Ultrasonography, DopplerNCT05599178
Doppler Findings in the Fetal Cerebral Blood Vessels (VA/MCA) Within 24 Hours Before Delivery and Relation With Perinatal Outcome.
An observational study of Ultrasonography, Doppler and Obstetric Labor Complications, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
1. Assess differences in flow patterns in the fetal cerebral blood vessels within 24 hours before delivery between fetuses with a normal vs. adverse perinatal outcome. 2. Explore maternal and/or fetal characteristics that might influence technical feasibility of doppler sonography of the fetal cerebral blood vessels… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ultrasonography, Doppler, Obstetric Labor Complications
- What is being tested?
- Ultrasound examination in early labor
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Dec 2022to 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: "Low-risk" pregnant women
Who may be able to join
- Singleton pregnancy.
- Term gestation (37-42 weeks).
- Fetus in cephalic presentation.
- No known fetal chromosomal or (severe) congenital anomaly.
- Normally grown fetus (ultrasound scan demonstrating normal fetal growth between 30-37 weeks of gestation, defined as an estimated fetal weight/abdominal circumference > 10th centile or crossing <2 quartiles compared to earlier growth ultrasound).
- Absence of pre-existing doppler or amniotic fluid abnormalities.
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- Normal fetal heart rate tracing / CTG (excluding pre-existing hypoxia).
- Admission in early spontaneous labor or induction of labor with expected delivery < 24 hours.
- Maternal age >= 18 years
- Willing to give written informed consent.
Who cannot join
- Advanced labor (> 4cm of cervical dilatation) at the time of admission on the labor ward.
- Severe pre-existing chronic maternal medical condition or poor obstetric history/antenatal complications associated with increased risk of adverse perinatal outcome (non-exhaustive e.g.: uncontrolled chronic hypertension, severe pre-eclampsia, uncontrolled (gestational) diabetes, maternal sepsis, major antepartum haemorrhage, intra-uterine infection, prolonged rupture of membranes > 18 hours, etc.).
- Intra-uterine fetal demise / death.
- Prelabour rupture of membranes with meconium-stained amniotic fluid.
- Patients not fulfilling all the inclusion criteria or refusing to give written informed consent.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven, department of obstetrics and gynaecology
Leuven, 3000
Bram Packet, MD, 00321648824
About this study
- Assess differences in flow patterns in the fetal cerebral blood vessels within 24 hours before delivery between fetuses with a normal vs. adverse perinatal outcome.
- Explore maternal and/or fetal characteristics that might influence technical feasibility of doppler sonography of the fetal cerebral blood vessels in early labor at term.
- Assess reliability of the technique by measuring intra- and inter-observer variation in a subset of participants.
- Being tested
- Ultrasound examination in early labor
- Medical subject headings
- Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound examination in early laborOther
Combined trans-abdominal and trans-perineal ultrasound examination
| Study group | Role | What they receive |
|---|---|---|
| Term gestation | Not described Receives: Other: Ultrasound examination in early labor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in VPR (Vertebro-Placental Ratio) between fetuses/neonates with a composite perinatal outcome score < 3 / => 3
Measured: VPR measured in early labor (=< 4cm of cervical dilatation) - perinatal outcome score assessed at delivery - timespan between both observations variable, expected <12 hours.
Secondary outcomes (2)
Differences in other doppler parameters (PI VA, PI MCA, CPR) between fetuses/neonates with a composite perinatal outcome score < 3 / => 3.
Measured: VPR measured in early labor (=< 4cm of cervical dilatation) - perinatal outcome score assessed at delivery - timespan between both observations variable, expected <12 hours.
Differences in maternal and fetal characteristics between successful and unsuccessful doppler examinations (observations) of the fetal VA and MCA respectively.
Measured: Assessed in early labor (=< 4cm of cervical dilatation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start23 Dec 2022
- Primary completion30 Sep 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.
- Other trials for Ultrasonography, DopplerStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jute Richter, MD, PhD, Principal investigator, UZ Leuven / KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599178
- Sponsor's protocol ID
- S66995
- Status last verified
- Jun 2024
- First submitted
- 25 Oct 2022
- Last updated
- 1 Jul 2024
- 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 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doppler Findings in the Fetal Cerebral Blood Vessels (VA/MCA) Within 24 Hours Before Delivery and Relation With Perinatal Outcome.
- ClinicalTrials.gov ID
- NCT05599178
- Acronym / sponsor ID
- S66995
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 23 Dec 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 31 Oct 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.
- Assess differences in flow patterns in the fetal cerebral blood vessels within 24 hours before delivery between fetuses with a normal vs. adverse perinatal outcome.
- Explore maternal and/or fetal characteristics that might influence technical feasibility of doppler sonography of the fetal cerebral blood vessels in early labor at term.
- Assess reliability of the technique by measuring intra- and inter-observer variation in a subset of participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Term gestation | – | Other: Ultrasound examination in early labor |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- "Low-risk" pregnant women
Key inclusion criteria (10 listed)
- Singleton pregnancy.
- Term gestation (37-42 weeks).
- Fetus in cephalic presentation.
- No known fetal chromosomal or (severe) congenital anomaly.
- Normally grown fetus (ultrasound scan demonstrating normal fetal growth between 30-37 weeks of gestation, defined as an estimated fetal weight/abdominal circumference > 10th centile or crossing <2 quartiles compared to earlier growth ultrasound).
Key exclusion criteria (5 listed)
- Advanced labor (> 4cm of cervical dilatation) at the time of admission on the labor ward.
- Severe pre-existing chronic maternal medical condition or poor obstetric history/antenatal complications associated with increased risk of adverse perinatal outcome (non-exhaustive e.g.: uncontrolled chronic hypertension, severe pre-eclampsia, uncontrolled (gestational) diabetes, maternal sepsis, major antepartum haemorrhage, intra-uterine infection, prolonged rupture of membranes > 18 hours, etc.).
- Intra-uterine fetal demise / death.
- Prelabour rupture of membranes with meconium-stained amniotic fluid.
- Patients not fulfilling all the inclusion criteria or refusing to give written informed consent.
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 |
|---|---|---|
| Ultrasound examination in early laborCombined trans-abdominal and trans-perineal ultrasound examination | Other | Term gestation |
Primary outcome
Differences in VPR (Vertebro-Placental Ratio) between fetuses/neonates with a composite perinatal outcome score < 3 / => 3
Time frame: VPR measured in early labor (=< 4cm of cervical dilatation) - perinatal outcome score assessed at delivery - timespan between both observations variable, expected <12 hours.
2 secondary outcomes
Differences in other doppler parameters (PI VA, PI MCA, CPR) between fetuses/neonates with a composite perinatal outcome score < 3 / => 3.
Time frame: VPR measured in early labor (=< 4cm of cervical dilatation) - perinatal outcome score assessed at delivery - timespan between both observations variable, expected <12 hours.
Differences in maternal and fetal characteristics between successful and unsuccessful doppler examinations (observations) of the fetal VA and MCA respectively.
Time frame: Assessed in early labor (=< 4cm of cervical dilatation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- 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.
Jute Richter, MD, PhD principal investigator
UZ Leuven / KU Leuven
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 Ultrasonography, Doppler and Obstetric Labor Complications, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 10 inclusion and 5 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 1 Jul 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 Belgium. 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 Bram Packet (00321648824, bram.packet@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in VPR (Vertebro-Placental Ratio) between fetuses/neonates with a composite perinatal outcome score < 3 / => 3 (time frame: VPR measured in early labor (=< 4cm of cervical dilatation) - perinatal outcome score assessed at delivery - timespan between both observations variable, expected <12 hours.). 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 1 Jul 2024.