Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-27 @ 10:57 PM
Study NCT ID:
NCT01937234
Status:
COMPLETED
Last Update Posted:
2017-03-10
First Post:
2013-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of an Antiemetic to Shorten the Length of Labor in Nulliparous Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008787', 'term': 'Metoclopramide'}, {'id': 'D010330', 'term': 'Patents as Topic'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D002723', 'term': 'Chlorobenzoates'}, {'id': 'D062425', 'term': 'Hydroxybenzoate Ethers'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D018973', 'term': 'Intellectual Property'}, {'id': 'D007603', 'term': 'Jurisprudence'}, {'id': 'D012926', 'term': 'Social Control, Formal'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-09', 'studyFirstSubmitDate': '2013-09-01', 'studyFirstSubmitQcDate': '2013-09-04', 'lastUpdatePostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Duration of the second stage of labor', 'timeFrame': '2 hours'}, {'measure': 'Duration of the third stage of labor', 'timeFrame': '1 hour'}, {'measure': 'Number of Participants with Adverse Events', 'timeFrame': '24 hours', 'description': 'Adverse effects of metoclopramide:\n\n* Cardiovascular: heart block, bradycardia, heart failure, flushing, hyper or hypotension, supraventricular tachycardia.\n* Central nervous system: Drowsiness, acute dystonic reactions, headache, dizziness, akathisia, confusion, depression, hallucinations, Parkinsonian-like symptoms, suicidal ideation, seizure, tardive dyskinesia\n* Dermatologic: Angioneurotic edema, rash, urticaria\n* Gastrointestinal: Nausea, vomiting, diarrhea\n* Respiratory: Bronchospasm, laryngeal edema (rare), laryngospasm (rare)'}, {'measure': 'Apgar score', 'timeFrame': '10 minutes'}, {'measure': 'Meconium stained liquor', 'timeFrame': '6 hours'}, {'measure': 'Neonatal intensive care unit admission rate', 'timeFrame': '24 hours'}, {'measure': 'Rate of vaginal delivery', 'timeFrame': '12 hours'}, {'measure': 'Number of participants with genital tract injuries', 'timeFrame': '2 hours', 'description': 'genital tract injuries:\n\n* Perineal tears\n* Vaginal tears\n* Cervical tears\n* Perineal hematomas\n* Vaginal hematomas\n* Uterine rupture'}], 'primaryOutcomes': [{'measure': 'Cervical dilatation rate', 'timeFrame': '6 hours'}], 'secondaryOutcomes': [{'measure': 'Duration of the first stage of labor', 'timeFrame': '6 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Prolonged First Stage of Labor']}, 'referencesModule': {'references': [{'pmid': '31609464', 'type': 'DERIVED', 'citation': 'Ellaithy M, Rasheed S, Shafik A, Abees S. Use of an antiemetic to shorten the length of labor in nulliparous women, exploring a potential role of an old drug: A randomized controlled trial. Int J Gynaecol Obstet. 2020 Jan;148(1):72-78. doi: 10.1002/ijgo.12998. Epub 2019 Nov 8.'}]}, 'descriptionModule': {'briefSummary': 'Reducing the length of labor is a highly desirable goal of intrapartum care, both from a perspective of maternal and fetal well-being , and for the providers of the birth services. Avoiding a long , protracted labor entails shorter exposure to pain anxiety and stress and would translate into a major improvement in maternal satisfaction with the child birth experience.\n\nThe purpose of this study is to determine the effectiveness of metoclopramide for reducing the duration of spontaneous labor among nulliparous women managed according to a standard intrapartum protocol.', 'detailedDescription': 'Women who will fulfill the study inclusion and exclusion criteria and agree to be included in the study will be randomized assigned to receive either an intravenous injection of 10mg metoclopramide (Group 1) or the same volume of placebo, i.e. 0.9% sodium chloride (Group2). Randomization will be achieved using computer generated randomization sequences. Allocation will be in 1:1 ratio. Record of group allocation will be maintained by a resident physician whose responsibility is randomization and drawing up the injection, but has no direct involvement in the intrapartum decision making.\n\nAfter through history and physical examination, each participant will take the selected medication slowly IV over 2 min, the assigned medication will be repeated every two hours for a maximum of three doses.\n\nMonitoring of fetal well-being and labor progress with Partographic representation will be performed.\n\nManagement of labor will be according the labor and delivery standard protocol, if labor dilatation will not progress appropriately, i.e. cervical dilatation rate of \\<1cm/hour, amniotomy will be performed if membranes are intact. Oxytocin augmentation will be considered after rupture of membranes only if the cervix remains unchanged on two consecutive pelvic examination conducted two hours apart. Oxytocin infusion will start with 5mIU/min and increase by 5mIU/min every 15min to achieve seven contractions in 15 min, the maximal rate of oxytocin being 30Miu/min.\n\nThe following parameters will be recorded for every patient:\n\n* Timing of metoclopramide or placebo injections\n* Timing of full dilatation of cervix\n* Duration of first stage of labor\n* Duration of second stage of labor\n* Duration of third stage of labor\n* Mode of delivery\n* Injection to delivery interval\n* Cervical dilatation rate\n* Neonatal condition at birth'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primigravida\n* Singleton pregnancy\n* Term gestation i.e. 37- 42 weeks\n* Sure reliable dates\n* Vertex presentation, occipitoanterior position\n* Spontaneous onset of labor\n* Regular uterine contractions at every 5 min ,each lasting for 20 sec\n* Cervical dilatation of 3-5cm\n* With or without rupture of membranes\n* No evidence of maternal or fetal distress\n\nExclusion Criteria:\n\n* Mal-presentations\n* Mal-positions\n* Multifetal pregnancy\n* Cephalopelvic disproportion\n* history of cervical surgery or injury\n* Hypersensitivity to metoclopramide'}, 'identificationModule': {'nctId': 'NCT01937234', 'briefTitle': 'Use of an Antiemetic to Shorten the Length of Labor in Nulliparous Women', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Use of an Antiemetic to Shorten the Length of Labor in Nulliparous Women, Exploring a Potential Role of an Old Drug', 'orgStudyIdInfo': {'id': 'AFHSR-13-7-2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Metoclopramide', 'description': 'Intravenous injection of 10mg metoclopramide', 'interventionNames': ['Drug: Metoclopramide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Intravenous injection of 0.9% sodium chloride', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Metoclopramide', 'type': 'DRUG', 'otherNames': ['Primperan (Trademark)'], 'description': 'Intravenous injection of 10mg metoclopramide, at enrollment, then every 2 hours.\n\nMaximum of 3 doses.', 'armGroupLabels': ['Metoclopramide']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Normal saline'], 'description': 'Intravenous injection of 0.9% sodium chloride, at enrollment, then every 2 hours.\n\nMaximum of 3 doses.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '101', 'city': 'Khamis Mushait', 'state': 'Khamis Mushait', 'country': 'Saudi Arabia', 'facility': 'Labor and delivery ward of Armed Forces Hospital, Southern Region.', 'geoPoint': {'lat': 18.3, 'lon': 42.73333}}], 'overallOfficials': [{'name': 'Mohamed I Ellaithy, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Armed Forces Hospitals, Southern Region, Saudi Arabia', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Obstetrics & Gynecology', 'investigatorFullName': 'Mohamed Ellaithy', 'investigatorAffiliation': 'Ain Shams University'}}}}