Clinical trial NCT04506970: Predicting Placental Pathologies by Ultrasound Imaging
Official title: Predicting Placental Pathologies by Ultrasound Imaging of the Human Placenta During Gestation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intrauterine Growth Restriction
Villitis
IUGR
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Uterine Artery Indices Completed
timeFrame: Gestational age of 34-36 weeks
measure: Number of Patients With Umbilical Artery Indices Completed
timeFrame: Gestational Age of 34-36 weeks
measure: Systolic(S)/Diastolic(D) Ratio
timeFrame: Gestational Age of 34-36 weeks
measure: Resistance Index (RI)
timeFrame: Gestational Age of 34-36 weeks
measure: Pulsatility Index (PI)
timeFrame: Gestational age of 34-36 weeks
measure: Number of Participants With Placental Pathology Indicating Chronic Villitis
timeFrame: Gestational age up to 42 weeks
Secondary outcomes:
measure: Gestational Age at Birth
timeFrame: Gestational age up to 42 weeks
measure: Preterm Labor
timeFrame: Gestational age up to 37 weeks
measure: Birth Weight of Infant
timeFrame: Gestational age up to 42 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mauro Schenone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Elizabeth Ann L Enninga, PhD
role: STUDY_CHAIR
References: