NCT02968017

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

November 21, 2016

Status Verified

November 1, 2016

Enrollment Period

Same day

First QC Date

November 13, 2016

Last Update Submit

November 18, 2016

Conditions

Post Date

Outcome Measures

Primary Outcomes (1)

  • Pulsatility index (Doppler measurements) in the middle cerebral artery

    Measurement MCA-PI Doppler

    Full Term Pregnancies (37 to 42 weeks)

Study Arms (1)

MCA-PI

Measurement Middle cerebral artery pulsatility index

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Uncomplicated singleton pregnancies at 37-42 weeks.

You may qualify if:

  • Uncomplicated Term Pregnancies

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pregnancy, Prolonged

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Boaz Weisz, Prof

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Boaz Weisz, MD

CONTACT

+ 972 3 5302169Boaz.Weisz@sheba.health.gov.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Fetal Medicine

Study Record Dates

First Submitted

November 13, 2016

First Posted

November 18, 2016

Study Start

November 1, 2016

Primary Completion

November 1, 2016

Study Completion

March 1, 2017

Last Updated

November 21, 2016

Record last verified: 2016-11