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

This study has been terminated.
(Difficulty in recruiting)
Sponsor:
Collaborator:
New York Presbyterian Hospital
Information provided by (Responsible Party):
Monica Healthcare Ltd
ClinicalTrials.gov Identifier:
NCT01360905
First received: May 24, 2011
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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
Pre Term Labor
Multiple Pregnancy

Study Type: Observational
Study Design: 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

Further study details as provided by Monica Healthcare Ltd:

Primary Outcome Measures:
  • equivalence with predicate device [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: May 2011
Study Completion Date: January 2014
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders 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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360905

Locations
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
Investigators
Principal Investigator: Fadi Mizra, Dr New York Presbytarian Hospital
  More Information

No publications provided

Responsible Party: Monica Healthcare Ltd
ClinicalTrials.gov Identifier: NCT01360905     History of Changes
Other Study ID Numbers: 100_CT-045
Study First Received: May 24, 2011
Last Updated: January 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Monica Healthcare Ltd:
PTL
Multiples

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

ClinicalTrials.gov processed this record on July 22, 2014