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