NCT01360905

Brief Summary

The purpose of this study is to compare the Monica AN24 fetal monitor to previously FDA approved devices for Fetal Heart Rate and Uterine Contractions in labor for Multiples and pre term labor.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

May 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 26, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 20, 2014

Status Verified

January 1, 2014

Enrollment Period

1.2 years

First QC Date

May 24, 2011

Last Update Submit

January 17, 2014

Conditions

Pre Term LaborMultiple Pregnancy

Keywords

PTLMultiples

Outcome Measures

Primary Outcomes (1)

  • equivalence with predicate device

    12 months

Eligibility Criteria

Age17 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population is women of \>= 24 weeks of singleton pregnancy or women of \>=24 weeks of multiple pregnancy, that have been admitted to the Labor and delivery suite

You may qualify if:

  • She is \>=24weeks 0days but less than 36 completed weeks, with a singleton pregnancy or \>=34weeks 0days with a multiple pregnancy and has been admitted to the Labor and Delivery Unit
  • She is in the latent phase of spontaneous labor, or has been admitted for induction of labor
  • She has given her informed consent to participate as a subject

You may not qualify if:

  • Known major fetal malformation or chromosome abnormality
  • Involvement in another clinical trial currently or previously in this pregnancy
  • Medical or obstetric problem that would preclude the use of abdominal electrodes (e.g., skin eruptions, sensitivity to adhesives)
  • Significant medical or obstetric problem that in the investigator's opinion would make the woman incapable of taking part in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Study Officials

  • Fadi Mizra, Dr

    New York Presbytarian Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2011

First Posted

May 26, 2011

Study Start

May 1, 2011

Primary Completion

July 1, 2012

Study Completion

January 1, 2014

Last Updated

January 20, 2014

Record last verified: 2014-01

Locations

US(1)