Intrauterine Growth RestrictionNCT04506970
Predicting Placental Pathologies by Ultrasound Imaging
An observational study of Intrauterine Growth Restriction and Villitis, run by Mayo Clinic at 1 site in United States.
Trial summary
Intrauterine growth restriction (IUGR) is caused when the placenta cannot provide enough nutrients to allow normal growth of the fetus during pregnancy. It is unclear why IUGR happens, but an increase in inflammatory T cells in the placenta known as villitis of unknown etiology (VUE) is observed in many IUGR infants. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Intrauterine Growth Restriction, Villitis, IUGR
- What is being tested?
- Comprehensive Doppler Ultrasound of the Placenta and Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging)
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2020to 31 Oct 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Participants will be recruited from women obtaining prenatal care in the obstetrics clinic at Mayo Clinic in Rochester, Minnesota. This study will consist of two cohorts: 1) women diagnosed with intrauterine growth restriction (IUGR) and 2) women having uncomplicated pregnancies. Forty women will be enrolled after being diagnosed with IUGR. Based on prior clinical data it is expected that 50% will have a VUE diagnosis. Another cohort of 20 women having uncomplicated pregnancies will also be enrolled, matched for fetal sex and gestational age at ultrasound.
Who may be able to join
- Pregnancy > 28 weeks gestation
- Diagnosis of Intrauterine Growth Restriction (IUGR) before admission for labor and delivery
- Weight > 110 lbs (50 kg)
- Ability to understand and provide written informed consent
- Pregnancy > 28 weeks gestation
- No known pregnancy complications at prenatal obstetrical visit (+/- 1 week gestational age of matched subject in IUGR cohort)
- Weight > 110 lbs (50 kg)
- Ability to understand and provide written informed consent
Who cannot join
- Known immunodeficiency or pregnancy complication (i.e. preeclampsia or gestational diabetes)
- Known autoimmune disease (e.g., rheumatoid arthritis or systemic lupus erythematosus) or chronic hypertension
- Chronic, active viral infections, including HIV-1/2, HTLV-1/2, Hepatitis B or C
- Solid organ or transplant recipient
- Current smokers (tobacco exposure within 30 days of registration)
- Conceptions from assisted reproductive technology (prior Clomid use is allowed)
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- Multiple gestation
- Ruptured membranes
- Pregnancy <28 weeks gestation
- Not planning on delivering at Mayo Clinic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predicting Placental Pathologies by Ultrasound Imaging of the Human Placenta During Gestation
Intrauterine growth restriction (IUGR) is caused when the placenta cannot provide enough nutrients to allow normal growth of the fetus during pregnancy. It is unclear why IUGR happens, but an increase in inflammatory T cells in the placenta known as villitis of unknown etiology (VUE) is observed in many IUGR infants. The investigators aim to develop ultrasound methods for diagnosing VUE to understand it's role in IUGR.
Read the detailed description
Intrauterine growth restriction (IUGR) occurs in 3-10% of all pregnancies and is associated with significant morbidity and mortality during pregnancy, after birth and throughout the child's lifespan. IUGR is caused by the inability of the placental vasculature to provide enough oxygen and nutrients to support the fetus; yet, the mechanisms leading to disruption of placental vasculature are unknown. The placenta of ~50% of IUGR fetuses are infiltrated with inflammatory cells, specifically maternal T cells, which destroy placental blood vessels that support the fetus. This infiltration of T cells is known as villitis of unknown etiology (VUE). The diagnosis of VUE is problematic because it occurs without clinical signs and symptoms of maternal (or fetal) distress and puts the fetus at significant risk of demise. Additionally, VUE commonly recurs in subsequent pregnancies putting future offspring at risk. Yet, the exact prevalence of VUE and its significance in IUGR pathogenesis and outcomes are poorly understood as VUE is only diagnosed after the infant is outside the womb. Therefore, the study aims to recognize risk factors and cellular mechanisms associated with VUE and develop methods for diagnosing and treating VUE in utero, in order to improve infant health.
- Conditions
- Intrauterine Growth Restriction, Villitis, IUGR
- Being tested
- Comprehensive Doppler Ultrasound of the Placenta, Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging)
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Doppler Ultrasound of the PlacentaDiagnostic test
Ultrasound measures to be collected include uterine artery (UtA) and umbilical artery (UA), systolic/diastolic (S/D) ratio, resistance index (RI), pulsatility index (PI) and presence of early diastolic notch.
Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging)Other
In addition, a Verasonics ultrasound scanner will be used for ultra-sensitive Doppler imaging. Data will be collected on vessel density, periphery-to-center vessel density ratio (VDR) and microvessel morphology.
| Study group | Role | What they receive |
|---|---|---|
| Intrauterine Growth Restriction | Pregnant women carrying a fetus identified with intrauterine growth restriction during the third trimester (>28 weeks gestation) Receives: Diagnostic Test: Comprehensive Doppler Ultrasound of the Placenta; Other: Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging) | |
| Normal pregnancy | Pregnant women identified with an uncomplicated pregnancy during the third trimester (>28 weeks), matched for fetal sex and gestational age with women enrolled in the IUGR group. Receives: Diagnostic Test: Comprehensive Doppler Ultrasound of the Placenta; Other: Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Uterine Artery Indices Completed
Measured by Doppler and 3D microvessel imaging, used to calculate outcomes 3-5
Measured: Gestational age of 34-36 weeks
Number of Patients With Umbilical Artery Indices Completed
Measured by Doppler and 3D microvessel imaging, used to calculate outcomes 3-5
Measured: Gestational Age of 34-36 weeks
Systolic(S)/Diastolic(D) Ratio
S = Systolic peak (max velocity); Maximum velocity during contraction of the fetal heart.
D = End-diastolic flow; Continuing forward flow in the umbilical artery during the relaxation phase of the heartbeat.
S/D ratio = (systolic / diastolic ratio)
Measured: Gestational Age of 34-36 weeks
Resistance Index (RI)
Resistance index (RI) = (systolic velocity - diastolic velocity / systolic velocity)
Measured: Gestational Age of 34-36 weeks
Pulsatility Index (PI)
Pulsatility index (PI) = (systolic velocity - diastolic velocity / mean velocity)
Measured: Gestational age of 34-36 weeks
Number of Participants With Placental Pathology Indicating Chronic Villitis
Using the Amsterdam criteria, following delivery, placentae will be histologically examined for placental villitis (presence of maternal T cells) and graded by severity. High grade involves greater than 10 villi while low grade affects fewer than 10 villi.
Measured: Gestational age up to 42 weeks
Secondary outcomes (3)
Gestational Age at Birth
The gestational age in weeks of when the baby was delivered.
Measured: Gestational age up to 42 weeks
Preterm Labor
Pregnancy that delivered prior to 37 weeks gestational age
Measured: Gestational age up to 37 weeks
Birth Weight of Infant
Weight of infant at time of birth
Measured: Gestational age up to 42 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start27 Sep 2020
- Primary completion31 Jul 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intrauterine Growth RestrictionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro H. Schenone, Mayo Clinic
- Investigators
- Mauro Schenone, MD, Principal investigator, Mayo ClinicElizabeth Ann L Enninga, PhD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506970
- Sponsor's protocol ID
- 20-000991
- Status last verified
- Jul 2024
- First submitted
- 23 Jul 2020
- Last updated
- 10 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Placental Pathologies by Ultrasound Imaging of the Human Placenta During Gestation
- ClinicalTrials.gov ID
- NCT04506970
- Acronym / sponsor ID
- 20-000991
- Conditions
- Intrauterine Growth Restriction, Villitis, IUGR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 27 Sep 2020 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 10 Aug 2020 (actual)
- Results
- Posted 10 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intrauterine growth restriction (IUGR) is caused when the placenta cannot provide enough nutrients to allow normal growth of the fetus during pregnancy. It is unclear why IUGR happens, but an increase in inflammatory T cells in the placenta known as villitis of unknown etiology (VUE) is observed in many IUGR infants. The investigators aim to develop ultrasound methods for diagnosing VUE to understand it's role in IUGR.
Detailed description
Intrauterine growth restriction (IUGR) occurs in 3-10% of all pregnancies and is associated with significant morbidity and mortality during pregnancy, after birth and throughout the child's lifespan. IUGR is caused by the inability of the placental vasculature to provide enough oxygen and nutrients to support the fetus; yet, the mechanisms leading to disruption of placental vasculature are unknown. The placenta of ~50% of IUGR fetuses are infiltrated with inflammatory cells, specifically maternal T cells, which destroy placental blood vessels that support the fetus. This infiltration of T cells is known as villitis of unknown etiology (VUE). The diagnosis of VUE is problematic because it occurs without clinical signs and symptoms of maternal (or fetal) distress and puts the fetus at significant risk of demise. Additionally, VUE commonly recurs in subsequent pregnancies putting future offspring at risk. Yet, the exact prevalence of VUE and its significance in IUGR pathogenesis and outcomes are poorly understood as VUE is only diagnosed after the infant is outside the womb. Therefore, the study aims to recognize risk factors and cellular mechanisms associated with VUE and develop methods for diagnosing and treating VUE in utero, in order to improve infant health.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrauterine Growth Restriction | – | Diagnostic Test: Comprehensive Doppler Ultrasound of the Placenta, Other: Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging)Pregnant women carrying a fetus identified with intrauterine growth restriction during the third trimester (>28 weeks gestation) |
| Normal pregnancy | – | Diagnostic Test: Comprehensive Doppler Ultrasound of the Placenta, Other: Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging)Pregnant women identified with an uncomplicated pregnancy during the third trimester (>28 weeks), matched for fetal sex and gestational age with women enrolled in the IUGR group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants will be recruited from women obtaining prenatal care in the obstetrics clinic at Mayo Clinic in Rochester, Minnesota. This study will consist of two cohorts: 1) women diagnosed with intrauterine growth restriction (IUGR) and 2) women having uncomplicated pregnancies. Forty women will be enrolled after being diagnosed with IUGR. Based on prior clinical data it is expected that 50% will have a VUE diagnosis. Another cohort of 20 women having uncomplicated pregnancies will also be enrolled, matched for fetal sex and gestational age at ultrasound.
Key inclusion criteria (8 listed)
- Pregnancy > 28 weeks gestation
- Diagnosis of Intrauterine Growth Restriction (IUGR) before admission for labor and delivery
- Weight > 110 lbs (50 kg)
- Ability to understand and provide written informed consent
- Pregnancy > 28 weeks gestation
Key exclusion criteria (10 listed)
- Known immunodeficiency or pregnancy complication (i.e. preeclampsia or gestational diabetes)
- Known autoimmune disease (e.g., rheumatoid arthritis or systemic lupus erythematosus) or chronic hypertension
- Chronic, active viral infections, including HIV-1/2, HTLV-1/2, Hepatitis B or C
- Solid organ or transplant recipient
- Current smokers (tobacco exposure within 30 days of registration)
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 |
|---|---|---|
| Comprehensive Doppler Ultrasound of the PlacentaUltrasound measures to be collected include uterine artery (UtA) and umbilical artery (UA), systolic/diastolic (S/D) ratio, resistance index (RI), pulsatility index (PI) and presence of early diastolic notch. | Diagnostic test | Intrauterine Growth Restriction, Normal pregnancy |
| Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging)In addition, a Verasonics ultrasound scanner will be used for ultra-sensitive Doppler imaging. Data will be collected on vessel density, periphery-to-center vessel density ratio (VDR) and microvessel morphology. | Other | Intrauterine Growth Restriction, Normal pregnancy |
Primary outcome
Number of Participants With Uterine Artery Indices Completed
Time frame: Gestational age of 34-36 weeks
Measured by Doppler and 3D microvessel imaging, used to calculate outcomes 3-5
Number of Patients With Umbilical Artery Indices Completed
Time frame: Gestational Age of 34-36 weeks
Measured by Doppler and 3D microvessel imaging, used to calculate outcomes 3-5
Systolic(S)/Diastolic(D) Ratio
Time frame: Gestational Age of 34-36 weeks
S = Systolic peak (max velocity); Maximum velocity during contraction of the fetal heart. D = End-diastolic flow; Continuing forward flow in the umbilical artery during the relaxation phase of the heartbeat. S/D ratio = (systolic / diastolic ratio)
Resistance Index (RI)
Time frame: Gestational Age of 34-36 weeks
Resistance index (RI) = (systolic velocity - diastolic velocity / systolic velocity)
Pulsatility Index (PI)
Time frame: Gestational age of 34-36 weeks
Pulsatility index (PI) = (systolic velocity - diastolic velocity / mean velocity)
Number of Participants With Placental Pathology Indicating Chronic Villitis
Time frame: Gestational age up to 42 weeks
Using the Amsterdam criteria, following delivery, placentae will be histologically examined for placental villitis (presence of maternal T cells) and graded by severity. High grade involves greater than 10 villi while low grade affects fewer than 10 villi.
3 secondary outcomes
Gestational Age at Birth
Time frame: Gestational age up to 42 weeks
Preterm Labor
Time frame: Gestational age up to 37 weeks
Birth Weight of Infant
Time frame: Gestational age up to 42 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Mauro Schenone, MD principal investigator
Mayo Clinic
Elizabeth Ann L Enninga, PhD study chair
Mayo Clinic
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 Intrauterine Growth Restriction and Villitis, run by Mayo Clinic at 1 site in United States.
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 10 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 10 Oct 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 United States. 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?
Yes. Results are posted in the registry (first posted 10 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Uterine Artery Indices Completed (time frame: Gestational age of 34-36 weeks). 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 10 Oct 2024.