Study to Support Fetal Heart Rate and Uterine Contraction for Preterm Labor in Singleton and Multiple Pregnancies

Multiple Pregnancy Clinical Trial

Official title:

Study to Determine the Equivalence of the Monica AN24 Monitor to Predicate Devices for (FHR) and (UC) During Pre-term Labor and Multiples

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01360905
• Other study ID #: 100_CT-045
• Status: Terminated
• Phase: N/A
• First received: May 24, 2011
• Last updated: January 17, 2014
• Start date: May 2011
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: Monica Healthcare Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

Clinical Investigation for a non-inferiority/equivalence study that aims to determine the acceptable performance of the Monica AN24 during the first and when possible the second stages of labor by determining whether the Monica AN24 fetal heart rate (FHR) and uterine contractions (UC) monitoring device is non-inferior/equivalent to Doppler FHR and tocodynamometer UC using direct fetal scalp electrode (FSE) FHR and intrauterine pressure catheter (IUPC) UC as a reference, either collected simultaneously with the Monica and Doppler FHR/tocodynamometer UC data, or from previous studies to define the expected accuracy and success rate when comparing Monica FHR and UC with Doppler FHR and tocodynamometer UC respectively

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: January 2014
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• 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

• She has none of the exclusion criteria

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Multiple Pregnancy
• Obstetric Labor, Premature
• Pre Term Labor
• Premature Birth

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Monica Healthcare Ltd	New York Presbyterian Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	equivalence with predicate device		12 months	No