Middle Cerebral Artery Doppler in Uncomplicated Term Pregnancy
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|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
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|
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|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|
Measurement Middle cerebral artery pulsatility index
- Pulsatility index (Doppler measurements) in the middle cerebral artery [ Time Frame: Full Term Pregnancies (37 to 42 weeks) ]Measurement MCA-PI Doppler
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
|Contact: Boaz Weisz, MD||+ 972 3 5302169||Boaz.Weisz@sheba.health.gov.il|
|Principal Investigator:||Boaz Weisz, Prof||Sheba Medical Center|