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

Study to Determine the Equivalence of the Monica AN24 Monitor to Predicate Devices for (FHR) and (UC) During Pre-term Labor and Multiples

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01360905

Enrollment

Registered

2011-05-26

Start date

2011-05-31

Completion date

2014-01-31

Last updated

2014-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Pregnancy, Pre Term Labor

Keywords

PTL, Multiples

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.

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

17 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
equivalence with predicate device	12 months

Countries

United States

Outcome results