Preeclampsia and Intrauterine Growth RestrictionNCT03860103
Placental Insufficiency Microcirculation Quantification by Ultrafast Doppler (MICRODOPPLER PLACENTA)
An observational study of Preeclampsia and Intrauterine Growth Restriction, run by Nantes University Hospital at 1 site in France.
Trial summary
To identify fetuses small for their gestational-age who have reached their appropriate growth potential from growth-restricted fetuses due to placental insufficiency is uneasy. Intra Uterine Growth Restriction (IUGR) increases the risk for indicated preterm delivery, neonatal mortality and morbidity. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia and Intrauterine Growth Restriction
- How many people
- 165 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2019to 16 Mar 2022
- 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 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women
Who may be able to join
- Patient who accepted to participate in the study
- Woman over 18 years old
- Affiliated to a social security scheme
- Mono-fetal pregnancy
- Patients with normal pregnancy between 11 and 42 weeks of amenorrhea
- Patients hospitalized for preeclampsia and / or intrauterine growth retardation, beyond 20 weeks of amenorrhea
Who cannot join
- Minors, adults under guardianship, protected persons
- Not affiliated to a social security scheme
- Multiple pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Placental Insufficiency Microcirculation Quantification by Ultrafast Doppler: an Observational Prospective Study
To identify fetuses small for their gestational-age who have reached their appropriate growth potential from growth-restricted fetuses due to placental insufficiency is uneasy. Intra Uterine Growth Restriction (IUGR) increases the risk for indicated preterm delivery, neonatal mortality and morbidity. Therefore, improving the knowledge of the placental perfusion is essential to better identify and manage fetal chronic oxygen deprivation associated with placental insufficiency. Thus, the investigators propose to study placental microcirculation with a more efficient Doppler than conventional Doppler use in clinical practice. The Ultrafast Doppler is being able to map placental blood flow and could have potential impact in placental insufficiency diagnosis and prevention. Moreover, this Doppler could discriminate maternal and fetal vascularization.
The hypothesis is that Ultrafast Doppler could help clinician to diagnose and manage preeclampsia and IUGR during pregnancy.
- Keywords
- microDoppler, placenta, preeclampsia, intrauterine growth restriction
- Medical subject headings
- Pre-Eclampsia, Fetal Growth Retardation
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative analysis (velocities) of intraplacental blood flow after acquisition of sequences in Ultrafast Doppler imaging
Measured: from the 12 week of gestation
Quantitative analysis (flow rates) of intraplacental blood flow after acquisition of sequences in Ultrafast Doppler
Measured: from the 12 week of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start1 Apr 2019
- Primary completion16 Mar 2022
- Study completion16 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preeclampsia and Intrauterine Growth RestrictionStudies of the same condition, open and under way.
- 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
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860103
- Sponsor's protocol ID
- RC19_0049
- Status last verified
- Mar 2022
- First submitted
- 27 Feb 2019
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placental Insufficiency Microcirculation Quantification by Ultrafast Doppler: an Observational Prospective Study
- ClinicalTrials.gov ID
- NCT03860103
- Acronym / sponsor ID
- RC19_0049
- Keywords
- microDoppler, placenta, preeclampsia, intrauterine growth restriction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 16 Mar 2022 (actual)
- First posted
- 1 Mar 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.
To identify fetuses small for their gestational-age who have reached their appropriate growth potential from growth-restricted fetuses due to placental insufficiency is uneasy. Intra Uterine Growth Restriction (IUGR) increases the risk for indicated preterm delivery, neonatal mortality and morbidity. Therefore, improving the knowledge of the placental perfusion is essential to better identify and manage fetal chronic oxygen deprivation associated with placental insufficiency. Thus, the investigators propose to study placental microcirculation with a more efficient Doppler than conventional Doppler use in clinical practice. The Ultrafast Doppler is being able to map placental blood flow and could have potential impact in placental insufficiency diagnosis and prevention. Moreover, this Doppler could discriminate maternal and fetal vascularization.
The hypothesis is that Ultrafast Doppler could help clinician to diagnose and manage preeclampsia and IUGR during pregnancy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women
Key inclusion criteria (6 listed)
- Patient who accepted to participate in the study
- Woman over 18 years old
- Affiliated to a social security scheme
- Mono-fetal pregnancy
- Patients with normal pregnancy between 11 and 42 weeks of amenorrhea
Key exclusion criteria (3 listed)
- Minors, adults under guardianship, protected persons
- Not affiliated to a social security scheme
- Multiple pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Qualitative analysis (velocities) of intraplacental blood flow after acquisition of sequences in Ultrafast Doppler imaging
Time frame: from the 12 week of gestation
Quantitative analysis (flow rates) of intraplacental blood flow after acquisition of sequences in Ultrafast Doppler
Time frame: from the 12 week of gestation
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 17 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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 Preeclampsia and Intrauterine Growth Restriction, run by Nantes University Hospital 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 6 inclusion and 3 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 17 Mar 2022. 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?
Qualitative analysis (velocities) of intraplacental blood flow after acquisition of sequences in Ultrafast Doppler imaging (time frame: from the 12 week of gestation). 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?
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 Mar 2022.