NCT01093144

Brief Summary

Assessing the relation between the Pelvis diameters measured by the LaborPro, and the mode of delivery(normal vaginal delivery/instrumental delivery/Caesarean section.

Trial Health

43
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 P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

March 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2010

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

March 25, 2010

Status Verified

March 1, 2010

Enrollment Period

Same day

First QC Date

March 24, 2010

Last Update Submit

March 24, 2010

Conditions

Keywords

Delivery modepelvic measurement

Outcome Measures

Primary Outcomes (1)

  • pelvis measurements influence on the Delivery mode

    pregnant woman's during a routine visit in the ultrasound unit will be requested to sign a concent and will undergo pelvic measurement using the LaborPro system. statistic analysis will ensue in order to ascertain the relationship between pelvic measurement and the mode of delivery.

    labor and delivery process

Secondary Outcomes (1)

  • the influence of maternal parameters on delivery mode.

    1 year

Interventions

pelvic measurements using the LaborPro Device,ultrasound non invasive measurements

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Singleton pregnancy
  • Pregnant adult woman in labor
  • Willing to participate in the study and understands the study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiba Medical Center

Tel Aviv, Israel

Location

Study Officials

  • Yinon Gilboa, Dr

    Tel Hashomer Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 24, 2010

First Posted

March 25, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

March 25, 2010

Record last verified: 2010-03

Locations