Study Stopped
Device was unacceptable to patients and did not provide expected outputs
Evaluation of Maternal Feedback to Shorten Pushing Efforts During Labor
Evaluation of Continuous Maternal Feedback to Shorten Second Stage Labor
1 other identifier
interventional
10
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2015
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 3, 2016
CompletedFirst Posted
Study publicly available on registry
January 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJuly 21, 2017
July 1, 2017
6 months
January 3, 2016
July 18, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Length of second stage labor in patients using the PushCoach device compared to patients blinded to the PushCoach device output
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.
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.
Study Arms (2)
Patients receiving PushCoach feedback
EXPERIMENTALPatients 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
ACTIVE COMPARATORPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- \. Laboring nulliparous women who are \> 36 0/7 weeks estimated gestational age undergoing epidural or combined spinal epidural (CSE) placement for labor pain management.
You may not qualify if:
- Women with multiple gestations.
- Women with contraindications to pushing during second stage labor.
- Women with contraindications to Fetal Spiral Electrode (FSE) placement including women with a face or compound presentation, known HIV, Hepatitis B or Active Herpes.
- Women who do not plan to initiate pushing immediately (those who plan to "rest and descend" prior to initiation of pushing).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of Texas Medical Branch
Galveston, Texas, 77555, United States
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
Intermountain Medical Center
Salt Lake City, Utah, 84157, United States
Related Publications (3)
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.
PMID: 9801480BACKGROUNDJohnson S, Rosenfeld JA. The effect of epidural anesthesia on the length of labor. J Fam Pract. 1995 Mar;40(3):244-7.
PMID: 7876781BACKGROUNDRouse 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.
PMID: 19788967BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Michael S Esplin, M.D.
Intermountain Health Care, Inc.
- PRINCIPAL INVESTIGATOR
Erin Clark, M.D.
University of Utah Hospital
- PRINCIPAL INVESTIGATOR
George Saade, M.D.
University of Texas
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2016
First Posted
January 7, 2016
Study Start
December 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
July 21, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share