Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-01-31 @ 3:41 AM
Study NCT ID:
NCT02697994
Status:
COMPLETED
Last Update Posted:
2016-03-03
First Post:
2016-02-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sterile Water Injections For Pain Relief İn Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-10-07', 'releaseDate': '2016-08-13'}], 'estimatedResultsFirstSubmitDate': '2016-08-13'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}, {'id': 'D001416', 'term': 'Back Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-02', 'studyFirstSubmitDate': '2016-02-09', 'studyFirstSubmitQcDate': '2016-03-02', 'lastUpdatePostDateStruct': {'date': '2016-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain scores-30', 'timeFrame': 'at 30 mins after interventions', 'description': 'In pain scoring Visual Analog Scale was used'}], 'secondaryOutcomes': [{'measure': 'Pain scores-10', 'timeFrame': 'at 10 mins after interventions', 'description': 'In pain scoring Visual Analog Scale was used'}, {'measure': 'Pain scores-60', 'timeFrame': 'at 60 mins after interventions', 'description': 'In pain scoring Visual Analog Scale was used'}, {'measure': 'Pain scores-90', 'timeFrame': 'at 90 mins after interventions', 'description': 'In pain scoring Visual Analog Scale was used'}, {'measure': 'Pain scores-120', 'timeFrame': 'at 120 mins after interventions', 'description': 'In pain scoring Visual Analog Scale was used'}, {'measure': 'Pain scores-180', 'timeFrame': 'at 180 mins after interventions', 'description': 'In pain scoring Visual Analog Scale was used'}, {'measure': 'APGAR score of neonate', 'timeFrame': 'at 5 mins after birth'}, {'measure': 'Maternal satisfaction', 'timeFrame': 'at 1 hour after birth', 'description': 'Likelihood to use again with subsequent labour, Women satisfaction with analgesic effect, Likelihood to recommend to SWI to others'}, {'measure': 'Rates of breastfeeding-1', 'timeFrame': 'at 1 hour after birth', 'description': 'In breastfeed scoring The Infant Breastfeeding Assessment Tool was used'}, {'measure': 'Rates of breastfeeding-24', 'timeFrame': 'at 24.hours after birth', 'description': 'In breastfeed scoring The Infant Breastfeeding Assessment Tool was used'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sterile Water Injection', 'Midwifery'], 'conditions': ['Labour Pain', 'Back Pain']}, 'descriptionModule': {'briefSummary': 'ABSTRACT Introduction: In addition to pain caused by uterine contractions in labour, in 33% of women, continuous and severe back pain is observed. In management of this pain, sterile water injection is considered to be an effective method. Aim of this study is assessment of effectiveness and satisfaction of this method among Turkish women in which analgesic methods are not extensively used in labour and rates of cesarean section exponentially increases.\n\nMaterial and Methods: 168 termed, healthy women who admitted to Istanbul Gaziosmanpaşa-Taksim Training and Research Hospital with labour pain and had severe back pain were randomized into 4x0.1 ml sterile water and 4xdry Injection groups. Injections were applied to Michaelis Rhomboid region in sacral region. Pain scores were assessed at 10th, 30th, 60th, 120th and 180th minutes with Visual Analog Scale (VAS). Additionally, need for epidural analgesia, APGAR score, mode of delivery, time of delivery, maternal satisfaction and breastfeeding scores were assessed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 18-35\n* 37-42 weeks of gestation\n* Expecting vaginal delivery\n* Cephalic presentation\n* Single, healthy fetus\n* Spontaneous onset of labor\n* Active phase of first stage of labor (3-7 cm cervical dilatation)\n* Severe low back pain (VAS\\>7cm)\n* Required pain relief\n\nExclusion Criteria:\n\n* Gestation \\<37 weeks\n* Multiple pregnancy\n* Malpresentation\n* Second stage labour\n* Pharmacological analgesia prior to SWI\n* Back pain assessed by VAS \\<7\n* Women whose labour would be considered high risk'}, 'identificationModule': {'nctId': 'NCT02697994', 'briefTitle': 'Sterile Water Injections For Pain Relief İn Labor', 'organization': {'class': 'OTHER', 'fullName': 'University of Beykent'}, 'officialTitle': 'Intradermal Sterile Water Injections for Labour Pain: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'SWI1315'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sterile Water Injection', 'description': 'Participants randomised to the intervention group received 4 intracutaneous injections of 0.1 ml sterile water into the skin surrounding the Michaelis rhomboid over the sacral area.', 'interventionNames': ['Other: Sterile Water']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dry Injection', 'description': 'Participants in the control group received 4 dry injections in the same region using an insulin needle .', 'interventionNames': ['Other: Dry Injections']}], 'interventions': [{'name': 'Sterile Water', 'type': 'OTHER', 'description': '0.1 ml intracutaneous sterile water injections into the skin surrounding the Michaelis rhomboid over the sacral area.', 'armGroupLabels': ['Sterile Water Injection']}, {'name': 'Dry Injections', 'type': 'OTHER', 'description': 'dry injections into the skin surrounding the Michaelis rhomboid over the sacral area.', 'armGroupLabels': ['Dry Injection']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Beykent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assist.prof.', 'investigatorFullName': 'refika genç koyucu', 'investigatorAffiliation': 'University of Beykent'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-08-13', 'type': 'RELEASE'}, {'date': '2016-10-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'refika genç koyucu, assist.prof., University of Beykent'}}}}