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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04506970
Other study ID # 20-000991
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 27, 2020
Est. completion date October 31, 2023

Study information

Verified date November 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. The investigators aim to develop ultrasound methods for diagnosing VUE to understand it's role in IUGR.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 31, 2023
Est. primary completion date July 31, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria for IUGR study cohort: - 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 Inclusion Criteria for control cohort: - 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 Exclusion Criteria: - 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) - Multiple gestation - Ruptured membranes - Pregnancy <28 weeks gestation - Not planning on delivering at Mayo Clinic

Study Design


Intervention

Diagnostic Test:
Comprehensive Doppler Ultrasound of the Placenta
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.
Other:
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.

Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Uterine artery indices Measured by Doppler and 3D microvessel imaging, used to calculate outcomes 3-5 34-36 weeks
Primary Umbilical artery indices Measured by Doppler and 3D microvessel imaging, used to calculate outcomes 3-5 34-36 weeks
Primary 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)
34-36 weeks
Primary Resistance index (RI) Resistance index (RI) = (systolic velocity - diastolic velocity / systolic velocity) 34-36 weeks
Primary Pulsatility index (PI) Pulsatility index (PI) = (systolic velocity - diastolic velocity / mean velocity) 34-36 weeks
Primary Placental pathology 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. up to 42 weeks
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