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Evaluation of Maternal Feedback to Shorten Pushing Efforts During Labor

NCT02648867 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-07-21

No results posted yet for this study

Summary

This study will assess the ability for continuous electronic feedback to reduce the length of second stage labor and improve maternal and fetal outcomes.

Conditions

  • Prolonged Second Stage of Labor

Interventions

DEVICE

Continuous Maternal Feedback

The PushCoach device consists of a modification of the standard fetal scalp electrode and a separate apparatus designed to detect movement of the fetal head by detecting movement of an FSE. The PushCoach will be attached to the patient by an adhesive pad over the sacrum and extend between the patient's legs approximately 2-3 inches from the vaginal introitus. It assesses the movement of the FSE attached to the fetal scalp during pushing. The amount of fetal movement will be measured and recorded. The PushCoach device is connected to a laptop computer which will provide optical and auditory feedback to the patient about descent of the fetal head with maternal expulsive efforts.

Sponsors & Collaborators

  • Clinical Innovations, LLC

    lead INDUSTRY

Principal Investigators

  • Michael S Esplin, M.D. · Intermountain Health Care, Inc.

  • Erin Clark, M.D. · University of Utah Hospital

  • George Saade, M.D. · University of Texas

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02648867 on ClinicalTrials.gov