humans. The indication for abortion and its performance will be carried out by current practice. Participants will be offered and explained the study during the pre abortion visit.
This research does not alter the patient's care. No additional examination or consultation is required. No personal benefit is expected from the study, but it will enable us to gain a better understanding of ELGAN's hemodynamics and to consider future clinical studies.
- Being tested
- Medical abortion, Foetopathology exam, Outcomes mesurement
- Keywords
- Cardiovascular immaturity in extremely premature infants, vasoactive agent, vascular reactivity, cardiac adrenergic receptor, cardiac architecture, vascular response, Extremely low gestational age newborns, cardio-circulatory insufficiency, myocardial contraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical abortionOther
Also called Cord blood sample / Blood analyse
Medical abortion performed according to standard practice with cord blood sample (1 to 10ml) collected on EDTA tube before injection of foeto toxic agent.
EDTA tube transfered to laboratory on ambient temperature. Blood sample will be centrifuged to isolate the extracellular vesicles once in the laboratory.
Foetopathology examOther
Also called Sampling of myocardial tissue and vascular segments
Foetopathology exam is performed according to standard practice on the day after abortion (H12 to H48 from foetus death).
Investigator will recover 2 horizontal slices (in line with the heart) between 3 and 5 mm thick, including the right and left ventricles put them in a cold physiological saline solution, and transfer them rapidly to the laboratory.
Investigator will also recover segments of the descending aorta (approximately 2cm, between the ductus arteriosus and the celiac trunk) and the left renal artery. The isolated segments will be separated from the fat and connective tissue by the foetopathology team and put in a cold physiological saline solution.
Outcomes mesurementOther
- From the myocardial samples, 10 µm thick sections will be prepared and slides will be incubated with antibodies directed against proteins of interest (adrenergic receptors, protein kinase A, ryanodine receptor, PDE3, troponin). After washing, fluorescent secondary antibodies will be used and slides will be observed under a fluorescence microscope. Rest of the cardiac tissue will be frozen in liquid nitrogen in order to perform Western blots.
- Vessel samples will be put in a myograph to study contractile function. Concentration-response curves will be constructed by cumulative application of noradrenaline or U46619. For the study of endothelial function, arteries with and without functional endothelium will be pre-contracted to 80% of maximal contraction with U46619. When contraction reaches a plate, cumulative addition of different vasodilating agents will be performed. The vessels will also be cannulated on an arteriograph to assess dilation in response to flow and myogenic tone.
| Study group | Role | What they receive |
|---|---|---|
| Extremely low gestational age foetuses | Material (cord blood/myocardial tissu/ vascular segment) from foetuses resulting from medical abortion before 28 weeks of gestation (and after 22 weeks of gestation) Receives: Other: Medical abortion; Other: Foetopathology exam; Other: Outcomes mesurement | |
| Control group : foetuses ≥ 34 weeks of gestation | Material (cord blood/myocardial tissu/ vascular segment) from foetuses resulting from medical abortion after or during 34 weeks of gestation Receives: Other: Medical abortion; Other: Foetopathology exam; Other: Outcomes mesurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the quantity of beta adrenergic receptor linked to myocardial contraction according to the term of foetal death
Comparison between the two groups of beta-adrenergic receptor
- ß-adrenergic receptor levels: ß-adrenergic expression / GAPDH (Glyceraldehyde-3-phosphate dehydrogenase) expression. Expressed as a percentage
Measured: After foetopathology exam within 48 hours of the abortion
Comparison of the quantity of phosphodiesterase 3 linked to myocardial contraction according to the term of foetal death
Comparison between the two groups of the quantity of phosphodiesterase 3 (PDE3) :
- Phosphodiesterase 3 levels: PDE3 expression / Glyceraldehyde-3-phosphate dehydrogenase (GAPDH) expression. Expressed as a percentage
Measured: After foetopathology exam within 48 hours of the abortion
Secondary outcomes (11)
Comparison of the quantity of cyclic AMP linked to myocardial contraction according to the term of foetal death
Comparison between the two groups of quantity of cyclic AMP (adenosine monophosphate) levels. Expressed in pm/mL.
Measured: After foetopathology exam within 48 hours of the abortion
Comparison of the quantity of protein kinase A linked to myocardial contraction according to the term of foetal death
Comparison between the two groups of the quantity of protein kinase A levels. Expressed in U/mL.
Measured: After foetopathology exam within 48 hours of the abortion
Comparison of the quantity of type 2 ryanodine receptor linked to myocardial contraction according to the term of foetal death
Comparison between the two groups of the type 2 Ryanodine receptor levels (RyR2): RyR 2 expression / Glyceraldehyde-3-phosphate dehydrogenase (GAPDH) expression. Expressed as a percentage
Measured: After foetopathology exam within 48 hours of the abortion
Comparison of the quantity of troponin linked to myocardial contraction according to the term of foetal death
Comparison between the two groups of the troponin levels (troponin I, C and T): Troponin expression / Glyceraldehyde-3-phosphate dehydrogenase (GAPDH) expression. Expressed as a percentage
Measured: After foetopathology exam within 48 hours of the abortion
Comparison of the vascular response of smooth muscle according to the term of foetal death
Comparison between the two groups of vascular response on the aorta and renal artery: smooth muscle contractile function. Expressed in mN/mm
Measured: After foetopathology exam within 48 hours of the abortion
Comparison of the vascular response of myogenic tone according to the term of foetal death
Comparison between the two groups of vascular response on the aorta and renal artery: myogenic tone. Expressed in um
Measured: After foetopathology exam within 48 hours of the abortion
Comparison of the vascular response of endothelial function according to the term of foetal death
Comparison between the two groups of vascular response on the aorta and renal artery: endothelial function. Expressed as percentage
Measured: After foetopathology exam within 48 hours of the abortion
Comparison of the myocardial architecture according to the term of foetal death
Comparison between the two groups of myocardial architecture.
Measured: After foetopathology exam within 48 hours of the abortion
Comparison of the vasoactive agents level in blood according to the term of foetal death
Comparison between the two groups of vasoactive agents level by measuring the level of extracellular vesicles in cord blood. Expressed as a percentage.
Measured: Within 48 hours of the abortion
Comparison of the vascular alpha adrenergic receptor levels according to the term of foetal death
Comparison between the two groups of alpha adrenergic receptor levels on vascular segment (percentage)
Measured: After foetopathology exam within 48 hours of the abortion
Comparison of the cytosolic and mitochondrial oxidative stress according to the term of foetal death
Comparison between the two groups of cytosolic and mitochondrial oxidative stress (0-100)
Measured: After foetopathology exam within 48 hours of the abortion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for ELGAN (22-28SA)Studies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM U1046 Physiologie et médecine expérimentale du coeur et des muscles
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737965
- Sponsor's protocol ID
- RECHMPL24_0118
- Other IDs
- AO Tremplin
- Acronym
- ELGAN AMINES
- Status last verified
- Oct 2024
- First submitted
- 12 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Publications
Osborn DA, Paradisis M, Evans N. The effect of inotropes on morbidity and mortality in preterm infants with low systemic or organ blood flow. Cochrane Database Syst Rev. 2007 Jan 24;2007(1):CD005090. doi: 10.1002/14651858.CD005090.pub2.
PubMed 17253539Subhedar NV, Shaw NJ. Dopamine versus dobutamine for hypotensive preterm infants. Cochrane Database Syst Rev. 2003;(3):CD001242. doi: 10.1002/14651858.CD001242.
PubMed 12917901Raschetti R, Torchin H, Marchand-Martin L, Gascoin G, Cambonie G, Brissaud O, Roze JC, Storme L, Ancel PY, Mekontso-Dessap A, Durrmeyer X. In-hospital Outcomes and Early Hemodynamic Management According to Echocardiography Use in Hypotensive Preterm Infants: A National Propensity-Matched Cohort Study. Front Cardiovasc Med. 2022 Jul 14;9:852666. doi: 10.3389/fcvm.2022.852666. eCollection 2022.
PubMed 35911541Roze JC, Cambonie G, Marchand-Martin L, Gournay V, Durrmeyer X, Durox M, Storme L, Porcher R, Ancel PY; Hemodynamic EPIPAGE 2 Study Group. Association Between Early Screening for Patent Ductus Arteriosus and In-Hospital Mortality Among Extremely Preterm Infants. JAMA. 2015 Jun 23-30;313(24):2441-8. doi: 10.1001/jama.2015.6734.
PubMed 26103028Mertens L, Seri I, Marek J, Arlettaz R, Barker P, McNamara P, Moon-Grady AJ, Coon PD, Noori S, Simpson J, Lai WW; Writing Group of the American Society of Echocardiography; European Association of Echocardiography; Association for European Pediatric Cardiologists. Targeted Neonatal Echocardiography in the Neonatal Intensive Care Unit: practice guidelines and recommendations for training. Writing Group of the American Society of Echocardiography (ASE) in collaboration with the European Association of Echocardiography (EAE) and the Association for European Pediatric Cardiologists (AEPC). J Am Soc Echocardiogr. 2011 Oct;24(10):1057-78. doi: 10.1016/j.echo.2011.07.014. No abstract available.
PubMed 21933743de Waal K, Evans N. Hemodynamics in preterm infants with late-onset sepsis. J Pediatr. 2010 Jun;156(6):918-922.e1. doi: 10.1016/j.jpeds.2009.12.026. Epub 2010 Mar 16.
PubMed 20236658Batton B, Li L, Newman NS, Das A, Watterberg KL, Yoder BA, Faix RG, Laughon MM, Stoll BJ, Van Meurs KP, Carlo WA, Poindexter BB, Bell EF, Sanchez PJ, Ehrenkranz RA, Goldberg RN, Laptook AR, Kennedy KA, Frantz ID 3rd, Shankaran S, Schibler K, Higgins RD, Walsh MC; Eunice Kennedy Shriver National Institute of Child Health & Human Development Neonatal Research Network. Use of antihypotensive therapies in extremely preterm infants. Pediatrics. 2013 Jun;131(6):e1865-73. doi: 10.1542/peds.2012-2779. Epub 2013 May 6.
PubMed 23650301Giesinger RE, Rios DR, Chatmethakul T, Bischoff AR, Sandgren JA, Cunningham A, Beauchene M, Stanford AH, Klein JM, Ten Eyck P, McNamara PJ. Impact of Early Hemodynamic Screening on Extremely Preterm Outcomes in a High-Performance Center. Am J Respir Crit Care Med. 2023 Aug 1;208(3):290-300. doi: 10.1164/rccm.202212-2291OC.
PubMed 37209133Aldana-Aguirre JC, Deshpande P, Jain A, Weisz DE. Physiology of Low Blood Pressure During the First Day After Birth Among Extremely Preterm Neonates. J Pediatr. 2021 Sep;236:40-46.e3. doi: 10.1016/j.jpeds.2021.05.026. Epub 2021 May 18.
PubMed 34019882Sakurai K, Takeba Y, Osada Y, Mizuno M, Tsuzuki Y, Aso K, Kida K, Ohta Y, Ootaki M, Iiri T, Hokuto I, Shimizu N, Matsumoto N. Antenatal Glucocorticoid Administration Promotes Cardiac Structure and Energy Metabolism Maturation in Preterm Fetuses. Int J Mol Sci. 2022 Sep 5;23(17):10186. doi: 10.3390/ijms231710186.
PubMed 36077580Osborn DA, Evans N, Kluckow M. Left ventricular contractility in extremely premature infants in the first day and response to inotropes. Pediatr Res. 2007 Mar;61(3):335-40. doi: 10.1203/pdr.0b013e318030d1e1.
PubMed 17314693Seidler AL, Gyte GML, Rabe H, Diaz-Rossello JL, Duley L, Aziz K, Testoni Costa-Nobre D, Davis PG, Schmolzer GM, Ovelman C, Askie LM, Soll R; INTERNATIONAL LIAISON COMMITTEE ON RESUSCITATION NEONATAL LIFE SUPPORT TASK FORCE. Umbilical Cord Management for Newborns <34 Weeks' Gestation: A Meta-analysis. Pediatrics. 2021 Mar;147(3):e20200576. doi: 10.1542/peds.2020-0576.
PubMed 33632931Kluckow M, Evans N. Low superior vena cava flow and intraventricular haemorrhage in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2000 May;82(3):F188-94. doi: 10.1136/fn.82.3.f188.
PubMed 10794784Hunt RW, Evans N, Rieger I, Kluckow M. Low superior vena cava flow and neurodevelopment at 3 years in very preterm infants. J Pediatr. 2004 Nov;145(5):588-92. doi: 10.1016/j.jpeds.2004.06.056.
PubMed 15520755Treluyer L, Chevallier M, Jarreau PH, Baud O, Benhammou V, Gire C, Marchand-Martin L, Marret S, Pierrat V, Ancel PY, Torchin H. Intraventricular Hemorrhage in Very Preterm Children: Mortality and Neurodevelopment at Age 5. Pediatrics. 2023 Apr 1;151(4):e2022059138. doi: 10.1542/peds.2022-059138.
PubMed 36919442
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Immaturity in Extremely Low Gestational Age Newborns: a Fundamental Prospective Study
- ClinicalTrials.gov ID
- NCT06737965
- Acronym / sponsor ID
- ELGAN AMINES / RECHMPL24_0118
- Keywords
- Cardiovascular immaturity in extremely premature infants, vasoactive agent, vascular reactivity, cardiac adrenergic receptor, cardiac architecture, vascular response, Extremely low gestational age newborns, cardio-circulatory insufficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- INSERM U1046 Physiologie et médecine expérimentale du coeur et des muscles
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Dec 2024 (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.
Birth is a major turning point in the life of the newborn, as it moves from intrauterine life to extrauterine life. This sudden transition forces the newborn to adapt quickly. Oxygenation, which was only provided by the placenta during uterine life, will have to be provided by the lungs, which will open when the newborn cries for the first time. This phenomenon will change the way blood reaches the lungs and will require the newborn's heart to work harder. In addition, the cardiac workload will also increase due to the clamping of the umbilical cord, which will force the heart to pump through more resistant blood vessels.
This transition, generally well tolerated in newborns at term, can be much more complicated in premature newborns, particularly in extremely low gestational age newborns (e.g. ELGAN, born before 28 weeks of amenorrhoea). There are several causes of this difficult adaptation on the cardiovascular system: poor heart function, difficulty in revascularizing lungs due to the physiological characteristics of premature newborns (high pulmonary vascular resistance, persistence of the ductus arteriosus), and a tone of the blood vessel muscles that is probably immature. In addition, respiratory failure is often associated with pulmonary immaturity.
The consequences of a difficult adaptation to extrauterine life, combined with cardiovascular failure, will be poor organ perfusion, whose brain. Moreover, ELGANs have immature regulation of their brain vascularisation. Variations in the vascularisation of the brain (in the event of cardiovascular failure) may be responsible for irreversible lesions with intraventricular hemorrhage. Ultimately, these bleedings carry a high risk of mortality or severe disability in premature infants.
Several hypotheses have been put forward as to the causes of this poor adaptation to extrauterine life, but there are few recommendations on adapted medical management. Cardiac ultrasound and the use of drugs to support the heart and blood vessels have been suggested. However, a large number of ELGANs will develop complications that investigators cannot predict or intervene in time. In addition, studies on the drugs used have not been carried out on ELGANs, which limits the conclusions investigators can draw.
These factors encourage us to improve our fundamental knowledge of the cardiovascular system in the ELGANs. The aim is to identify the most effective clinical tools and treatments for assessing and treating neonatal cardiovascular failure at an early stage, before complications appear. Investigators aim to compare the architecture and composition of the heart, blood vessels, and blood of fetuses under 28 weeks of amenorrhea gestation with those of fetuses over or equal to 34 weeks of amenorrhea gestation.
For this research, investigators need tissues (heart muscle, blood, and vessels) from fetuses of different ages. These tissues are usually already taken during the foetopathology examination to try to provide a medical explanation of the medical abortion. There will be no change to the foetopathology examination carried out on the foetus, with the exception that some of the tissue taken will have additional analyses carried out in our INSERM laboratory attached to the Montpellier University Hospital.
Population resulting from medical abortion is motivated by the ethical impossibility of taking such invasive samples from live newborns. The non-use of animals is justified by the difficulty of extrapolating results to humans. The indication for abortion and its performance will be carried out by current practice. Participants will be offered and explained the study during the pre abortion visit.
This research does not alter the patient's care. No additional examination or consultation is required. No personal benefit is expected from the study, but it will enable us to gain a better understanding of ELGAN's hemodynamics and to consider future clinical studies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extremely low gestational age foetuses | – | Other: Medical abortion, Other: Foetopathology exam, Other: Outcomes mesurementMaterial (cord blood/myocardial tissu/ vascular segment) from foetuses resulting from medical abortion before 28 weeks of gestation (and after 22 weeks of gestation) |
| Control group : foetuses ≥ 34 weeks of gestation | – | Other: Medical abortion, Other: Foetopathology exam, Other: Outcomes mesurementMaterial (cord blood/myocardial tissu/ vascular segment) from foetuses resulting from medical abortion after or during 34 weeks of gestation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All pregnant woman who will receive a medical abortion at Montpellier Hospital and who present eligibility criteria for her and her foetus will be invited to participate to the study
Key inclusion criteria (8 listed)
- Over 18 years old.
- Speaks and understands French.
- Medical abortion requested by the participant, scheduled and validated by the CPDPN of the Montpellier University Hospital.
- Participant's agreement to use for research purposes the biological tissues from the systematic foetopathological examination.
- Interest group: Fœtus ≥ 22 WA and <28 WA
Key exclusion criteria (12 listed)
- Injection of betamethasone or maternal use of dexamethasone in the month before foeticide
- Known family genetic mutation that may be linked with cardiomyopathy
- Failure to obtain consent (adults, unemancipated minors, persons unable to give consent)
- Not affiliated to a social security
- Persons under legal protection
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 |
|---|---|---|
| Medical abortionAlso: Cord blood sample / Blood analyseMedical abortion performed according to standard practice with cord blood sample (1 to 10ml) collected on EDTA tube before injection of foeto toxic agent. EDTA tube transfered to laboratory on ambient temperature. Blood sample will be centrifuged to isolate the extracellular vesicles once in the laboratory. | Other | Control group : foetuses ≥ 34 weeks of gestation, Extremely low gestational age foetuses |
| Foetopathology examAlso: Sampling of myocardial tissue and vascular segmentsFoetopathology exam is performed according to standard practice on the day after abortion (H12 to H48 from foetus death). Investigator will recover 2 horizontal slices (in line with the heart) between 3 and 5 mm thick, including the right and left ventricles put them in a cold physiological saline solution, and transfer them rapidly to the laboratory. Investigator will also recover segments of the descending aorta (approximately 2cm, between the ductus arteriosus and the celiac trunk) and the left renal artery. The isolated segments will be separated from the fat and connective tissue by the foetopathology team and put in a cold physiological saline solution. | Other | Control group : foetuses ≥ 34 weeks of gestation, Extremely low gestational age foetuses |
| Outcomes mesurement* From the myocardial samples, 10 µm thick sections will be prepared and slides will be incubated with antibodies directed against proteins of interest (adrenergic receptors, protein kinase A, ryanodine receptor, PDE3, troponin). After washing, fluorescent secondary antibodies will be used and slides will be observed under a fluorescence microscope. Rest of the cardiac tissue will be frozen in liquid nitrogen in order to perform Western blots. * Vessel samples will be put in a myograph to study contractile function. Concentration-response curves will be constructed by cumulative application of noradrenaline or U46619. For the study of endothelial function, arteries with and without functional endothelium will be pre-contracted to 80% of maximal contraction with U46619. When contraction reaches a plate, cumulative addition of different vasodilating agents will be performed. The vessels will also be cannulated on an arteriograph to assess dilation in response to flow and myogenic tone. | Other | Control group : foetuses ≥ 34 weeks of gestation, Extremely low gestational age foetuses |
Primary outcome
Comparison of the quantity of beta adrenergic receptor linked to myocardial contraction according to the term of foetal death
Time frame: After foetopathology exam within 48 hours of the abortion
Comparison between the two groups of beta-adrenergic receptor - ß-adrenergic receptor levels: ß-adrenergic expression / GAPDH (Glyceraldehyde-3-phosphate dehydrogenase) expression. Expressed as a percentage
Comparison of the quantity of phosphodiesterase 3 linked to myocardial contraction according to the term of foetal death
Time frame: After foetopathology exam within 48 hours of the abortion
Comparison between the two groups of the quantity of phosphodiesterase 3 (PDE3) : - Phosphodiesterase 3 levels: PDE3 expression / Glyceraldehyde-3-phosphate dehydrogenase (GAPDH) expression. Expressed as a percentage
11 secondary outcomes
Comparison of the quantity of cyclic AMP linked to myocardial contraction according to the term of foetal death
Time frame: After foetopathology exam within 48 hours of the abortion
Comparison of the quantity of protein kinase A linked to myocardial contraction according to the term of foetal death
Time frame: After foetopathology exam within 48 hours of the abortion
Comparison of the quantity of type 2 ryanodine receptor linked to myocardial contraction according to the term of foetal death
Time frame: After foetopathology exam within 48 hours of the abortion
Comparison of the quantity of troponin linked to myocardial contraction according to the term of foetal death
Time frame: After foetopathology exam within 48 hours of the abortion
Comparison of the vascular response of smooth muscle according to the term of foetal death
Time frame: After foetopathology exam within 48 hours of the abortion
Comparison of the vascular response of myogenic tone according to the term of foetal death
Time frame: After foetopathology exam within 48 hours of the abortion
Comparison of the vascular response of endothelial function according to the term of foetal death
Time frame: After foetopathology exam within 48 hours of the abortion
Comparison of the myocardial architecture according to the term of foetal death
Time frame: After foetopathology exam within 48 hours of the abortion
Comparison of the vasoactive agents level in blood according to the term of foetal death
Time frame: Within 48 hours of the abortion
Comparison of the vascular alpha adrenergic receptor levels according to the term of foetal death
Time frame: After foetopathology exam within 48 hours of the abortion
Comparison of the cytosolic and mitochondrial oxidative stress according to the term of foetal death
Time frame: After foetopathology exam within 48 hours of the abortion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Background: PubMed 17253539Osborn DA, Paradisis M, Evans N. The effect of inotropes on morbidity and mortality in preterm infants with low systemic or organ blood flow. Cochrane Database Syst Rev. 2007 Jan 24;2007(1):CD005090. doi: 10.1002/14651858.CD005090.pub2.
- Background: PubMed 12917901Subhedar NV, Shaw NJ. Dopamine versus dobutamine for hypotensive preterm infants. Cochrane Database Syst Rev. 2003;(3):CD001242. doi: 10.1002/14651858.CD001242.
- Background: PubMed 35911541Raschetti R, Torchin H, Marchand-Martin L, Gascoin G, Cambonie G, Brissaud O, Roze JC, Storme L, Ancel PY, Mekontso-Dessap A, Durrmeyer X. In-hospital Outcomes and Early Hemodynamic Management According to Echocardiography Use in Hypotensive Preterm Infants: A National Propensity-Matched Cohort Study. Front Cardiovasc Med. 2022 Jul 14;9:852666. doi: 10.3389/fcvm.2022.852666. eCollection 2022.
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- Individual participant dataSharing planned: Yes. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
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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.
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 ELGAN (22-28SA) and Extremely Low Gestational Age Newborns, run by University Hospital, Montpellier 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 8 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: status not confirmed, as of the sponsor's last update on 17 Dec 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arthur Gavotto, Doctor (+33 04 67 33 66 09, a-gavotto@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the quantity of beta adrenergic receptor linked to myocardial contraction according to the term of foetal death (time frame: After foetopathology exam within 48 hours of the abortion). The study lists 2 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 NCT06737965, which also lists 25 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 17 Dec 2024.