Post DateNCT02968017
Middle Cerebral Artery Doppler in Uncomplicated Term Pregnancy
An observational study of Post Date, run by Sheba Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Date
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Uncomplicated singleton pregnancies at 37-42 weeks.
Who may be able to join
- Uncomplicated Term Pregnancies
Who cannot join
- High Risk Pregnancies including placental insufficiency, intrauterine growth retardation or any maternal vascular disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Variability in Middle Cerebral Artery Doppler Measurements in Uncomplicated Term Pregnancies.
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.
Read the 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.
- Conditions
- Post Date
- Medical subject headings
- Pregnancy, Prolonged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MCA-PI | Measurement Middle cerebral artery pulsatility index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulsatility index (Doppler measurements) in the middle cerebral artery
Measurement MCA-PI Doppler
Measured: Full Term Pregnancies (37 to 42 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post DateStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Boaz.Weisz, Sheba Medical Center
- Investigators
- Boaz Weisz, Prof, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968017
- Sponsor's protocol ID
- 3571-16-SMC
- Status last verified
- Nov 2016
- First submitted
- 13 Nov 2016
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variability in Middle Cerebral Artery Doppler Measurements in Uncomplicated Term Pregnancies.
- ClinicalTrials.gov ID
- NCT02968017
- Acronym / sponsor ID
- 3571-16-SMC
- Conditions
- Post Date
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Nov 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 18 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MCA-PI | – | –Measurement Middle cerebral artery pulsatility index |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Uncomplicated singleton pregnancies at 37-42 weeks.
Key inclusion criteria (1 listed)
- Uncomplicated Term Pregnancies
Key exclusion criteria (1 listed)
- High Risk Pregnancies including placental insufficiency, intrauterine growth retardation or any maternal vascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pulsatility index (Doppler measurements) in the middle cerebral artery
Time frame: Full Term Pregnancies (37 to 42 weeks)
Measurement MCA-PI Doppler
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boaz Weisz, Prof principal investigator
Sheba Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Post Date, run by Sheba Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Boaz Weisz, MD (+ 972 3 5302169, Boaz.Weisz@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulsatility index (Doppler measurements) in the middle cerebral artery (time frame: Full Term Pregnancies (37 to 42 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2016.