Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2026-01-31 @ 11:25 AM
Study NCT ID:
NCT02493192
Status:
UNKNOWN
Last Update Posted:
2015-07-09
First Post:
2015-06-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Birth Ball Versus Meperidine and Haloperidol Injection for Pain Relief During First Stage of Labour
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008614', 'term': 'Meperidine'}, {'id': 'D006220', 'term': 'Haloperidol'}], 'ancestors': [{'id': 'D007540', 'term': 'Isonipecotic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D002090', 'term': 'Butyrophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-08', 'studyFirstSubmitDate': '2015-06-23', 'studyFirstSubmitQcDate': '2015-07-08', 'lastUpdatePostDateStruct': {'date': '2015-07-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain', 'timeFrame': '24 months', 'description': 'We use a numeric scale, since 0 ( no pain) to 10 (the greatest pain), to measure this item. We use it with women in the first stage of labour, with labor pain'}], 'secondaryOutcomes': [{'measure': 'Baby´s apgar', 'timeFrame': '24 months', 'description': 'We use the apgar Test to measure this item. Since 0 to 10.We use it after birth, with babies of women who are in our study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Parturition', 'Humanizing Deliver', 'Labor Pain', 'Natural Childbirth', 'Labor Onset', 'First Labor Stage', 'Birth ball', 'meperidine', 'pethidine'], 'conditions': ['Parturition', 'Humanizing Deliver', 'Labor Pain', 'Natural Childbirth', 'Labor Onset', 'First Labor Stage']}, 'referencesModule': {'references': [{'pmid': '23878201', 'type': 'BACKGROUND', 'citation': 'Leung RW, Li JF, Leung MK, Fung BK, Fung LC, Tai SM, Sing C, Leung WC. Efficacy of birth ball exercises on labour pain management. Hong Kong Med J. 2013 Oct;19(5):393-9. doi: 10.12809/hkmj133921. Epub 2013 Jul 22.'}, {'pmid': '23252582', 'type': 'BACKGROUND', 'citation': 'Schult TM, Awosika ER, Schmunk SK, Hodgson MJ, Heymach BL, Parker CD. Sitting on stability balls: biomechanics evaluation in a workplace setting. J Occup Environ Hyg. 2013;10(2):55-63. doi: 10.1080/15459624.2012.748324.'}, {'pmid': '21885314', 'type': 'BACKGROUND', 'citation': 'Delgado-Garcia BE, Orts-Cortes MI, Poveda-Bernabeu A, Caballero-Perez P. [Randomised controlled clinical trial to determine the effects of the use of birth balls during labour]. Enferm Clin. 2012 Jan-Feb;22(1):35-40. doi: 10.1016/j.enfcli.2011.07.001. Epub 2011 Aug 31. Spanish.'}, {'pmid': '21459499', 'type': 'BACKGROUND', 'citation': 'Gau ML, Chang CY, Tian SH, Lin KC. Effects of birth ball exercise on pain and self-efficacy during childbirth: a randomised controlled trial in Taiwan. Midwifery. 2011 Dec;27(6):e293-300. doi: 10.1016/j.midw.2011.02.004. Epub 2011 Apr 3.'}, {'pmid': '21429078', 'type': 'BACKGROUND', 'citation': 'Taavoni S, Abdolahian S, Haghani H, Neysani L. Effect of birth ball usage on pain in the active phase of labor: a randomized controlled trial. J Midwifery Womens Health. 2011 Mar-Apr;56(2):137-40. doi: 10.1111/j.1542-2011.2010.00013.x. Epub 2011 Feb 28.'}]}, 'descriptionModule': {'briefSummary': 'The study was performed at Gregorio Marañón Hospital birth centre. A Randomised Clinical Trial comparing the two methods of pain relief in the first time of labour was carried out. In this study, 110 women in the first stage of labour were allocated in two study groups by a randomised block design. One of them used the birth ball as a pain relief method,and the other one used pethidine and haloperidol injection.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy pregnant women\n* women in the first stage of labour or women at induction of labour\n* fetal head in pelvis or whole amniotic membranes\n* must be able to understand spanish\n\nExclusion Criteria:\n\n* intrapartum meconium\n* needed of continuous fetal monitoring\n* suspecte/compromise fetal wellbeing\n* morbidly obese women\n* unaccompanied women'}, 'identificationModule': {'nctId': 'NCT02493192', 'briefTitle': 'Birth Ball Versus Meperidine and Haloperidol Injection for Pain Relief During First Stage of Labour', 'organization': {'class': 'OTHER', 'fullName': 'Hospital General Universitario Gregorio Marañon'}, 'orgStudyIdInfo': {'id': 'V03_020911'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Meperidine', 'description': 'Use pethidine and haloperidol injection as a pain relief.', 'interventionNames': ['Drug: pethidine and haloperidol injection']}, {'type': 'EXPERIMENTAL', 'label': 'birth ball', 'description': 'Use birth ball as a pain relief.', 'interventionNames': ['Other: birth ball']}], 'interventions': [{'name': 'pethidine and haloperidol injection', 'type': 'DRUG', 'otherNames': ['meperidine and haloperidol injection'], 'armGroupLabels': ['Meperidine']}, {'name': 'birth ball', 'type': 'OTHER', 'otherNames': ['fit ball, swiss ball'], 'armGroupLabels': ['birth ball']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'contacts': [{'name': 'Julita Fernández', 'role': 'CONTACT', 'email': 'julitadelfin@gmail.com', 'phone': '620409480'}], 'facility': 'Hospital Universitario Gregorio Marañón', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Julita Arranz, mcc', 'role': 'CONTACT', 'email': 'julitadelfin@gmail.com', 'phone': '620409480'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital General Universitario Gregorio Marañon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Julita Fernández Arranz', 'investigatorFullName': 'Julia Fernandez', 'investigatorAffiliation': 'Hospital General Universitario Gregorio Marañon'}}}}