Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT04969120
Status:
COMPLETED
Last Update Posted:
2022-08-02
First Post:
2021-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metoclopramide and the Length of First Stage of Labor , a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008787', 'term': 'Metoclopramide'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], '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': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-01', 'studyFirstSubmitDate': '2021-06-27', 'studyFirstSubmitQcDate': '2021-07-09', 'lastUpdatePostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'duration of labour', 'timeFrame': '8-12 hours', 'description': 'cervical dilatation rate in first stage of labour'}], 'secondaryOutcomes': [{'measure': 'labour pain', 'timeFrame': 'pain assessment at 30,60,120 minutes following injection of metoclopramide', 'description': 'effect of metoclopramide on labour pain score using visual analogue scale which is a score from 0 to 10 cm The higher the score represents more pain'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metoclopramide - labor duration-labor pain'], 'conditions': ['Labour Duration and Metoclopramide']}, '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 childbirth experience.\n\nProlonged labor can lead to increased maternal and neonatal morbidity and mortality such as rupture of the uterus, postpartum hemorrhage, puerperal sepsis, and maternal death. Prolonged labor may be due to maternal age, premature rupture of membrane, epidural analgesia and the secretion of high levels of maternal stress hormones.', 'detailedDescription': 'Several studies showed that active management of labor could shorten the duration of labor, and the safety of this method has been demonstrated.\n\nMetoclopramide binds to dopamine receptors acting as a receptor antagonist, and it is also a mixed serotonin receptor agonist and antagonist.\n\nMetoclopramide could potentially reduce spasms of the smooth muscle of the cervix that remains richly innervated at birth and thus have a regulatory effect on cervical contractility, an interaction that might be important in aiding maximal tissue compliance, promoting cervical dilatation during labor, and helping to reduce dystocia. Dopamine and other catecholamines have been identified in rabbit, rat, guinea-pig, sheep, and human uteri.\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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primigravida\n* singleton pregnancy\n* termgestation (37-42 weeks)\n* sure reliable dated\n* vertex presentation , occipito-anterior position\n* regular uterine contractions at every 5 minutes,each lasting for 20 seconds\n* cervical dilatation of 5 cm\n* with or without rupture of membrane\n* no evidence of maternal or fetal distress\n\nExclusion Criteria:\n\n* chorioamnionitis\n* scarred uterus e.g. myomectomy\n* cephalopelvic dispropotion\n* history of cervical surgery or injury\n* hypersensitivity to metoclopramide'}, 'identificationModule': {'nctId': 'NCT04969120', 'briefTitle': 'Metoclopramide and the Length of First Stage of Labor , a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Effect of Metoclopramide on the Length of First Stage of Labor in Nulliparous Women, a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Metoclopramide and labour'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '(group 1) receiving intravenous metoclorpramide', 'description': 'this group receive 10mg intravenous metoclopramide', 'interventionNames': ['Drug: Metoclopramide 10mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': '(group 2) receiving placebo', 'description': 'this group receive 10mg intravenous placebo(0.9 sodium chloride)', 'interventionNames': ['Drug: Placebo (0.9 sodium chloride)']}], 'interventions': [{'name': 'Metoclopramide 10mg', 'type': 'DRUG', 'description': 'this group receive 10mg intravenous metoclopramide slowly over 2 minutes the medication will be repeated every 2 hours for a maximum three doses', 'armGroupLabels': ['(group 1) receiving intravenous metoclorpramide']}, {'name': 'Placebo (0.9 sodium chloride)', 'type': 'DRUG', 'description': 'this group receive 10mg intravenous placebo(0.9 sodium chloride) slowly over 2 minutes the medication will be repeated every 2 hours for a maximum three doses', 'armGroupLabels': ['(group 2) receiving placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Obstetrics and gynecology department at kasralainy hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Obstetrics and gynecology at Cairo university', 'investigatorFullName': 'Shaimaa Mostafa Mohammed Refaay El shemy', 'investigatorAffiliation': 'Cairo University'}}}}