Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-02-20 @ 3:39 PM
Study NCT ID:
NCT02648867
Status:
TERMINATED
Last Update Posted:
2017-07-21
First Post:
2016-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Maternal Feedback to Shorten Pushing Efforts During Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Device was unacceptable to patients and did not provide expected outputs', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-18', 'studyFirstSubmitDate': '2016-01-03', 'studyFirstSubmitQcDate': '2016-01-05', 'lastUpdatePostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.", 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prolonged Second Stage of Labor']}, 'referencesModule': {'references': [{'pmid': '9801480', 'type': 'BACKGROUND', '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.'}, {'pmid': '7876781', 'type': 'BACKGROUND', 'citation': 'Johnson S, Rosenfeld JA. The effect of epidural anesthesia on the length of labor. J Fam Pract. 1995 Mar;40(3):244-7.'}, {'pmid': '19788967', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the ability for continuous electronic feedback to reduce the length of second stage labor and improve maternal and fetal outcomes.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Laboring nulliparous women who are \\> 36 0/7 weeks estimated gestational age undergoing epidural or combined spinal epidural (CSE) placement for labor pain management.\n\nExclusion Criteria:\n\n1. Women with multiple gestations.\n2. Women with contraindications to pushing during second stage labor.\n3. Women with contraindications to Fetal Spiral Electrode (FSE) placement including women with a face or compound presentation, known HIV, Hepatitis B or Active Herpes.\n4. Women who do not plan to initiate pushing immediately (those who plan to "rest and descend" prior to initiation of pushing).'}, 'identificationModule': {'nctId': 'NCT02648867', 'briefTitle': 'Evaluation of Maternal Feedback to Shorten Pushing Efforts During Labor', 'organization': {'class': 'INDUSTRY', 'fullName': 'Clinical Innovations, LLC'}, 'officialTitle': 'Evaluation of Continuous Maternal Feedback to Shorten Second Stage Labor', 'orgStudyIdInfo': {'id': 'CI-002-PC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients receiving PushCoach feedback', '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', 'interventionNames': ['Device: Continuous Maternal Feedback']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patients blinded to PushCoach feedback', '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.', 'interventionNames': ['Device: Continuous Maternal Feedback']}], 'interventions': [{'name': 'Continuous Maternal Feedback', 'type': 'DEVICE', 'otherNames': ['PushCoach'], 'description': "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.", 'armGroupLabels': ['Patients blinded to PushCoach feedback', 'Patients receiving PushCoach feedback']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Hospital', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84157', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Intermountain Medical Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Michael S Esplin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Intermountain Health Care, Inc.'}, {'name': 'Erin Clark, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah Hospital'}, {'name': 'George Saade, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinical Innovations, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}