Middle Cerebral Artery Doppler in Uncomplicated Term Pregnancy

NCT ID: NCT02968017

Last Updated: 2016-11-21

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

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-03-31

Brief Summary

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Doppler measurements in the Middle Cerebral Artery (MCA) is a part of the assessment for assessing fetal well-being in complicated pregnancy, including Intra Uterine Growth Retardation and Fetal Anemia.

The use of this Doppler measurement in uncomplicated term pregnancies is not a common practice due to lack of information. However, several studies use the MCA Pulsatility Index (PI) as part of the Cerebro-Placental-Ratio (CPR) measurment at term.

The purpose of this trial is to assess MCA Doppler variability in term, uncomplicated pregnancy.

Detailed Description

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Measuring the resistance in the fetal middle cerebral artery (MCA) is an important factor in assessing fetal well-being. On its own, the Pulsatility Index (PI) in the MCA may indicate a decrease in fetal oxygenation. Furthermore, the PI measured in the Fetal MCA is an index parameter in the calculation of the Cerebro-Placental Ratio (CPR) used to evaluate whether there is an existing disturbance in the Placental-Umbilical and Feto-cerebral circulations. The CPR is a measurement that enables practitioners to predict the fetuses reaction to intrauterine hypoxemia. The CPR measurement is commonly used to evaluate small for gestational age (SGA) fetuses and to distinguish between constitutionally small fetuses and ones that suffer from placental insufficiency. For those who suffer from placental insufficiency, the CPR measurement is an aid in deciding the optimal time and mode of delivery.

Recently, researchers pondered if the CPR measurement may aid in predicting disturbance in fetal oxygenation during delivery. A number of studies have showed that appropriate for gestational age fetuses with abnormal CPR measurements may be susceptible to delivery complications in the same manner as fetuses who suffer from placental insufficiency. The question that is yet to be answered is whether the MCA measurement reliable in term pregnancies. This question arises due to the impression that the MCA measurement at term is highly variable, even when taken under optimal conditions.

The aim of this study is to evaluate the intra-observer variability in the MCA measurement under optimal conditions, in Uncomplicated Term Pregnancies.

Conditions

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Post Date

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MCA-PI

Measurement Middle cerebral artery pulsatility index

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Uncomplicated Term Pregnancies

Exclusion Criteria

High Risk Pregnancies including placental insufficiency, intrauterine growth retardation or any maternal vascular disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Boaz.Weisz

Professor of Fetal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Boaz Weisz, Prof

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Central Contacts

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Boaz Weisz, MD

Role: CONTACT

Phone: + 972 3 5302169

Email: [email protected]

Other Identifiers

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3571-16-SMC

Identifier Type: -

Identifier Source: org_study_id