Placenta Imaging Project

Completed

• Conditions: High Risk Pregnancy
• Interventions: Device: MRI; Device: MRI - IUGR

• Registration Number: NCT02749851
• Lead Sponsor: Oregon Health and Science University

Brief Summary

The purpose of this study is to test the application of newly generated magnetic resonance imaging (MRI) protocols for the assessment of placental perfusion in human subjects. The primary objective is to validate and establish the utility of placental MRI in pregnant women. The study will be entirely MRI-technology based with collection of placental tissue at the time of infant delivery for later correlative studies.

Detailed Description

The placenta provides all the nutrition from a pregnant mother to a developing fetus. A placenta that functions normally is needed to ensure normal fetal growth and development. Unfortunately, the placenta is the least understood human organ even though it is involved in all pregnancy complications. The placenta is so poorly understood because our current methods to look at it during pregnancy, like ultrasound, do not provide enough information about placental growth and function.

This study will help provide information about:

* How the placenta grows and develops during pregnancy

* How the placenta delivers nutrients, like oxygen to the developing fetus

* If placental function using new advanced imaging tools can predict pregnancy complications like fetal growth restriction, stillbirth, preeclampsia and preterm labor

This study will explore how blood flow to the placenta affects placental growth, fetal growth, and oxygen delivery to the fetus. Blood flow to the placenta may determine how the placenta supports fetal growth and development. Having a way to measure placental function during pregnancy may provide a way to understand normal pregnancies but importantly also identify pregnancies at increased risk for pregnancy complications.

Additionally we want to have an ancillary intrauterine growth restriction (IUGR) arm; the objective of this ancillary study is to test the sensitivity of the placental MRI protocol in women with confirmed cases of IUGR in the third trimester.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2016-02-08
• Study First Submitted QC: 2016-04-22
• Study First Posted: 2016-04-25
• Study Start: 2016-10-13
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-01
• Last Update Posted: 2020-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 379

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Smokers	MRI	Pregnant women that identify as smokers will receive the MRI Imaging intervention.
High risk/Non-Smokers	MRI	Pregnant women that identify as non-smokers who are at a high risk for adverse outcomes based on prior clinical history will receive the MRI Imaging intervention.
Confirmed IUGR	MRI - IUGR	Pregnant women identified by their clinical care provided to have confirmed IUGR during their current pregnancy
Non-smokers	MRI	Pregnant women that identify as non-smokers with low risk for placental insufficiency will receive the MRI Imaging intervention.

Primary Outcome Measures

Name	Time	Method
Composite of placenta-mediated adverse pregnancy outcomes	39 weeks gestation	A binary variable indication whether the placenta-mediated adverse pregnancy has observed within 39 weeks gestation; Composite of placenta-mediated adverse pregnancy outcomes defined as the presence of at least one of the following: 1. Fetal death (not due to genetic or infectious etiology),; 2. Preeclampsia or gestational hypertension,; 3. Small for gestational age fetus \< 5%,; 4. Oligohydramnios (defined as amniotic fluid index (AFI) \< 5 cm) prompting delivery prior to 39 weeks gestation,; 5. Abnormal fetal heart rate tracing prompting delivery prior to 39 weeks gestation,; 6. Abnormal umbilical artery Doppler velocimetry prompting delivery prior to 39 weeks gestation.
Optimal cutoff values of placental MRI for placenta mediated adverse outcomes using receiver operating characteristics (ROC)	Change from 16, 24, and 32 weeks gestation	Determine the sensitivity and specificity of placental MRI at 16, 24, and 32 weeks gestation for identifying risk of adverse clinical outcome identified later in pregnancy. Optimal cutoff values of placental MRI for placenta mediated adverse outcomes using receiver operating characteristics (ROC).
Placental perfusion (Units of measure: ml/min) measured at 3 time points across gestation.	Change from 16, 24, and 32 weeks gestation	This will allow perfusion changes across pregnancy to be quantified in women from the three study groups.

Secondary Outcome Measures

Name	Time	Method
Composite of Placenta histologic outcomes	39 weeks gestation	Composite of placental histologic outcomes defined as the presence of one of the following: 1. accelerated villous maturation; 2. abnormal villous cytotrophoblast proliferation; 3. microscopic infarctions; 4. decidual vasculopathy
Small for gestational age fetus at 3% and 5%	39 weeks gestation
Gestational age at delivery prior to 37 weeks gestation.	37 weeks gestation
Diagnosis of preeclampsia using standard clinical criteria	39 weeks gestation

Trial Locations

Locations (2)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States