Middle Cerebral Artery Doppler in Uncomplicated Term Pregnancy

Post Date Clinical Trial

Official title:

Variability in Middle Cerebral Artery Doppler Measurements in Uncomplicated Term Pregnancies.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02968017
• Other study ID #: 3571-16-SMC
• Status: Not yet recruiting
• Phase: N/A
• First received: November 13, 2016
• Last updated: November 18, 2016
• Start date: November 2016
• Est. completion date: March 2017

Study information

• Verified date: November 2016
• Source: Sheba Medical Center
• Contact: Boaz Weisz, MD
• Phone: + 972 3 5302169
• Email: Boaz.Weisz[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

Uncomplicated Term Pregnancies

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Post Date

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulsatility index (Doppler measurements) in the middle cerebral artery	Measurement MCA-PI Doppler	Full Term Pregnancies (37 to 42 weeks)	No