Predicting Placental Pathologies by Ultrasound Imaging

NCT04506970 | Completed Results

• 1 other identifier: 20-000991
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Villitis; IUGR; Intrauterine Growth Restriction

Outcome Measures

Primary Outcomes (6)

• Number of Participants With Uterine Artery Indices Completed

  Measured by Doppler and 3D microvessel imaging, used to calculate outcomes 3-5

  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

  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)

  Gestational Age of 34-36 weeks

• Resistance Index (RI)

  Resistance index (RI) = (systolic velocity - diastolic velocity / systolic velocity)

  Gestational Age of 34-36 weeks

• Pulsatility Index (PI)

  Pulsatility index (PI) = (systolic velocity - diastolic velocity / mean velocity)

  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.

  Gestational age up to 42 weeks

Secondary Outcomes (3)

• Gestational Age at Birth

  Gestational age up to 42 weeks

• Preterm Labor

  Gestational age up to 37 weeks

• Birth Weight of Infant

  Gestational age up to 42 weeks

Study Arms (2)

Intrauterine Growth Restriction

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

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.

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

Interventions

Comprehensive Doppler Ultrasound of the Placenta DIAGNOSTIC_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.

Intrauterine Growth Restriction; Normal pregnancy

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.

Intrauterine Growth Restriction; Normal pregnancy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mauro Schenone
• Organization: Mayo Clinic

schenone.mauro@mayo.edu

5072840210

Study Officials

• Mauro Schenone, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Elizabeth Ann L Enninga, PhD

  Mayo Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: August 10, 2020
• Study Start: September 27, 2020
• Primary Completion: July 31, 2023
• Study Completion: October 31, 2023
• Last Updated: October 10, 2024
• Results First Posted: October 10, 2024

Record last verified: 2024-07

Locations

US (1)