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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01360905
Recruitment Status : Terminated (Difficulty in recruiting)
First Posted : May 26, 2011
Last Update Posted : January 20, 2014
New York Presbyterian Hospital
Information provided by (Responsible Party):
Monica Healthcare Ltd

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.

Condition or disease
Pre Term Labor Multiple Pregnancy

Detailed 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

Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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
Study Start Date : May 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : January 2014

Primary Outcome Measures :
  1. equivalence with predicate device [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01360905

United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Monica Healthcare Ltd
New York Presbyterian Hospital
Principal Investigator: Fadi Mizra, Dr New York Presbytarian Hospital

Responsible Party: Monica Healthcare Ltd Identifier: NCT01360905     History of Changes
Other Study ID Numbers: 100_CT-045
First Posted: May 26, 2011    Key Record Dates
Last Update Posted: January 20, 2014
Last Verified: January 2014

Keywords provided by Monica Healthcare Ltd:

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications