Evaluation of Maternal Feedback to Shorten Pushing Efforts During Labor

Not Applicable

Terminated

• Conditions: Prolonged Second Stage of Labor
• Interventions: Device: Continuous Maternal Feedback

• Registration Number: NCT02648867
• Lead Sponsor: Clinical Innovations, LLC

Brief 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.

Detailed Description

The length of the second stage (pushing stage) of labor is highly correlated with the incidence of adverse outcomes for mother and neonate. More than 80% of laboring women in the US have epidurals for labor pain management. The length of second stage labor is increased in women receiving regional anesthesia for pain management during labor and delivery compared to women without anesthesia. This increased length of labor is largely due to lack of maternal sensation resulting in decreased physiologic feedback on the efficacy of maternal expulsive (pushing) efforts. Continuous maternal feedback regarding fetal decent during labor may result in more effective maternal expulsive efforts reducing the length of second stage and improving maternal and neonatal outcomes. This study will assess the ability for continuous electronic feedback to reduce the length of second stage labor and improve maternal and fetal outcomes.

The study 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 the FSE. As the patient pushes, the amount of fetal movement will be measured and recorded. The movement will be recorded by a laptop computer which will provide optical and auditory feedback to the patient about descent of the fetal head with maternal expulsive efforts.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-01-03
• Study First Submitted QC: 2016-01-05
• Study First Posted: 2016-01-07
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

1. Laboring nulliparous women who are > 36 0/7 weeks estimated gestational age undergoing epidural or combined spinal epidural (CSE) placement for labor pain management.

Exclusion Criteria

1. Women with multiple gestations.
2. Women with contraindications to pushing during second stage labor.
3. Women with contraindications to Fetal Spiral Electrode (FSE) placement including women with a face or compound presentation, known HIV, Hepatitis B or Active Herpes.
4. Women who do not plan to initiate pushing immediately (those who plan to "rest and descend" prior to initiation of pushing).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients receiving PushCoach feedback	Continuous Maternal Feedback	Patients will receive continuous maternal feedback from the PushCoach device, which includes both audio and visual feedback of fetal head movement during the second stage of labor
Patients blinded to PushCoach feedback	Continuous Maternal Feedback	Patients will not receive continuous maternal feedback from the PushCoach device (it will be in place and collect data), but will receive normal feedback from the clinician during the second stage of labor.

Primary Outcome Measures

Name	Time	Method
Length of second stage labor in patients using the PushCoach device compared to patients blinded to the PushCoach device output	Second stage of labor begins once the patient's cervix is completely dilated and ends once the baby is delivered. This time will be compared between patients.	The primary objective of this study is to measure the ability of immediate, quantitatively precise, visual, and auditory and haptic maternal feedback on fetal descent to reduce the overall length of second stage labor compared to women receiving standard verbal and manual feedback during second stage labor and reduce the incidence of pushing for longer than 60 minutes.

Trial Locations

Locations (3)

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States

University of Utah Hospital; 🇺🇸 Salt Lake City, Utah, United States

Intermountain Medical Center; 🇺🇸 Salt Lake City, Utah, United States