Placental ElastographyELASTOLabNCT05510349
Prevention of Per-partum Fetal Hypoxia: Measure of Placental Elasticity and Viscosity During Labor
A study testing Sonographic measure of placental elasticity and viscosity in people with Placental Elastography and Fetal Monitoring, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
Fetal heart rate (FHR) monitoring during labor aims to detect fetuses at risk of intrapartum hypoxia in order to accelerate their birth before the constitution of sequelae such as anoxic encephalopathy and cerebral palsy. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placental Elastography, Fetal Monitoring
- What is being tested?
- Sonographic measure of placental elasticity and viscosity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Feb 2024
- Phase
- Interventional
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- singleton pregnancy
- spontaneous labor at term
- body mass index < 30 at the beginning of the pregnancy
- anterior, lateral or fundal placenta
- epidural analgesia at the beginning of the labor
- normal fetal heart rate at the beginning of the labor
Who cannot join
- gestational diabetes
- preeclampsia
- intrauterine growth restriction
About this study
Fetal heart rate (FHR) monitoring during labor aims to detect fetuses at risk of intrapartum hypoxia in order to accelerate their birth before the constitution of sequelae such as anoxic encephalopathy and cerebral palsy. But the positive predictive value of FHR monitoring is low, and many second-line tests have been proposed but none of them has been proven to be conclusive. Measure of placental elasticity and viscosity during labor could be a new second line test to complete the FHR monitoring. Several studies have shown that placental elasticity is increased in case of gestational diabetes, preeclampsia, or intrauterine growth restriction, but no study has focused on placental elasticity during labor. The investigators hypothesize that placental elasticity and viscosity could reflect the quality of maternal-fetal exchanges during labor, and could help to detect fetus at risk of intrapartum hypoxia.
The first aim of this study is to describe the values of placental elasticity and viscosity during different points in the labor: beginning of the labor, beginning of the active phase of the first stage of labor, and passive phase of the second stage of labor.
Read more
Secondary aims of this study are: to describe the values of placental elasticity and viscosity in case of oxytocin infusion, in case of abnormal FHR, and ex-vivo after placental expulsion.
This unicentric observational prospective study will include 150 patients with singleton pregnancy, without pathology, with spontaneous labor at term.
- Conditions
- Placental Elastography, Fetal Monitoring
- Being tested
- Sonographic measure of placental elasticity and viscosity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonographic measure of placental elasticity and viscosityOther
Sonographic measure of placental elasticity and viscosity
| Study group | Role | What they receive |
|---|---|---|
| All the patients | Experimental | Sonographic measure of placental elasticity and viscosity Receives: Other: Sonographic measure of placental elasticity and viscosity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placental elasticity in kilopascals (kPa)
beginning of the labor
Measured: Day 1
Placental viscosity in Pascal.seconde (Pa.s)
beginning of the labor
Measured: Day 1
Placental elasticity in kilopascals (kPa)
beginning of the active phase of the first stage of labor
Measured: Day 1
Placental viscosity in Pascal.seconde (Pa.s)
beginning of the active phase of the first stage of labor
Measured: Day 1
Placental elasticity in kilopascals (kPa)
passive phase of the second stage of labor
Measured: Day 1
Placental viscosity in Pascal.seconde (Pa.s)
passive phase of the second stage of labor
Measured: Day 1
Secondary outcomes (6)
Placental elasticity in kilopascals (kPa)
in case of oxytocin infusion
Measured: Day 1
Placental viscosity in Pascal.seconde (Pa.s)
in case of oxytocin infusion
Measured: Day 1
Placental elasticity in kilopascals (kPa)
in case of abnormal FHR
Measured: Day 1
Placental viscosity in Pascal.seconde (Pa.s)
in case of abnormal FHR
Measured: Day 1
Placental elasticity in kilopascals (kPa)
ex-vivo after placental expulsion
Measured: Day 1
Placental viscosity in Pascal.seconde (Pa.s)
ex-vivo after placental expulsion
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study startOct 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placental ElastographyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Sonographic measure of placental elasticity and viscosity
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510349
- Sponsor's protocol ID
- 2021/652
- Acronym
- ELASTOLab
- Status last verified
- Oct 2021
- First submitted
- 8 Aug 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Per-partum Fetal Hypoxia: Measure of Placental Elasticity and Viscosity During Labor
- ClinicalTrials.gov ID
- NCT05510349
- Acronym / sponsor ID
- ELASTOLab / 2021/652
- Conditions
- Placental Elastography, Fetal Monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 22 Aug 2022 (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.
Fetal heart rate (FHR) monitoring during labor aims to detect fetuses at risk of intrapartum hypoxia in order to accelerate their birth before the constitution of sequelae such as anoxic encephalopathy and cerebral palsy. But the positive predictive value of FHR monitoring is low, and many second-line tests have been proposed but none of them has been proven to be conclusive. Measure of placental elasticity and viscosity during labor could be a new second line test to complete the FHR monitoring. Several studies have shown that placental elasticity is increased in case of gestational diabetes, preeclampsia, or intrauterine growth restriction, but no study has focused on placental elasticity during labor. The investigators hypothesize that placental elasticity and viscosity could reflect the quality of maternal-fetal exchanges during labor, and could help to detect fetus at risk of intrapartum hypoxia.
The first aim of this study is to describe the values of placental elasticity and viscosity during different points in the labor: beginning of the labor, beginning of the active phase of the first stage of labor, and passive phase of the second stage of labor.
Secondary aims of this study are: to describe the values of placental elasticity and viscosity in case of oxytocin infusion, in case of abnormal FHR, and ex-vivo after placental expulsion.
This unicentric observational prospective study will include 150 patients with singleton pregnancy, without pathology, with spontaneous labor at term.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sonographic measure of placental elasticity and viscosity
| Arm | Type | Receives |
|---|---|---|
| All the patients | Experimental | Other: Sonographic measure of placental elasticity and viscositySonographic measure of placental elasticity and viscosity |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- singleton pregnancy
- spontaneous labor at term
- body mass index < 30 at the beginning of the pregnancy
- anterior, lateral or fundal placenta
- epidural analgesia at the beginning of the labor
Key exclusion criteria (3 listed)
- gestational diabetes
- preeclampsia
- intrauterine growth restriction
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 |
|---|---|---|
| Sonographic measure of placental elasticity and viscositySonographic measure of placental elasticity and viscosity | Other | All the patients |
Primary outcome
Placental elasticity in kilopascals (kPa)
Time frame: Day 1
beginning of the labor
Placental viscosity in Pascal.seconde (Pa.s)
Time frame: Day 1
beginning of the labor
Placental elasticity in kilopascals (kPa)
Time frame: Day 1
beginning of the active phase of the first stage of labor
Placental viscosity in Pascal.seconde (Pa.s)
Time frame: Day 1
beginning of the active phase of the first stage of labor
Placental elasticity in kilopascals (kPa)
Time frame: Day 1
passive phase of the second stage of labor
Placental viscosity in Pascal.seconde (Pa.s)
Time frame: Day 1
passive phase of the second stage of labor
6 secondary outcomes
Placental elasticity in kilopascals (kPa)
Time frame: Day 1
Placental viscosity in Pascal.seconde (Pa.s)
Time frame: Day 1
Placental elasticity in kilopascals (kPa)
Time frame: Day 1
Placental viscosity in Pascal.seconde (Pa.s)
Time frame: Day 1
Placental elasticity in kilopascals (kPa)
Time frame: Day 1
Placental viscosity in Pascal.seconde (Pa.s)
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Sonographic measure of placental elasticity and viscosity in people with Placental Elastography and Fetal Monitoring, run by Centre Hospitalier Universitaire de Besancon.
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: status not confirmed, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Placental elasticity in kilopascals (kPa) (time frame: Day 1). The study lists 6 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 22 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.