Trial Outcomes & Findings for Predicting Placental Pathologies by Ultrasound Imaging (NCT NCT04506970)

NCT ID: NCT04506970

Last Updated: 2024-10-10

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 60 participants
• Primary outcome timeframe: Gestational age of 34-36 weeks
• Results posted on: 2024-10-10

Participant Flow

Enrollment from September 2020 through March 2023

Participant milestones

Measure	Intrauterine Growth Restriction Pregnant women carrying a fetus identified with intrauterine growth restriction during the third trimester (\>28 weeks gestation) Comprehensive Doppler Ultrasound of the Placenta: 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. Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging): 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.	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. Comprehensive Doppler Ultrasound of the Placenta: 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. Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging): 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.
Overall Study STARTED	40	20
Overall Study COMPLETED	40	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Predicting Placental Pathologies by Ultrasound Imaging

Baseline characteristics by cohort

Measure	Intrauterine Growth Restriction n=40 Participants Pregnant women carrying a fetus identified with intrauterine growth restriction during the third trimester (\>28 weeks gestation) Comprehensive Doppler Ultrasound of the Placenta: 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. Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging): 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.	Normal Pregnancy n=20 Participants 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. Comprehensive Doppler Ultrasound of the Placenta: 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. Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging): 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.	Total n=60 Participants Total of all reporting groups
Age, Continuous	31.7 years STANDARD_DEVIATION 5.2 • n=5 Participants	30.8 years STANDARD_DEVIATION 3.9 • n=7 Participants	31.4 years STANDARD_DEVIATION 4.8 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	20 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants	17 Participants n=7 Participants	55 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants	18 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	20 participants n=7 Participants	60 participants n=5 Participants
Gravidity	2.7 Pregnancies STANDARD_DEVIATION 1.58 • n=5 Participants	1.9 Pregnancies STANDARD_DEVIATION 1.33 • n=7 Participants	2.4 Pregnancies STANDARD_DEVIATION 1.53 • n=5 Participants
Maternal BMI at ultrasound	28.7 kg/m^2 STANDARD_DEVIATION 5.62 • n=5 Participants	28.3 kg/m^2 STANDARD_DEVIATION 4.2 • n=7 Participants	28.5 kg/m^2 STANDARD_DEVIATION 5.16 • n=5 Participants
Smoking	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Hypertension	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Preeclampsia	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Gestational Diabetes	8 Participants n=5 Participants	1 Participants n=7 Participants	9 Participants n=5 Participants
Hypothyroidism	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Gestational age of 34-36 weeks

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

Outcome measures

Measure	Intrauterine Growth Restriction n=40 Participants Pregnant women carrying a fetus identified with intrauterine growth restriction during the third trimester (\>28 weeks gestation) Comprehensive Doppler Ultrasound of the Placenta: 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. Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging): 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.	Normal Pregnancy n=20 Participants 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. Comprehensive Doppler Ultrasound of the Placenta: 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. Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging): 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.
Number of Participants With Uterine Artery Indices Completed	13 Participants	3 Participants

PRIMARY outcome

Timeframe: Gestational Age of 34-36 weeks

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

Outcome measures

Measure	Intrauterine Growth Restriction n=40 Participants Pregnant women carrying a fetus identified with intrauterine growth restriction during the third trimester (\>28 weeks gestation) Comprehensive Doppler Ultrasound of the Placenta: 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. Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging): 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.	Normal Pregnancy n=20 Participants 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. Comprehensive Doppler Ultrasound of the Placenta: 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. Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging): 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.
Number of Patients With Umbilical Artery Indices Completed	29 Participants	8 Participants

PRIMARY outcome

Timeframe: Gestational Age of 34-36 weeks

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)

Outcome measures

Measure	Intrauterine Growth Restriction n=34 Participants Pregnant women carrying a fetus identified with intrauterine growth restriction during the third trimester (\>28 weeks gestation) Comprehensive Doppler Ultrasound of the Placenta: 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. Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging): 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.	Normal Pregnancy n=11 Participants 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. Comprehensive Doppler Ultrasound of the Placenta: 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. Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging): 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.
Systolic(S)/Diastolic(D) Ratio	2.8 ratio Standard Deviation 0.7	2.3 ratio Standard Deviation 0.4

PRIMARY outcome

Timeframe: Gestational Age of 34-36 weeks

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

Outcome measures

Measure	Intrauterine Growth Restriction n=29 Participants Pregnant women carrying a fetus identified with intrauterine growth restriction during the third trimester (\>28 weeks gestation) Comprehensive Doppler Ultrasound of the Placenta: 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. Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging): 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.	Normal Pregnancy n=8 Participants 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. Comprehensive Doppler Ultrasound of the Placenta: 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. Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging): 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.
Resistance Index (RI)	0.6 Ratio Standard Deviation 0.7	0.6 Ratio Standard Deviation 0.08

PRIMARY outcome

Timeframe: Gestational age of 34-36 weeks

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

Outcome measures

Measure	Intrauterine Growth Restriction n=13 Participants Pregnant women carrying a fetus identified with intrauterine growth restriction during the third trimester (\>28 weeks gestation) Comprehensive Doppler Ultrasound of the Placenta: 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. Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging): 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.	Normal Pregnancy n=3 Participants 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. Comprehensive Doppler Ultrasound of the Placenta: 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. Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging): 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.
Pulsatility Index (PI)	1.0 Ratio Standard Deviation 0.2	0.7 Ratio Standard Deviation 0.0

PRIMARY outcome

Timeframe: Gestational age up to 42 weeks

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.

Outcome measures

Measure	Intrauterine Growth Restriction n=40 Participants Pregnant women carrying a fetus identified with intrauterine growth restriction during the third trimester (\>28 weeks gestation) Comprehensive Doppler Ultrasound of the Placenta: 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. Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging): 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.	Normal Pregnancy n=20 Participants 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. Comprehensive Doppler Ultrasound of the Placenta: 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. Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging): 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.
Number of Participants With Placental Pathology Indicating Chronic Villitis	8 Participants	7 Participants

SECONDARY outcome

Timeframe: Gestational age up to 42 weeks

The gestational age in weeks of when the baby was delivered.

Outcome measures

Measure	Intrauterine Growth Restriction n=40 Participants Pregnant women carrying a fetus identified with intrauterine growth restriction during the third trimester (\>28 weeks gestation) Comprehensive Doppler Ultrasound of the Placenta: 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. Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging): 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.	Normal Pregnancy n=20 Participants 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. Comprehensive Doppler Ultrasound of the Placenta: 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. Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging): 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.
Gestational Age at Birth	39.2 Weeks Standard Deviation 1.3	38.1 Weeks Standard Deviation 1.5

SECONDARY outcome

Timeframe: Gestational age up to 37 weeks

Pregnancy that delivered prior to 37 weeks gestational age

Outcome measures

Measure	Intrauterine Growth Restriction n=40 Participants Pregnant women carrying a fetus identified with intrauterine growth restriction during the third trimester (\>28 weeks gestation) Comprehensive Doppler Ultrasound of the Placenta: 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. Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging): 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.	Normal Pregnancy n=20 Participants 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. Comprehensive Doppler Ultrasound of the Placenta: 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. Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging): 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.
Preterm Labor	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Gestational age up to 42 weeks

Weight of infant at time of birth

Outcome measures

Measure	Intrauterine Growth Restriction n=40 Participants Pregnant women carrying a fetus identified with intrauterine growth restriction during the third trimester (\>28 weeks gestation) Comprehensive Doppler Ultrasound of the Placenta: 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. Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging): 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.	Normal Pregnancy n=20 Participants 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. Comprehensive Doppler Ultrasound of the Placenta: 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. Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging): 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.
Birth Weight of Infant	2598 Grams Standard Deviation 457	3348.5 Grams Standard Deviation 444

Adverse Events

Intrauterine Growth Restriction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Pregnancy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mauro Schenone

Mayo Clinic

Phone: 5072840210

Email: schenone.mauro@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place