Prenatal Sonographic Prediction of Placental Histology and Function

Pregnancy Complications Clinical Trial

Official title:

Prenatal Sonographic Prediction of Placental Histology and Function

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06022458
• Other study ID #: EH23-068
• Status: Active, not recruiting
• Start date: May 28, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: May 2024
• Source: NorthShore University HealthSystem
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this two-phase observational study is to investigate the use of ultrasonography to predict placental pathology at the time of delivery.

Description:

Placenta pathology is examined at the time of delivery and can show the underlying pathophysiology of adverse pregnancy outcomes. The Amsterdam consensus has identified four primary categories of injury, acute inflammation, fetal vascular malperfusion, maternal vascular malperfusion, and chronic inflammation associated with adverse obstetric outcomes. Findings from placental pathologic examination performed at delivery can reveal important patterns of injury that lead to adverse pregnancy outcomes but cannot aid in preventing these outcomes. Ultrasound of the placenta may be able to detect placental pathology in the antepartum period to potentially aid in detection and treatment of placental injury. One specific scenario it may be useful in is in the setting of fetal growth restriction, which can be constitutional or pathologic. Identification of growth restriction in the setting of placental injury may identify those patients at greatest risk for adverse outcomes.

In the retrospective portion of this study, researchers will retrospectively evaluate archived ultrasonographic images during pregnancies affected by stillbirth, severe placental histology, fetal growth restriction, and milder histologic abnormalities. The goal of this phase is to develop image processing of placentas and to utilize the image processing of existing sonograms to correlate with the presence or absence of placental pathology at the time of delivery.

The prospective portion of this study the researchers will utilize image processing techniques from the initial phase to prospectively assess placental function. The goal of this phase is to evaluate if placental size, vasculature, and echogenicities among fetuses with suspected growth restriction are associated with maternal vascular mal perfusion on placental pathology. Twenty patients with fetal growth restriction by estimated fetal weight (EFW) < 10th percentile or fetal abdominal circumference (AC) < 10th percentile and EFW < 20th percentile will be recruited as the exposure group. Participants who consent will complete sonographic measurements of the placenta, predefined image capture of color flow to the placenta, and grayscale images every two weeks. Another twenty patients without SGA (small for gestational age) or significant comorbidities will be recruited in the unexposed control group. Upon consenting, these participants will complete sonographic measurements of the placenta for one time. For both groups, information will be abstracted from electronic medical records regarding demographic data, neonatal outcomes, and placental histology. Imaging characteristics will be compared by placental histology and grade of histology at delivery. As this is a pilot project, there is not an a priori power analysis.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 320
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Retrospective Phase

Inclusion criteria:

• Patients with delivery in NorthShore University HealthSystem,

• Ultrasound available within 4 weeks of delivery with adequate placental images

• Placental pathology available

Exclusion criteria:

• Multiple gestation

Prospective Phase Inclusion criteria

• Exposed: Patients with singleton gestation with fetal growth restriction at 20-28 weeks with a plan to deliver at NorthShore Highland Park Hospital Evanston Hospital. Patients must have a first-trimester ultrasound (<14 weeks) to confirm pregnancy dating available in the electronic medical record.

• Unexposed: Patients who present for routine ultrasound evaluation at 36-38 weeks with normal fetal growth with a plan to deliver at NorthShore Highland Park Hospital or NorthShore Evanston Hospital.

Exclusion criteria:

• Exposed: Multiple gestation, major fetal anomaly

• Unexposed: Multiple gestation, history of chronic hypertension, gestational or pregestational diabetes, major fetal anomaly antiphospholipid syndrome, known thrombophilia

Related Conditions & MeSH terms

• Pregnancy Complications

Locations

Country	Name	City	State
United States	NorthShore University HealthSystem	Evanston	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
NorthShore University HealthSystem

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Imaging characteristics	Imaging characteristics will be compared by those with and without placental pathology found at the time of delivery	Image characteristics will be collected every 2 weeks prenatally, and placenta will be collected at the time of delivery for analysis, this will be up to 22 weeks