Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Middle Cerebral Artery Doppler in Uncomplicated Term Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02968017
Recruitment Status : Unknown
Verified November 2016 by Dr. Boaz.Weisz, Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : November 18, 2016
Last Update Posted : November 21, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Boaz.Weisz, Sheba Medical Center

Brief 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.


Condition or disease
Post Date

Detailed 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Variability in Middle Cerebral Artery Doppler Measurements in Uncomplicated Term Pregnancies.
Study Start Date : November 2016
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : March 2017

Group/Cohort
MCA-PI
Measurement Middle cerebral artery pulsatility index



Primary Outcome Measures :
  1. Pulsatility index (Doppler measurements) in the middle cerebral artery [ Time Frame: Full Term Pregnancies (37 to 42 weeks) ]
    Measurement MCA-PI Doppler



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Uncomplicated singleton pregnancies at 37-42 weeks.
Criteria

Inclusion Criteria:

Uncomplicated Term Pregnancies

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02968017


Contacts
Layout table for location contacts
Contact: Boaz Weisz, MD + 972 3 5302169 Boaz.Weisz@sheba.health.gov.il

Sponsors and Collaborators
Sheba Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Boaz Weisz, Prof Sheba Medical Center
Layout table for additonal information
Responsible Party: Dr. Boaz.Weisz, Professor of Fetal Medicine, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02968017    
Other Study ID Numbers: 3571-16-SMC
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Pregnancy, Prolonged
Pregnancy Complications