Predicting Placental Pathologies by Ultrasound Imaging

Mayo Clinic

Status: Completed

Conditions: Villitis; IUGR; Intrauterine Growth Restriction

Treatments: Diagnostic Test: Comprehensive Doppler Ultrasound of the Placenta; Other: Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging)

Study type: Observational

Funder types: Other

Identifiers

NCT04506970

20-000991

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

60 participants in 2 patient groups

Intrauterine Growth Restriction

Description:

Pregnant women carrying a fetus identified with intrauterine growth restriction during the third trimester (\>28 weeks gestation)

Treatment:

Other: Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging)

Diagnostic Test: Comprehensive Doppler Ultrasound of the Placenta

Normal pregnancy

Description:

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.

Treatment:

Other: Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging)

Diagnostic Test: Comprehensive Doppler Ultrasound of the Placenta