NCT00827125

Brief Summary

The purpose of this study is to establish normograms of parameters measured by the LaborPro system. To test the prediction of these parameters on labor progress and mode of delivery.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
650

participants targeted

Target at P75+ for phase_2 pregnancy

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_2 pregnancy

Geographic Reach
2 countries

2 active sites

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

January 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 22, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

January 5, 2010

Status Verified

January 1, 2009

Enrollment Period

11 months

First QC Date

January 21, 2009

Last Update Submit

January 4, 2010

Conditions

PregnancyLabor

Keywords

active stagelaborprogressionpregnant woman during active phases of labor

Outcome Measures

Primary Outcomes (1)

  • Assessment of the LaborPro as a prediction tool of labor progression. by introducing extended labor curves.

    1 year

Secondary Outcomes (1)

  • Assessing the influence of obstetric and maternal parameters on the labor progression,relation between the pelvis diameters and Pubic Arch Angle measured by the LaborPro, and labor progression and mode of delivery,Maternal Satisfaction.

    1 year

Interventions

LaborPro deviceDEVICE

monitoring labor progression by using a new device The LaborPro system (Trig Medical Inc) allows determination of fetal head station and position using ultrasound and position tracking system.

Also known as: LaborPro TrigMedical

Eligibility Criteria

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

You may qualify if:

  • Singleton pregnancy
  • Pregnant adult woman in labor
  • Gestational age 37-42 wks
  • Vertex presentation
  • Willing to participate in the study and understands the study

You may not qualify if:

  • Fetal malformations
  • Fetal distress

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Maimonides Medical Center

New York, New York, United States

COMPLETED

bnai-Zion Medical center

Haifa, Israel

RECRUITING

Related Publications (1)

  • Haberman S, Atallah F, Nizard J, Buhule O, Albert P, Gonen R, Ville Y, Paltieli Y. A Novel Partogram for Stages 1 and 2 of Labor Based on Fetal Head Station Measured by Ultrasound: A Prospective Multicenter Cohort Study. Am J Perinatol. 2021 Aug;38(S 01):e14-e20. doi: 10.1055/s-0040-1702989. Epub 2020 Mar 2.

    PMID: 32120420DERIVED

MeSH Terms

Conditions

Disease Progression

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Tzipi Yakoby, Director of Clinical Marketing

CONTACT

+972-4-9597930tzipi@TrigMed.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 21, 2009

First Posted

January 22, 2009

Study Start

March 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

January 5, 2010

Record last verified: 2009-01

Locations

US(1)IL(1)