IUGRf-ISI-RCIUNCT02813525
Ultrasound Monitoring of Fetuses With Vascular Intra-uterine Growth Restriction (IUGR) Using the Isthmus Systolic Index (ISI): Feasibility, Comparison to Normal Fetuses and Association With Perinatal Mortality
An observational study of IUGR, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Fetuses with IUGR, there is a correlation between Doppler indices of cardiovascular function and perinatal mortality. An index of systolic flow velocities at the aortic isthmus (ISI) has previously been described in a population of normal fetuses. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- IUGR
- What is being tested?
- ISI index on Doppler systolic flow in the aortic isthmus
- How many people
- 320 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2016to Sep 2018
- 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: Patients with vascular IURG fetuses and patients with non-IUGR fetuses.
Who may be able to join
- Gestational age determined by ultrasound dating of the first quarter
- IUGR group: estimated fetal weight <10th percentile associated with
- An abnormal umbilical artery Doppler with pulsatility index >95th percentile
- OR a confirmation of placental vascular disease by histological examination
- CONTROL group: non IUGR fetuses for gestational age (normal for weight, Doppler, and structural analyse)
Who cannot join
- Twin or multiple pregnancy,
- Fetal weight> 10th percentile
- Presence of fetal infection
- Structural fetal anomaly or fetal chromosomal abnormality
Trial locations and contacts
1 site in 1 country.
France1 site
Service de gynécologie-obstétrique et de médecine fœtale
Bordeaux
Julie THOMAS, MD, (0)5 57 65 61 09 ext. +33, julie.thomas@chu-bordeaux.fr
Lorena SANCHEZ BLANCO, (0)557656110 ext. +33, lorena.sanchez-blanco@chu-bordeaux.fr
About this study
Fetuses with IUGR, there is a correlation between Doppler indices of cardiovascular function and perinatal mortality. An index of systolic flow velocities at the aortic isthmus (ISI) has previously been described in a population of normal fetuses. Fetuses with IUGR, the velocities recorded in the aortic isthmus could be affected and the normal development of the ISI should be changed, because of the increase in placental resistance on one hand, and the gradual deterioration ventricular functions on the other one. Investigators hypothesize that the ISI index in the context of placental insufficiency could provide additional arguments on the extraction timing, the prognosis and the fetal extraction mode to severe hypoxia. The primary outcome of the study is to evaluate in an exploratory manner the feasibility and the potential interest of longitudinal monitoring of fetuses with IUGR by Doppler systolic isthmus and the calculation of the ISI index.
Read the detailed description
Today evaluating the hemodynamic tolerance of the fetus with IUGR, is based on clinical evidence of fetal well-being and ultrasound arguments, since we know in fact that there is a correlation between Doppler indices of cardiovascular function and perinatal mortality.
The flow to the systolic aortic isthmus may be a marker of systolic performance balance of both ventricles. An index of systolic flow velocities (ISI) has previously been described in a population of normal fetuses. Fetuses with IUGR, the velocities recorded in the aortic isthmus could be affected and the normal development of the ISI should be changed, because of the increase in placental resistance on one hand, and the gradual deterioration ventricular functions on the other one. Investigators hypothesize that the ISI index in the context of placental insufficiency could provide additional arguments on the extraction timing, the prognosis and the fetal extraction mode to severe hypoxia.
The strategy evaluates the feasibility of measuring the ISI index on Doppler systolic flow in the aortic isthmus in the follow-up by ultrasound of the fetus with IUGR due to placental insufficiency.
The ISI is obtained from this flow by calculating the ratio of the minimum systolic velocity (called Nadir) on the peak systolic velocity (called Peak) or Nadir / Peak. The fetal extraction decision (birth) will be taken, blinded the outcome of the ISI, following the protocol of national recommendations for the management of fetuses with IUGR.
- Conditions
- IUGR
- Being tested
- ISI index on Doppler systolic flow in the aortic isthmus
- Keywords
- Aortic Isthmus, Isthmic Systolic Index, feasibility, reproducibility, mortality, delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISI index on Doppler systolic flow in the aortic isthmusOther
Measure of the ISI index on Doppler systolic flow in the aortic isthmus in the follow-up by ultrasound of the fetus
| Study group | Role | What they receive |
|---|---|---|
| IUGR group | estimated fetal weight <10th percentile associated with an abnormal umbilical artery Doppler with IP>95th percentile or a confirmation of placental vascular disease by histological examination Receives: Other: ISI index on Doppler systolic flow in the aortic isthmus | |
| CONTROL group | non IUGR fetuses for gestational age (normal for weight, Doppler, and structural analyse) Receives: Other: ISI index on Doppler systolic flow in the aortic isthmus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the evolution of the values of the ISI in the fetus with IUGR relative to those of fetuses without IUGR fetuses for the same gestational age
Measured: Up to 3 months
Secondary outcomes (3)
Assess the feasibility of the Doppler and the measure of the parameter
- Obtaining of the sagittal cup or the cross-functional cup of the aortic arch (conformity : yes/no, obtaining: very easy, easy, little easy, difficult, very difficult, impossible).
- Positioning of the shooting doppler: very easy, easy, little easy, difficult, very difficult, impossible.
- Doppler flow for the isthmus: conformity yes/no.
- ISI Measure : very easy, easy, little easy, difficult, very difficult, impossible·
- Time necessary to obtain the measure (including obtaining of the cup of the aortic arch in sagittal or cross-functional and the measure of the velocities on the Doppler flow).
Measured: Up to 3 months
Compare the reproducibility of the measurement between sonographers with different levels of expertise
Measured: Up to 3 months
Estimate the association between ISI index and perinatal mortality and the performance of the ISI in predicting perinatal mortality
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IUGRStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul PEREZ, MD, Study chair, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813525
- Sponsor's protocol ID
- CHUBX 2014/16
- Acronym
- f-ISI-RCIU
- Status last verified
- Jun 2016
- First submitted
- 15 Jun 2016
- Last updated
- 27 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Monitoring of Fetuses With Vascular Intra-uterine Growth Restriction (IUGR) Using the Isthmus Systolic Index (ISI): Feasibility, Comparison to Normal Fetuses and Association With Perinatal Mortality
- ClinicalTrials.gov ID
- NCT02813525
- Acronym / sponsor ID
- f-ISI-RCIU / CHUBX 2014/16
- Conditions
- IUGR
- Keywords
- Aortic Isthmus, Isthmic Systolic Index, feasibility, reproducibility, mortality, delivery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 27 Jun 2016 (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.
Fetuses with IUGR, there is a correlation between Doppler indices of cardiovascular function and perinatal mortality. An index of systolic flow velocities at the aortic isthmus (ISI) has previously been described in a population of normal fetuses. Fetuses with IUGR, the velocities recorded in the aortic isthmus could be affected and the normal development of the ISI should be changed, because of the increase in placental resistance on one hand, and the gradual deterioration ventricular functions on the other one. Investigators hypothesize that the ISI index in the context of placental insufficiency could provide additional arguments on the extraction timing, the prognosis and the fetal extraction mode to severe hypoxia. The primary outcome of the study is to evaluate in an exploratory manner the feasibility and the potential interest of longitudinal monitoring of fetuses with IUGR by Doppler systolic isthmus and the calculation of the ISI index.
Detailed description
Today evaluating the hemodynamic tolerance of the fetus with IUGR, is based on clinical evidence of fetal well-being and ultrasound arguments, since we know in fact that there is a correlation between Doppler indices of cardiovascular function and perinatal mortality.
The flow to the systolic aortic isthmus may be a marker of systolic performance balance of both ventricles. An index of systolic flow velocities (ISI) has previously been described in a population of normal fetuses. Fetuses with IUGR, the velocities recorded in the aortic isthmus could be affected and the normal development of the ISI should be changed, because of the increase in placental resistance on one hand, and the gradual deterioration ventricular functions on the other one. Investigators hypothesize that the ISI index in the context of placental insufficiency could provide additional arguments on the extraction timing, the prognosis and the fetal extraction mode to severe hypoxia.
The strategy evaluates the feasibility of measuring the ISI index on Doppler systolic flow in the aortic isthmus in the follow-up by ultrasound of the fetus with IUGR due to placental insufficiency.
The ISI is obtained from this flow by calculating the ratio of the minimum systolic velocity (called Nadir) on the peak systolic velocity (called Peak) or Nadir / Peak. The fetal extraction decision (birth) will be taken, blinded the outcome of the ISI, following the protocol of national recommendations for the management of fetuses with IUGR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IUGR group | – | Other: ISI index on Doppler systolic flow in the aortic isthmusestimated fetal weight <10th percentile associated with an abnormal umbilical artery Doppler with IP>95th percentile or a confirmation of placental vascular disease by histological examination |
| CONTROL group | – | Other: ISI index on Doppler systolic flow in the aortic isthmusnon IUGR fetuses for gestational age (normal for weight, Doppler, and structural analyse) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with vascular IURG fetuses and patients with non-IUGR fetuses.
Key inclusion criteria (5 listed)
- Gestational age determined by ultrasound dating of the first quarter
- IUGR group: estimated fetal weight <10th percentile associated with
- CONTROL group: non IUGR fetuses for gestational age (normal for weight, Doppler, and structural analyse)
Key exclusion criteria (4 listed)
- Twin or multiple pregnancy,
- Fetal weight> 10th percentile
- Presence of fetal infection
- Structural fetal anomaly or fetal chromosomal abnormality
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 |
|---|---|---|
| ISI index on Doppler systolic flow in the aortic isthmusMeasure of the ISI index on Doppler systolic flow in the aortic isthmus in the follow-up by ultrasound of the fetus | Other | CONTROL group, IUGR group |
Primary outcome
Compare the evolution of the values of the ISI in the fetus with IUGR relative to those of fetuses without IUGR fetuses for the same gestational age
Time frame: Up to 3 months
3 secondary outcomes
Assess the feasibility of the Doppler and the measure of the parameter
Time frame: Up to 3 months
Compare the reproducibility of the measurement between sonographers with different levels of expertise
Time frame: Up to 3 months
Estimate the association between ISI index and perinatal mortality and the performance of the ISI in predicting perinatal mortality
Time frame: Up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2016.
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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.
Paul PEREZ, MD study chair
University Hospital Bordeaux, 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 IUGR, run by University Hospital, Bordeaux 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 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: status not confirmed, as of the sponsor's last update on 27 Jun 2016. 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 Julie THOMAS, MD ((0)557656109 ext. +33, julie.thomas@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the evolution of the values of the ISI in the fetus with IUGR relative to those of fetuses without IUGR fetuses for the same gestational age (time frame: Up to 3 months). 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 27 Jun 2016.