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Completed

NCT Number: NCT01280357

Accuracy and Reliability of Fetal Heart Rate and Uterine Contraction Monitoring Method

Clinical Investigation Protocol for a study designed to determine the equivalence of the Monica AN24 monitor to Philips 50XM for fetal heart rate (FHR) and uterine contraction (UC) monitoring during labor. The study will be carried out on subjects in the first and second stages of labor.

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Key information

Conditions

Pregnancy; Habitual Aborter Abortion, Habitual Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases Weeks of Gestation 37 or More

Age range

15 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Queens Hospital Center, New York, United States

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About this study

The study is a prospective, randomized, single-center observational study designed to compare the Fetal Heart Rate (FHR) and Uterine Activity (UA) output data obtained by the Monica AN24 monitor during the first and second stages of labor to those generated by existing FDA-approved devices.Patients were enrolled at the facility but the patient details were removed from the results in order that the data could be randomized for the statistical analysis.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant, age 15-40
  • Term gestation (>36 completed weeks)
  • Singleton fetus
  • Active labor
  • Vertex presentation
  • Requiring internal monitoring

Exclusion criteria

  • Clinical contraindication for Intra Uterine Pressure Catheter
  • Major fetal malformation

Treatment and study plan

Monica AN24 (K101081)

Device

If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM

Other names: Philips Series 50XM (K954351)

Philips 50XM

Device

If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM

Primary outcomes

  1. The Mean Positive Percentage Agreement (PPA) for Fetal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM

    Time frame: during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour

    During Labor & delivery, fetal heart rate was measured between the Monica AN24 & the Philips 50XM and the waveforms of the 2 devices were measured to see the percentage of time they were in agreement.

  2. The Mean Positive Percentage Agreement (PPA) for Maternal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM

    Time frame: during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour

    During Labor & delivery, maternal heart rate was measured between the Monica AN24 & the Philips 50XM and the waveforms of the 2 devices were measured to see the percentage of time they were in agreement.

Secondary outcomes

  1. The Mean Positive Percentage Agreement for Uterine Contractions Between the Monica AN24 & The Philips 50XM

    Time frame: between 35 mins & 15hrs during first & second stage labor

    During labor and delivery uterine contractions were measured between the Monica AN24 & the philips 50XM, the waveforms of the two devices were measured to see the percentage of time they were in agreement

Sponsors and collaborators

Lead sponsor

Monica Healthcare Ltd

Industry

Registry information

Official study title

Study to Determine Substantial Equivalence of Electrohysterography (EHG) Monitoring to Tocodynanometer Monitoring

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 20, 2011
Registry last updated
Mar 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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