Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-29 @ 2:36 PM
Study NCT ID:
NCT04597528
Status:
COMPLETED
Last Update Posted:
2022-03-15
First Post:
2020-10-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Elective Induction of Labour at Thirty Nine Weeks: a Prospective Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 315}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-13', 'studyFirstSubmitDate': '2020-10-01', 'studyFirstSubmitQcDate': '2020-10-15', 'lastUpdatePostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Caesarean Section (CS)', 'timeFrame': 'Till discharge from hospital or upto 4 days from day of delivery whichever is later', 'description': 'Number of participants who underwent CS measured in percentage'}, {'measure': 'Number of neonates requiring intensive care', 'timeFrame': '24 hours from birth', 'description': 'Incidence of admission to neonatal intensive care unit (NICU) requiring cardio respiratory support within the first 24 hours of birth.\n\nCardio respiratory support defined as needing any of the following within the first 24 hours of birth\n\n1. Cardiopulmonary resuscitation (CPR)\n2. invasive mechanical ventilatory care with a definitive airway\n3. high flow nasal cannula (HFNC)\n4. nasal continuous positive airway pressure (CPAP)ventilation'}], 'secondaryOutcomes': [{'measure': 'Time to delivery (induction to delivery time )', 'timeFrame': '24 hours', 'description': 'Time taken from induction of delivery to delivery of the baby measured in hours and minutes'}, {'measure': 'Number of study participants with chorioamnionitis', 'timeFrame': 'Diagnosed at anytime, through delivery, upto 24 hours after birth', 'description': 'Chorioamnionitis, documented as a clinical diagnosis before delivery'}, {'measure': 'Number of participants with Postpartum hemorrhage', 'timeFrame': 'Upto 12 weeks from day of delivery', 'description': 'Postpartum hemorrhage, defined as answering "yes" for any of the questions as per a predefined checklist for'}, {'measure': 'Neonatal Mortality', 'timeFrame': 'Antepartum upto 30 days post delivery', 'description': 'Number of neonatal deaths'}, {'measure': 'APGAR</= 7 at birth', 'timeFrame': 'Upto 5 mins after birth', 'description': 'The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.'}, {'measure': 'Number of infants with meconium aspiration syndrome (MAS)', 'timeFrame': 'Delivery through discharge or upto 4 days post delivery whichever is earlier', 'description': 'Number of infants with MAS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Elective induction of labour'], 'conditions': ['Pregnancy Related']}, 'descriptionModule': {'briefSummary': 'Adverse events are considered to increase in pregnancies extending beyond 39 weeks.\n\nFor multiparous patients, especially those with a favourable cervix, it is perhaps easy to justify an elective induction at 39 weeks given the low risk of caesarean section.\n\nHowever, for nulliparous patients the current evidence, derived mainly from retrospective observational studies, does not allow a clear recommendation with the exception perhaps of the recent A Randomized Trial of Induction Versus Expectant Management (ARRIVE) trial. Given the reported increased risks of adverse events in pregnancies extending beyond 39 weeks it has been hypothesized that a policy of planned elective induction at 39 weeks could improve outcomes for the infant and the mother. There is a trend towards an increased rate of elective labour induction in pregnancies at 39 weeks, indicating that practitioners are more commonly using elective induction at this gestational age. The practice in India varies slightly from institute to institute.\n\nThe investigator intend to study the maternal and perinatal outcome, after elective induction of labour, at thirty nine weeks and zero days upto thirty nine and six days, amongst nulliparous singleton pregnancies followed up for the duration of their hospital stay, in Jubilee Mission Medical College and Research Institute (JMMC and RI).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Singleton nulliparous gestation undergoing elective induction between 39weeks and 0days -39weeks and 6 days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Nulliparous - no previous pregnancy beyond 20 weeks\n2. Singleton gestation.\n3. Undergoing elective induction between 39weeks and 0days -39weeks and 6 days based on clinical information and evaluation of the earliest ultrasound as described in Gestational Age\n4. Consenting to be part of the study\n\nExclusion Criteria:\n\n1. Plan for caesarean delivery or any contraindication to vaginal delivery\n2. Foetal demise or known major foetal anomaly'}, 'identificationModule': {'nctId': 'NCT04597528', 'acronym': 'EIOL39', 'briefTitle': 'Elective Induction of Labour at Thirty Nine Weeks: a Prospective Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Jubilee Mission Medical College and Research Institute'}, 'officialTitle': 'Maternal and Perinatal Outcome After Elective Induction of Labour at Thirty Nine Weeks and Zero Days Upto Thirty Nine Weeks and Six Days in Nulliparous Singleton Pregnancies :a Prospective Observational Study in a Tertiary Care Centre', 'orgStudyIdInfo': {'id': '42/19/IEC/JMMC&RI'}, 'secondaryIdInfos': [{'id': 'U1111-1245-7675', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Elective induction group', 'description': 'Nulliparous singleton gestations undergoing elective induction between 39weeks and 0days -39weeks and 6 days based on clinical information and evaluation of the earliest ultrasound as described in Gestational Age', 'interventionNames': ['Other: Elective Induction']}], 'interventions': [{'name': 'Elective Induction', 'type': 'OTHER', 'description': 'All patients admitted to the labour room would be approached to be enrolled in the study.\n\nThose satisfying the inclusion and exclusion criteria would be prospectively enrolled to the study after procuring an informed consent. If a patient appears to meet the criteria for the study, she will be told about the study and asked for written informed consent to participate. Consent may be obtained anytime from 34 weeks 0 days to 38 weeks 6 days of gestation. Data would be procured on a pre set proforma, entered in real time and safely stored.\n\nThe data would later be abstracted to an excel sheet.', 'armGroupLabels': ['Elective induction group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '680005', 'city': 'Thrissur', 'state': 'Kerala', 'country': 'India', 'facility': 'Jubilee Mission Medical College and Research Institute', 'geoPoint': {'lat': 10.51667, 'lon': 76.21667}}], 'overallOfficials': [{'name': 'Sareena Gilvaz, MD, DGO', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Jubilee Mission Medical College and Research Institute'}, {'name': 'Bindu Menon, MS', 'role': 'STUDY_CHAIR', 'affiliation': 'Jubilee Mission Medical College and Research Institute'}, {'name': 'Athulya Shajan, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jubilee Mission Medical College and Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jubilee Mission Medical College and Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Junior Resident', 'investigatorFullName': 'Athulya Shajan', 'investigatorAffiliation': 'Jubilee Mission Medical College and Research Institute'}}}}