NCT01816737

Brief Summary

Two earlier studies showed measurable fetal hemodynamics changes caused by external pressure induced by te abdominal ultrasound transducer. The investigators would like to study the response of flow in main fetal vessels to different, mild to moderate pressures induced by the abdominal transducer. The pressure induced by the transducer will be measured by a digital computed manometer. The flow chances in fetal vessels will be measured by ultrasound Doppler. Measurements will be taken on different pregnancy weeks, on one occasion in each pregnant woman. Ones without applying transducer pressure (control) and ones after applying mild pressure.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Last Updated

March 22, 2013

Status Verified

March 1, 2013

Enrollment Period

7 months

First QC Date

March 20, 2013

Last Update Submit

March 21, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • pulsatility index in fetal vessels

    at the time of pressure aplication

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

pregnant women

You may qualify if:

  • singleton

You may not qualify if:

  • multiple gestation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2013

First Posted

March 22, 2013

Study Start

March 1, 2013

Primary Completion

October 1, 2013

Last Updated

March 22, 2013

Record last verified: 2013-03