Evaluation of Maternal Feedback to Shorten Pushing Efforts During Labor

Clinical Innovations

Status: Terminated

Conditions: Prolonged Second Stage of Labor

Treatments: Device: Continuous Maternal Feedback

Study type: Interventional

Funder types: Industry

Identifiers

NCT02648867

CI-002-PC

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Patients receiving PushCoach feedback

Experimental group

Description:

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

Treatment:

Device: Continuous Maternal Feedback

Patients blinded to PushCoach feedback

Active Comparator group

Description:

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.

Treatment:

Device: Continuous Maternal Feedback