Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-27 @ 3:01 AM
Study NCT ID:
NCT01720004
Status:
COMPLETED
Last Update Posted:
2012-11-01
First Post:
2012-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Randomized Controlled Trial of Repeated Hands-and-Knees Positioning During Labour
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-30', 'studyFirstSubmitDate': '2012-10-24', 'studyFirstSubmitQcDate': '2012-10-30', 'lastUpdatePostDateStruct': {'date': '2012-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Method of birth', 'timeFrame': 'at delivery', 'description': 'Spontaneous vaginal, assisted vaginal (vacuum or forceps), Caesarean'}, {'measure': 'pharmacologic analgesia', 'timeFrame': 'Initiated during labour', 'description': 'regional analgesia or intramuscular analgesia administered during first or second stage labour'}, {'measure': 'oxytocin during first or second stage labour', 'timeFrame': 'from randomization until end of second stage', 'description': 'any oxytocin infusion'}, {'measure': 'dislodged epidural catheter', 'timeFrame': 'from randomization until delivery', 'description': 'dislodged epidural catheter'}, {'measure': 'Fall', 'timeFrame': 'from randomization until delivery', 'description': 'Mother fell while attempting hands-and-knees position'}, {'measure': 'perineal trauma', 'timeFrame': 'at delivery', 'description': 'any perineal trauma (episiotomy and/or laceration0 requiring suturing'}, {'measure': 'maternal postpartum complications', 'timeFrame': 'between delivery and hospital discharge', 'description': 'postpartum hemorrhage or complication requiring prolonged stay'}, {'measure': 'Apgar Score', 'timeFrame': 'at one and five minutes after birth', 'description': 'Neonatal Apgar Score'}, {'measure': 'length of hospital stay', 'timeFrame': 'from delivery to discharge', 'description': 'length of stay for mother and baby after birth'}, {'measure': 'admission to neonatal intensive care unit', 'timeFrame': 'between birth and hospital discharge', 'description': 'newborn admitted to neonatal intensive care unit'}, {'measure': 'labour length', 'timeFrame': 'from randomization until delivery', 'description': 'Length of time between randomization and delivery'}], 'primaryOutcomes': [{'measure': 'Compliance', 'timeFrame': 'from randomization to delivery', 'description': 'Use of hands-and-knees position for at least 15 minutes hourly during hospital labour.'}], 'secondaryOutcomes': [{'measure': 'Persistent back pain', 'timeFrame': 'hourly during labour, from randomization to delivery', 'description': 'Persistent back pain intensity rating measured hourly during hospital labour.'}, {'measure': "women's views", 'timeFrame': 'assessed prior to hospital discharge', 'description': "women's views of their birth experiences, including satisfaction with care and care providers, views about hands-and-knees positioning, willingness to use hands-and-knees position in a subsequent labour, comparison of expectations versus experiences of labour. The measures used to assess women's views had been developed for and used in prior trials of forms of intrapartum care by Hodnett and colleagues. Most questions were Likert scales or categorical items."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['human labour', 'hands-and-knees positioning', 'pilot trial'], 'conditions': ['Pregnancy, Childbirth and the Puerperium']}, 'descriptionModule': {'briefSummary': "The investigators designed a pilot randomized controlled trial to assess the feasibility and acceptability of repeated hands-and-knees positioning during labour. The objectives were 1) to provide an estimate of enrollment rates, 2) to assess compliance with the study protocol by participants and care providers, 3) to obtain women's views about their experiences using the hands-and-knees position, and 4) to provide estimates of treatment effects to inform the sample size calculation for a large trial.", 'detailedDescription': 'Women were enrolled in the pilot randomized controlled trial at two hospitals, one in Canada and one in the USA. Nurses at both hospitals were trained in how to assist women into the hands-and-knees position in bed. Repeated hands-and-knees position was defined as attempts to use the position for 15 minutes, hourly from randomization until delivery. Women were not asked to assume hands-and-knees for delivery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* nulliparous;\n* \\>37 weeks 0 days gestation\n* in established early labour\n* anticipating a vaginal delivery of a single fetus in the cephalic position\n* competent to give informed consent .\n\nExclusion Criteria:\n\n* delivery was anticipated within 3 hours\n* a medical contraindication or physical limitation such that hands-and- knees position was contraindicated\n* had a doula or midwife who encouraged the use of hands-and-knees position.'}, 'identificationModule': {'nctId': 'NCT01720004', 'acronym': 'LPT2', 'briefTitle': 'A Pilot Randomized Controlled Trial of Repeated Hands-and-Knees Positioning During Labour', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'Repeated Hands-and-Knees Positioning During Labour: A Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IGO-103690'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Repeated Use of Hands-and-Knees', 'description': 'The intervention was repeated use of hands-and-knees position during labour. Participants were asked to try it for at least 15 minutes every hour, from randomization until delivery. They were not required to use it for delivery.', 'interventionNames': ['Other: Repeated hands-and-knees positioning during labour']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Participants were asked to refrain from using hands-and-knees position at any time from randomization to delivery. They were free to use any other position.'}], 'interventions': [{'name': 'Repeated hands-and-knees positioning during labour', 'type': 'OTHER', 'description': 'Details are in the Arm Description.', 'armGroupLabels': ['Repeated Use of Hands-and-Knees']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Health Harris Methodist Hospital', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': 'M4C 3E7', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto East General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ellen Hodnett', 'investigatorAffiliation': 'University of Toronto'}}}}