New York, New York 10032

  • Multiple Pregnancy

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.


Study summary:

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


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


NCT ID:

NCT01360905


Primary Contact:

Principal Investigator
Fadi Mizra, Dr
New York Presbytarian Hospital


Backup Contact:

N/A


Location Contact:

New York, New York 10032
United States

Sabine Z Bousleiman, RN MSN
Phone: 212-305-2862
Email: sb1080@mail.cumc.columbia.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: December 07, 2022

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.