NCT02648867

Evaluation of Maternal Feedback to Shorten Pushing Efforts During Labor

Evaluation of Continuous Maternal Feedback to Shorten Second Stage Labor

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Clinical Innovations, LLC · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Prolonged Second Stage of Labor

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2016-01-07
• Last updated: 2017-07-21

Locations

3 sites across 1 country: United States