Study to Support Fetal Heart Rate and Uterine Contraction for Preterm Labor in Singleton and Multiple Pregnancies
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ClinicalTrials.gov Identifier: NCT01360905
Recruitment Status :
(Difficulty in recruiting)
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 LaborMultiple Pregnancy
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
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Ages Eligible for Study:
17 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
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