Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:23 AM
Study NCT ID:
NCT07474350
Status:
COMPLETED
Last Update Posted:
2026-03-16
First Post:
2026-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Valethamate Bromide Versus Hyoscine Butyl Bromide in Reducing Labour Duration Among Primigravida
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'C004904', 'term': 'valethamate'}, {'id': 'D002086', 'term': 'Butylscopolammonium Bromide'}], 'ancestors': [{'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-03-11', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of cervical dilatation', 'timeFrame': '8hours', 'description': 'This was the rate of dilation of the cervix per hour in patients in active phase of labour'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Valethamate bromide', 'Hyoscine butyl bromide', 'Primigravida', 'Labour duration'], 'conditions': ['Labour Duration', 'Primigravida']}, 'descriptionModule': {'briefSummary': 'Labour is a physiological process that enables the natural delivery of fetus, placenta and membranes after the age of viability.\n\nThis study compared the efficacy of valethamate bromide and hyoscine butyl bromide in reducing labour duration among primigravid women at Alex Ekwueme Federal University Teaching Hospital, Abakaliki', 'detailedDescription': "Labour is a physiological process that enables the natural delivery of fetus, placenta and membranes after the age of viability. When labour is prolonged, it may defeat the whole essence of pregnancy as a result of poor outcome. Efforts have been made to prevent prolonged labour which includes the use of certain medications such as hyoscinebutyl bromide and valethamate bromide. However, there is paucity of studies comparing the effectiveness of both drugs, which could provide a better choice of reducing labour duration and its attendants' complications.\n\nAIM:\n\nThis study compared the efficacy of valethamate bromide and hyoscine butyl bromide in reducing labour duration among primigravid women at Alex Ekwueme Federal University Teaching Hospital, Abakaliki.\n\nRESEARCH METHOD:\n\nThis was a randomized controlled study where equal members of primigravid women at term were recruited and received 8 mg (2 ml) of valethamatebromide;20 mg (2 ml) of hyoscine butyl bromideand 2ml of sterile water.\n\nEither valethamate bromide 8mg, hyoscine butyl bromide20mg and no intervention (2 ml of sterile water) were given intravenously to the women who met the criteria. The data obtained were analyzed using statistical package for social science (SPSS) software (version 2022, Chicago II, USA). Categorical variables were presented as numbers and percentages while continuous variables were presented as mean and standard deviation (mean + 25D). Logistic regression was used where appropriate. A difference with a P value of ≤ 0.05 was taken to be statistically significant."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primigravidae / nulliparae.\n* Singleton term pregnancy with no evidence of maternal or fetal distress.\n* Women with fetus in cephalic presentation.\n* Age: 18- 35 years.\n* Women with no contra-indications to vaginal delivery.\n* Cervical dilatations of 4- 9cm when in labour\n* Spontaneous or induced labour.\n* Patients on epidural analgesia\n\nExclusion Criteria:\n\n* Multiple gestations.\n* Women with abnormal fetal presentation.\n* Absolute indications for caesarean section.\n* Antepartum hemorrhage.\n* Evidence of maternal or fetal distress.\n* Fibroid in pregnancy.\n* Grand multiparous patients.\n* Previous uterine scar/ surgery or ruptures.\n* Medical disorders of pregnancy like pre-eclempsia, Eclempsia, Dm etc.\n* If any other antispasmodics agent had been used within the last 48 hours.\n* Preterm/ term premature rupture of membranes.\n* History of cervical injury/ surgery.\n* Hypersensitivity to valethamate bromide and/or hyoscine butyl bromide'}, 'identificationModule': {'nctId': 'NCT07474350', 'briefTitle': 'Valethamate Bromide Versus Hyoscine Butyl Bromide in Reducing Labour Duration Among Primigravida', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Federal Teaching Hospital Abakaliki'}, 'officialTitle': 'Valethamate Bromide Versus Hyoscine Butyl Bromide in Reducing Labour Duration Among Primigravida: A Randomised Controlled Trial.', 'orgStudyIdInfo': {'id': 'AE FUTHA/REC/VOL3/2023/236'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Valethamate', 'description': 'Group I received 2ml (16mg) of valethamate bromide intravenously, when patient is in active phase of labour.', 'interventionNames': ['Drug: Valethamate Bromide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hyoscine', 'description': 'Group II received 2ml (40mg) of hyoscine butyl bromide intravenously when patient is in active phase of labour.', 'interventionNames': ['Drug: Hyoscine butylbromide']}, {'type': 'SHAM_COMPARATOR', 'label': 'Water', 'description': 'Group III received 2ml of sterile water for injection when patient is in active phase of labour', 'interventionNames': ['Other: Sterile water']}], 'interventions': [{'name': 'Valethamate Bromide', 'type': 'DRUG', 'description': 'Two ml (16mg) of valethamate bromide was given intravenously to the patient who has attained active phase labour parameters', 'armGroupLabels': ['Valethamate']}, {'name': 'Hyoscine butylbromide', 'type': 'DRUG', 'description': 'Two ml (40mg) of hyoscine butylbromide was given intravenously to the patient who has attained active phase labour parameters', 'armGroupLabels': ['Hyoscine']}, {'name': 'Sterile water', 'type': 'OTHER', 'description': 'Two ml of water was given intravenously to the patient who has attained active phase labour parameters', 'armGroupLabels': ['Water']}]}, 'contactsLocationsModule': {'locations': [{'zip': '480101', 'city': 'Abakaliki', 'state': 'Ebonyi State', 'country': 'Nigeria', 'facility': 'Alex Ekwueme Federal University Teaching Hospital', 'geoPoint': {'lat': 6.32485, 'lon': 8.11368}}], 'overallOfficials': [{'name': 'Assumpta N Nweke', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alex Ekwueme Federal University Teaching Hospital Abakaliki Ebonyi State'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This will be after publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal Teaching Hospital Abakaliki', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Assumpta Nnenna Nweke', 'investigatorAffiliation': 'Federal Teaching Hospital Abakaliki'}}}}