Evaluation of Maternal Feedback to Shorten Pushing Efforts During Labor
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2015 |
| End Date: | December 2016 |
| Contact: | Ross W McQuivey, M.D. |
| Email: | r.mcquivey@clinicalinnovations.com |
| Phone: | (801)260-6097 |
Evaluation of Continuous Maternal Feedback to Shorten Second Stage Labor
This study will assess the ability for continuous electronic feedback to reduce the length
of second stage labor and improve maternal and fetal outcomes.
of second stage labor and improve maternal and fetal outcomes.
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.
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.
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).
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301 University Blvd
Galveston, Texas 77555
Galveston, Texas 77555
(409) 772-1011
Phone: 409-747-0476
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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Salt Lake City, Utah 84157
Principal Investigator: Sean Esplin, MD
Phone: 801-507-7400
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