Does the Cerebroplacental Ratio (CPR) Predict Adverse Outcomes in Low Risk Pregnancies?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

580 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-15

Study Completion Date

2020-05-07

Brief Summary

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Ultrasound Doppler studies are used during pregnancy to help manage pregnancies complicated by fetal growth restriction. The cerebroplacental ratio may predict adverse outcomes in low risk pregnancies. In a prospective study, the investigators will examine whether fetuses with an abnormal CPR at or near term are at increased risk for being delivered by cesarean,

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Detailed Description

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This is a multicenter prospective study of low-risk nulliparous women who will be recruited if they are having an ultrasound at 36 weeks of estimated gestational age or greater. As part of the study, women will have umbilical and middle cerebral artery Doppler studies and the CPR will be calculated by dividing the middle cerebral artery PI by the umbilical artery PI. Providers caring for study subjects will be blinded to this result. Pregnancy outcomes in women with CPR values less than the 10th percentile for gestational age will be compared to those with CPR values above the 10th percentile.

A secondary aim of the study is to analyze CPR as a continuous variable.

Conditions

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Cerebroplacental Ratio

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CPR less than the 10%le

Group of patients with fetuses with cerebroplacental ratio less than 10%le

No interventions assigned to this group

CPR greater or equal than 10%le

Group of patients with fetuses with cerebroplacental ratio greater or equal than 10%le

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Nulliparous pregnant women between the ages of 18 and 45 years with low risk pregnancies who present for obstetrical ultrasound at 36 weeks of gestation or later with a planned delivery at a Perinatal Research Consortium hospital.

Exclusion Criteria

* Multifetal pregnancy at the time of presentation
* Known fetal chromosomal anomaly
* Known fetal malformation
* Preeclampsia
* Fetal growth restriction
* Multiparity
* Prior cesarean section
* Placental abnormalities such as previa or accreta
* Pregestational diabetes
* Plan to deliver outside the Perinatal Research Consortium affiliated hospitals

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes