Clinical trial NCT02648867: Evaluation of Maternal Feedback to Shorten Pushing Efforts During Labor
Official title: Evaluation of Continuous Maternal Feedback to Shorten Second Stage Labor
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prolonged Second Stage of Labor
Lead sponsor: Clinical Innovations, LLC
Sponsor class: INDUSTRY
First posted: 2016-01-07
Enrollment: 10
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Length of second stage labor in patients using the PushCoach device compared to patients blinded to the PushCoach device output
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Salt Lake City
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Michael S Esplin, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah Hospital
name: Erin Clark, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas
name: George Saade, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: McRae-Bergeron CE, Andrews CM, Lupe PJ. The effect of epidural analgesia on the second stage of labor. AANA J. 1998 Apr;66(2):177-82.
citation: Johnson S, Rosenfeld JA. The effect of epidural anesthesia on the length of labor. J Fam Pract. 1995 Mar;40(3):244-7.
citation: Rouse DJ, Weiner SJ, Bloom SL, Varner MW, Spong CY, Ramin SM, Caritis SN, Peaceman AM, Sorokin Y, Sciscione A, Carpenter MW, Mercer BM, Thorp JM Jr, Malone FD, Harper M, Iams JD, Anderson GD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Second-stage labor duration in nulliparous women: relationship to maternal and perinatal outcomes. Am J Obstet Gynecol. 2009 Oct;201(4):357.e1-7. doi: 10.1016/j.ajog.2009.08.003.