Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT04303702
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2020-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Role of Oxytocin in the Second Stage of Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-12', 'studyFirstSubmitDate': '2020-03-06', 'studyFirstSubmitQcDate': '2020-03-06', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Second stage duration', 'timeFrame': 'During admission for delivery', 'description': 'Time interval from complete cervical dilation to delivery of fetus'}], 'secondaryOutcomes': [{'measure': 'Rate of operative delivery', 'timeFrame': 'During admision for delivery', 'description': 'Rate of cesarean section and operative vaginal delivery including forcep or vacuum'}, {'measure': 'Rate of Postpartum hemorrhage', 'timeFrame': 'During admission for delivery', 'description': 'Estimated blood loss \\>500 mL for vaginal delivery and \\>1000 mL for cesarean delivery'}, {'measure': 'Estimated blood loss', 'timeFrame': 'During admission for delivery', 'description': 'Estimated blood loss at time of delivery (mL)'}, {'measure': 'Rate of chorioamnionitis during the second stage of labor', 'timeFrame': 'During admission for delivery', 'description': 'Chorioamnionitis diagnosed at discretion of primary provider during the second stage of labor'}, {'measure': 'Rate of endometritis', 'timeFrame': 'During admission for delivery', 'description': 'Postpartum endometritis as diagnosed by primary provider'}, {'measure': 'Rate of severe perineal laceration', 'timeFrame': 'During admission for delivery', 'description': '3rd or 4th degree perineal laceration'}, {'measure': 'Rate of composite neonatal morbidity', 'timeFrame': 'During admission for delivery', 'description': '1 or more of the following: death, birth injury, umbilical artery acidosis, respiratory distress, transient tachypnea, meconium aspiration with pulmonary hypertension, hypoxic-ischemic encephalopathy, hypoglycemia, hypothermia treatment, or suspected neonatal sepsis.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Labor Complication']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial investigating the utility of oxytocin administration in the second stage of labor.', 'detailedDescription': 'Oxytocin is widely used on Labor and Delivery units throughout the world.Laboring patients are most likely to initiate oxytocin in the first stage of labor. Among those who receive oxytocin, first stage initiation is far more common than second stage initiation. The goal of first stage administration is to increase uterine contractility and cause cervical dilation, particularly in patients who have epidural analgesia. Once complete cervical dilation has been achieved, most providers choose to continue oxytocin in the second stage of labor for the theoretic benefit of increased expulsion "power" while pushing. This practice is currently not evidence-based as the limited data thus far suggests no difference in operative deliveries with the use of oxytocin augmentation in general. The benefits and risk of oxytocin continuation in the second stage of labor is unknown. Oxytocin administration is associated with the risk of uterine tachysystole, postpartum hemorrhage,and maternal hyponatremia. These risks call for a closer look at prolonged oxytocin use past the first stage of labor. This is a randomized controlled trial investigating the utility of oxytocin administration in the second stage of labor.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nulliparous pregnant women \\>/= 37 weeks gestation\n* Singleton pregnancies\n* Admission for induction of labor or spontaneous labor\n\nExclusion Criteria:\n\n* Multiple gestations\n* Multiparous patients\n* Patients with major fetal anomalies\n* Not on oxytocin at the time of complete cervical dilation\n* Patients with fetal head visible at the perineum on diagnosis of complete cervical dilation\n* Maternal medical condition that prohibits prolonged second stage'}, 'identificationModule': {'nctId': 'NCT04303702', 'acronym': 'ROSSoL', 'briefTitle': 'The Role of Oxytocin in the Second Stage of Labor', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Role of Oxytocin in the Second Stage of Labor: a Randomized Controlled Trial (The ROSSoL Trial)', 'orgStudyIdInfo': {'id': '201909112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Discontinue Oxytocin', 'interventionNames': ['Other: Discontinue Oxytocin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Continue Oxytocin', 'interventionNames': ['Drug: Continue Oxytocin']}], 'interventions': [{'name': 'Continue Oxytocin', 'type': 'DRUG', 'description': 'The administration and titration of oxytocin for labor augmentation is per a hospital based protocol. To summarize, oxytocin is initiated intravenously at 2 milliunits/minute and increased by 2 milliunits/minute every 20 minutes until an adequate contraction pattern is attained or a maximum of 40 millunits/minute has been achieved. This protocol for titration and administration will be applied in this study to the oxytocin group. The intravenous pumps on Labor and Delivery have automated functions for intravenous administration of oxytocin that is milliunit-based and the same routine pumps will be used in this study. The study bag will be administered per current oxytocin protocol. Since patients will already be on oxytocin at time of randomization, their current bag of oxytocin will be continued by the primary provider at a rate of their discretion.', 'armGroupLabels': ['Continue Oxytocin']}, {'name': 'Discontinue Oxytocin', 'type': 'OTHER', 'description': 'Patients will have their oxytocin discontinued in the second stage of labor. The patient will receive routine maintenance IV fluids per the discretion of the provider.', 'armGroupLabels': ['Discontinue Oxytocin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nandini Raghuraman, MD MS', 'role': 'CONTACT', 'email': 'raghuramann@wudosis.wustl.edu', 'phone': '918-691-7389'}], 'facility': 'Barnes Jewish Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'centralContacts': [{'name': 'Nandini Raghuraman, MD MSCI', 'role': 'CONTACT', 'email': 'nraghuraman@wustl.edu', 'phone': '9186917389'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Michigan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Nandini Raghuraman', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}